Circuitwise expands footprint in Australia with acquisition of IntelliDesign Pty Ltd

17 December 2025 – Australian-headquartered Circuitwise Group has completed the acquisition of IntelliDesign Pty Ltd (‘IntelliDesign’), an Australian electronics design and manufacturing specialist based in Brisbane. This marks the group’s fourth site, following the integration of Christchurch-based ASL and Auckland-based Nautech Electronics with Sydney-based Circuitwise Electronics.

The acquisition further strengthens Circuitwise Group’s presence across Australia and New Zealand and supports its commitment to quality-led, regionally delivered manufacturing services. IntelliDesign’s engineering capability, long-standing customer partnerships, and experience building products for demanding environments complement Circuitwise’s focus on high-reliability applications and sectors, including medical technology, defence, aerospace, and advanced industrials.

Local manufacturing continues to grow in importance for organisations seeking improved delivery speed and reliability, enhanced communication and responsiveness, design-for-manufacture collaboration, reduced exposure to geopolitical tensions and supply chain disruption, and stronger control over intellectual property. With facilities now spanning Sydney, Brisbane, Auckland, and Christchurch, Circuitwise Group is well positioned to support these needs across the region.

Serena Ross, CEO, Circuitwise Group, said, “Circuitwise is delighted to welcome IntelliDesign to the group. Its engineering depth and manufacturing capability align with our quality-led approach and commitment to delivering consistent outcomes for customers across high-reliability sectors. Together, we will offer broader capability, greater capacity, and increased regional resilience for our clients.”

Matt Bromwich, CEO, IntelliDesign, said, “Becoming part of the Circuitwise Group lets IntelliDesign extend its capability while staying true to the values that have guided us for more than three decades. Our teams share a commitment to disciplined engineering and responsive service, and we look forward to creating even more value for our customers through this partnership.”

The acquisition is expected to benefit all stakeholders, including staff, management, and customers. IntelliDesign will continue to operate under its existing brand, with its leadership team remaining in place. Integration activities will focus on increasing productivity, strengthening the Group’s value added design services, enhancing traceability, and aligning with Circuitwise’s established quality management systems.

Following completion of the transaction, Circuitwise Group now operates four modern facilities across Australia and New Zealand, supported by a team of approximately 300 specialists. This offers expanded capability, increased manufacturing capacity, and improved supply chain resilience for customers seeking reliable and local electronics manufacturing services.

-ENDS-

About Circuitwise Group

Circuitwise Group is a leading Australasian provider of precision electronics design and manufacturing services, operating facilities in Sydney, Brisbane, Auckland, and Christchurch. The Group delivers PCBA, box-build assembly, test development, and design-for-manufacture expertise under ISO 9001, ISO 13485, and AS 9100D-certified quality systems. Circuitwise Group combines disciplined processes, full traceability, and responsive local service to support customers with products that demand regulatory compliance and business critical reliability

Building a stronger electronics manufacturing network across Australasia

At Circuitwise, we are committed to building a more capable and responsive manufacturing network that meets the needs of customers across the region.

Our recent acquisition of Assembly Specialists Limited (ASL) in Christchurch, following the earlier acquisition of Nautech Electronics in Auckland, marks the next step in this effort. These businesses are now part of the Circuitwise Group, which supports customers across Australia and New Zealand with high-quality electronics manufacturing and product development.

This expansion reflects our long-term investment in regional capability. We are building a network that delivers reliable local manufacturing, greater production capacity, and advanced capabilities backed by best-practice processes, robust systems, and shared values.

A network that supports local industries

Circuitwise now operates three sites across Australasia: Sydney; Auckland; and Christchurch. Each site brings something unique to the group, and all deliver services through proven quality management systems and standards.

Our customers benefit from access to:

  • local production and engineering expertise
  • robust traceability and inspection systems
  • consistent services through reliable quality management systems
  • a broader pool of specialised capabilities
  • improved capacity, scheduling, and delivery options.

Having multiple sites means we can manage risk, support complex delivery schedules, and be flexible when it comes to meeting our customers’ needs without compromising on quality or service.

Why local capability matters

Australia and New Zealand are home to world-class businesses across sectors like aerospace, agriculture, marine, medical, defence, and industrial technology. These industries rely on electronics manufacturing that is precise, traceable, and adaptable.

We support these businesses with services that are:

  • geographically closer to design and development teams
  • better aligned with local compliance needs
  • less exposed to offshore supply chain disruption
  • easier to scale and adjust as programs grow.

Staying close to the manufacturing line improves outcomes, reduces risk of shipping delays, and supports stronger collaboration for customers working on long-term programs or high-value products.

Bringing together complementary strengths

The Circuitwise Group combines the capabilities of three established businesses, united by a shared focus on high-reliability manufacturing, engineering collaboration, and long-term customer partnerships. Together, we deliver comprehensive support throughout the entire product lifecycle from design, prototyping, and design for manufacture (DFM) through to scaled production, new product introduction (NPI), and ongoing maintenance.

  • Circuitwise in Sydney has a strong history of supporting clients with high-reliability requirements in industries such as medical and defence. Its proprietary systems provide advanced monitoring, inspection, and quality control to maintain compliance in the most demanding applications.
  • Nautech in Auckland brings decades of experience working with law enforcement, marine, and aerospace sectors to the Group. Its team is highly skilled in product design, prototyping, and turnkey product assembly, backed by a reputation for practical problem-solving and reliability.
  • ASL in Christchurch has a proven track record supporting agriculture, industrial, and automotive markets. With expertise from NPI through to scaled production, ASL is recognised for its responsiveness and consistent delivery of high-quality outcomes.

By aligning best-practice processes across the group, we preserve the distinct strengths and histories of each site while offering customers a broader, more integrated set of services. The result is a partner that combines specialist expertise with the confidence and scale of a unified network.

Building regional capacity and resilience

The addition of Nautech and ASL increases our group’s overall production capacity and geographic coverage. This helps us manage peaks in demand, support more customers, and reduce reliance on any single location.

It also strengthens supply chain resilience. Regional manufacturing capacity gives customers more control and visibility, especially in industries where long lead times, global disruptions, or rapid iteration cycles create pressure.

Having qualified teams on both sides of the Tasman means we can support customers who are expanding, reshoring, or managing long-term delivery programs with more confidence and flexibility.

Our expansion into New Zealand is a long-term investment in regional capability. It reflects the growing demand for high-reliability manufacturing in sectors where local support, quality control, and supply chain resilience are critical.

No changes to your relationship

For existing customers of Circuitwise, Nautech, or ASL, your account team and day-to-day contacts remain the same. The people who know your projects will continue to support it.

What changes is the level of support now available to you. There are now more options available through the broader Circuitwise Group, whether you need to scale production, manage delivery risk, or explore new product capabilities.

Please get in touch with your account manager or contact us directly if you have questions about what this means for your business. We are happy to talk through how this expansion could support your goals.

Looking ahead

We are proud to welcome ASL and Nautech to the Circuitwise Group and to continue investing in high-quality electronics manufacturing across the region.

As our customer base grows, our focus remains on doing what we have always done well: supporting complex, high-reliability projects with consistent quality, responsive service, and a long-term mindset.

We look forward to what comes next and to working even more closely with our customers across Australasia.

FDA audit success driving US access

Circuitwise is pleased to announce it has successfully passed an audit conducted by the US Federal Drug Administration. This audit enables Circuitwise to continue its establishment registration on the FDA’s FURLS database as a contract manufacturing establishment for medical devices.

Any company involved in the manufacturing of medical devices sold in the United State must be registered as an official establishment associated with that product. This applies to the registered manufacturer, any contract manufacturer, specification developer and sterilization provider, among other categories.

Circuitwise first gained Establishment Registration in late 2021. This registration makes it easier for our customers to ship finished devices directly from Circuitwise to US market. For new devices/customers, it is as simple as adding another line to the existing device listing. As part of that commitment, the FDA could choose to audit Circuitwise at any time. That time came a few months ago and the quality team at Circuitwise was subjected to a rigorous audit by a US audit team.

We just received confirmation that we passed easily with minor observations. The audit criteria were based on 21 CFR 820. The audit scope was the entire manufacturing process and not just the listed product.

This standard is similar to the medical devices quality standard ISO13485, with some minor differences. FDA is updating 21 CFR 820 to better align the stow standards. It said:

“This action continues the FDA’s efforts to align its regulatory framework with that used by other regulatory authorities to promote consistency in the regulation of devices and provide timelier introduction of safe, effective, high-quality devices for patients”

This audit outcome is an independent confirmation of how high our quality management systems are,  in particular, our ISO 13485 quality management certification for the manufacture of medical devices.

FURLS is an acronym for FDA Unified Registration and Listing System. It is the system the FDA provides for applicants to register online and make electronic submissions.

Establishments must reregister annually, and this system facilitates easy updates to the information provided. Information updates include listing the range of medical devices a contract manufacturer is involved in, that are marketed in the US, and the activities performed.

Establishment registration is a separate process from obtaining regulatory approval for a medical device in the US, typically through a 510(k) clearance or Premarket Approval (PMA).

Circuitwise acquires Nautech Electronics

The leading electronics manufacturers in both Australia and New Zealand have become one team 

Quadrant Private Equity supports Circuitwise Electronics growth with acquisition of New Zealand’s Nautech Electronics

Press Release: 10 September 2024

Sydney-based Circuitwise Electronics has signed an agreement to acquire Nautech Electronics, New Zealand’s leading electronics design and manufacturing specialist.  The transaction is expected to complete at the end of September 2024.

Circuitwise and Nautech are two of the leading contract electronics manufacturing companies in their respective geographic markets, with a shared focus on quality, reliability and responsiveness for their customers. The partnership extends both companies’ capability and capacity, providing customers with a deeper service offering and a second manufacturing location in the Australia and New Zealand region.

Nautech's electronics manufacturing facility in New Zealand
Nautech’s electronics manufacturing facility in New Zealand

Geographical presence was a key consideration in this strategic partnership.  Local manufacturing is increasingly important for Australian and New Zealand companies looking for better delivery speed and reliability; enhanced communication and responsiveness; collaboration and support for testing and design for manufacture; reduced vulnerability to geopolitical disputes and tariff fluctuations; and stronger intellectual property protection. With its close ties to Australia under the auspices of the Closer Economic Relations Agreement, New Zealand provides this assurance.

Circuitwise Electronics’ CEO, Serena Ross, said she had been looking for companies that shared Circuitwise’s obsession with quality, and Nautech was the perfect match.

“Quality is their number one priority, and we wanted to partner with another company with leadership and people who have the same culture as us,” Serena said. “Nautech has a strong position in the aerospace industry, which supports our strategy of servicing mission-critical sectors with a high requirement for quality assurance.  Nautech also has several new capabilities to help us deliver an even better service to our customers across Australia and New Zealand.”

Nautech CEO Laurie Kubiak said: “Our company wanted to continue its rapid growth and had been looking for a partner with complementary capabilities to help drive that growth. Circuitwise was a perfect match as it has strengths in different sectors and technical capabilities. Combining the two offers a very powerful service for product manufacturers across both countries.”

Nautech extends Circuitwise’s offering, with advanced testing facilities and a team of production engineers and electronics designers. The testing facilities include clean rooms and environmental test chambers to recreate extreme temperatures and vibration. Clean rooms are typically required for space and medical applications. The production engineers support the quality process by ensuring all products meet requirements. The design team focuses on providing customers with a complete service to ensure higher reliability of their designs, including design for manufacture.

Factory floor at Nautech
Factory floor at Nautech

Similarly, Circuitwise has capabilities that complement Nautech, having developed a sophisticated enterprise manufacturing system in-house, supported by custom hardware solutions, which provides the group with a clear competitive advantage.

Circuitwise’s proprietary system enables an unprecedented level of traceability that underpins their quality assurance, proven with over 15 years of operation in medical device manufacturing under ISO 13485 and, more recently, under the AD 9100D for aerospace applications. In the past four years, continual improvements to these systems have delivered a three-fold increase in revenue while maintaining the same team size.

Laurie Kubiak said a recent SIRI (Smart Industry Readiness Index) assessment placed Nautech in the top 5% of advanced manufacturers in the world. Combining this with Circuitwise’s advanced systems will re-enforce the group’s market leading capabilities, globally.

The acquisition of Nautech is the first following the investment in Circuitwise Electronics by Quadrant Private Equity last year. Quadrant invests in companies with a high growth potential and supports companies develop clear business plans and long-term strategies to benefit all stakeholders.

Quadrant was highly impressed by the leadership team, the culture and the systems at Circuitwise. The purpose of the acquisition, from Quadrant’s perspective, is to build on that winning formula and transfer it to like-minded companies in the same sector.

Marcus Darville, Chair of Circuitwise, said: “It was clear from the outset that the founders Andrew and Alison Turner, Laurie and the broader Nautech team shared Circuitwise’s strong passion for innovation, an unwavering focus on quality and a culture of going above and beyond for their clients.  We are committed to continuing to invest in the latest technology and supporting ingenuity to accelerate the combine group’s leadership in electronics manufacturing and product engineering, globally.”

The acquisition is good news for all stakeholders, including staff, management and customers. The leadership team at Nautech will remain in place and the Nautech brand will continue. Any changes will focus on productivity improvement leveraging Circuitwise’s systems.

With this acquisition, the Circuitwise group of companies will be the largest electronics manufacturing service that operates wholly within Australasia. Customers will benefit from the increased capability of the group and the assurance of a second manufacturing site to support them.

For more information contact:

Serena Ross, CEO

Circuitwise Electronics

sales@circuitwise.com.au                                                                        

Laurie Kubiak, CEO

Nautech Electronics

https://www.nautech.com

sales@nautech.com

Asset tracking manufacturer chooses Australian-made

Circuitwise welcomes working with another client who wants to start manufacturing their products in Australia. An order was delivered to Adapt Ideations recently, cementing the start of a relationship that both companies hope will grow.

Adapt Ideations supplies asset tracking and monitoring devices for high-value and temperature-sensitive products, such as those in the pharmaceutical and perishable goods industries. The trackers can be charged via a single USB cable, but some users need to be able to charge up to 50 devices at a time.

Adapt Ideations provides customers the ability to use mass charging boards in which a number of devices can be charged at the same time without individually having to connect each device to a USB cable and subsequently into a power socket to charge.

Adapt Ideations' mass charger
Adapt Ideations’ mass charger

While Adapt Ideations has established relationships with contract manufacturers globally, the company wanted a local manufacturer to provide it with the flexibility and speed of delivery it required for its small volume jobs. In addition, many of its customers want the assurance of supply chain continuity that comes with local manufacturing in Australia.

“This initial collaboration is a small step towards a larger goal of diversifying our supply base to deliver supply chain security and improve the sustainability of our operations as we move forward”, said Anirban Gupta, Co-Founder and Director of Adapt Ideations. “We are looking to do more manufacturing in Australia, and we look forward to working more with Circuitwise in the future”.

Circuitwise CEO Serena Ross said it was another example of the benefits of manufacturing in Australia, particularly for small to medium-sized production runs of high-value products.

“There are many good reasons for manufacturing in Australia,” Serena said, “including speed and reliability, responsiveness, ease of communication, reduced tariffs and intellectual property protection.

“Covid-19 revealed our country’s vulnerability to supply chain disruptions, and the smart thing for all Australian manufacturers to do is have at least one manufacturer of your product in Australia.”

Circuitwise recognised as a top 10 most innovative manufacturer

Circuitwise has been recognised as one of Australia’s 50 Most Innovative Manufacturers for 2024 by AuManufacturing, the publishing arm of the Australian Manufacturing Forum. Circuitwise was awarded a Top 10 Gold Award, beating 40 other Silver awardees and many other companies that did not make the top 50.

Advanced Navigation CEO Xavier Orr awarding Circuitwise CEO Serena Ross the recognition for Australia's top 10 most innovative manufacturer
Advanced Navigation CEO Xavier Orr awarding Circuitwise CEO Serena Ross the recognition certificate

Circuitwise’s application focused on how greater productivity benefits can be obtained through continual improvement rather than a deep tech, “new to the world” approach to innovation. We showed how a cultural change program that empowered the leadership team to drive change in their areas of responsibility ultimately led to a three-fold increase in revenue while maintaining the same number of team members.

A good example of innovation by continual improvement was the implementation of a custom component storage system, with mobile shelving units featuring adjustable individual component bays that light up to guide the operator to the component’s location. This single innovation reduced kitting times from approximately eight hours to about 30 minutes. You can read a summary of our application in a follow-up article for AuManufacturing.

Circuitwise formally certified for QMS requirements for Aviation, Space and Defence industry.

Obtaining a New Certificate of Registration: Circuitwise Adopts AS 9100D Quality Management System Drive Towards Excellence in Aerospace Manufacturing.

For companies operating in industries such as aerospace the need for quality, reliability, and safety is non-negotiable. It is with this goal in mind that we, Circuitwise, a leading electronics manufacturing services provider, is proud to announce our latest achievement of a new Certificate of Registration for its Quality Management System (QMS) which complies with the requirements of AS 9100D.

What is AS 9100D? AS 9100D is an internationally recognized Quality Management System standard specifically tailored for the aerospace industry. Developed by the International Aerospace Quality Group (IAQG), AS 9100D establishes a robust framework for organizations to manage quality, risk prevention, and product safety in their manufacturing processes. This certification reflects Circuitwise’s commitment to adopting best practices, complying with industry regulations, and delivering the highest quality products and services to its aerospace customers.

Benefits of AS 9100D Certification: Achieving AS 9100D certification is a significant milestone for Circuitwise. This certification brings numerous benefits that will help its customers in the aerospace industry. Some of the key benefits include:

  1. Enhanced Confidence: AS 9100D certification assures Circuitwise’s customers that the company is dedicated to meeting their specific needs and requirements. It demonstrates a commitment to continuous improvement and customer satisfaction, which builds trust and confidence in the company’s capabilities. Many aerospace companies and government organizations require suppliers to have AS 9100D certification to ensure that stringent quality standards are met.
  2. Improved Process Efficiency: The AS 9100D standard focuses on process efficiency and risk management. By implementing this QMS, Circuitwise can streamline its processes, identify areas that require improvement, and mitigate risks effectively. This leads to increased operational efficiency, reduced waste, and optimized resource utilization.
  3. Continuous Improvement and Compliance: Certification to AS 9100D is not a one-time achievement but an ongoing commitment to continuous improvement. Circuitwise will regularly assess and improve its processes to maintain compliance and achieve the highest standards of quality, safety, and customer satisfaction.
Quality Management System certification

By obtaining the AS 9100D certification, Circuitwise demonstrates its dedication to maintaining the highest level of quality management practices across its operations. This certification strengthens the company’s position as a reliable and trustworthy partner in the aerospace industry. It provides assurance that Circuitwise’s products and services align with the stringent requirements of customers, regulatory bodies, and industry standards.

Circuitwise’s new Certificate of Registration for operating a Quality Management System that complies with AS 9100D is a testament to its continual commitment to excellence in the aerospace manufacturing industry. This certification not only reaffirms its focus on providing top-quality products and services but also positions the company as a preferred partner for aerospace organizations worldwide. Circuitwise’s dedication to meeting and exceeding customer expectations, mitigating risks, and driving continuous improvement sets a benchmark for other industry players. With the AS 9100D certification, Circuitwise continues to soar to new heights, leading the way in delivering excellence in aerospace manufacturing.

For more information and a case study, see our Aerospace webpage.

Circuitwise awarded grant for custom semiconductor placement capability

Circuitwise is pleased to announce it has received a grant from the Australian Government in Round 2 of the Supply Chain Resilience Initiative (SCRI). A grant of $2,000,000 was awarded to assist the company to upgrade its electronics manufacturing technology.

The upgrade is aimed at enabling the placement of custom chips directly onto printed circuit boards. This new capability will be supported with additional equipment for high-speed product testing as well as clean room facilities for implantable electronics.

Circuitwise CEO Serena Ross said the investment would place Circuitwise among an elite group of companies globally that offered these kinds of services, particularly those that also offer ISO 13485 certified manufacturing of medical device products.

The core technology underpinning this step-change in capability is flip-chip machinery, which is targeted at companies designing products with custom-designed semiconductors such as Application Specific Integrated Circuits (ASIC). Associated advanced automation software will facilitate programming the placement of ASICS on Printed Circuit Board Assemblies (PCBA).

The flip-chip machine will be complemented with a combined underfill and conformal coating station which is required to protect and support the performance of the custom chip on the PCBA. Epoxy underfill ensures the mechanical integrity of the naked chip, reduces thermal stresses on solder joints, avoids moisture ingress and, in some cases, stabilises the performance characteristics of any on-chip sensors.

A key limiting factor for manufacturing products with custom semiconductors in Australia is the time it takes to conduct electrical and functional tests of the device coming off the production line. Designing custom semiconductors, and the associated wafer fabrication, is usually only profitable at very high volumes, in the order of several hundred thousand units a year or millions.

To make testing at high volumes affordable, this grant project also includes the installation of a flying probe machine combined with a 3D optical inspection station. A range of robotic and automated transfer equipment along the assembly line will further reduce manufacturing costs for our clients.

This core technology is only the start of this expansive capability upgrade. The market for custom semiconductor product design is projected to grow with the support of the newly created Semiconductor Sector Service Bureau (SSSB). So Circuitwise is also investing in a range of complementary equipment that will support the commercial manufacturing of the full range of manufacturing techniques for customer semiconductors.

Other machinery to be purchased under this grant includes equipment to enable wire bonding and wire pull testing. We will also purchase a specialised die placement machine that further automates and accelerates the process, as well as greatly expanding the range of die placement methods and options we can offer.

Much of the market for devices with custom semiconductors also requires the above equipment to be operated in a clean room. For example, this is required in the manufacture of sterile devices which is critical for servicing the implantable medical devices market. Under this project, Circuitwise will be installing a clean room, with associated air pressurisation equipment.

Similarly, there are many applications for this technology in the Australian aviation, defence and space industries. As part of this project will be pursuing AS 9100 Rev D quality management certifications which companies from these industries typically require.

While some of these technologies outlined above are available in university labs and a few very large original equipment manufacturers, Circuitwise will be filling a gap in the commercial services available in Australia for this step in the semiconductor value chain.

Globally, there are very few contract electronics manufacturing companies that can offer these services with ISO 13485 certification for medical devices. Circuitwise will be investing nearly $5 million in new technologies to underpin its place at the cutting edge of electronics manufacturing capability.

The Supply Chain Resilience Initiative assists businesses to establish or scale a manufacturing capability to address supply chain vulnerabilities for a critical product or input identified in the Sovereign Manufacturing Capability Plan. In Round 2 the semiconductor industry was one of two areas targeted.

Circuitwise looks forward to working with the Semiconductor Sector Service Bureau to help support Australian companies aiming to take on the world with innovative custom semiconductor designs.

Continuing our support for “active” MedTech in NSW

Circuitwise is proud to be continuing its support for the NSW Active MedTech Community.

We have been sponsoring this community since its inception at the start of 2020. Over that time the community has run an impressive 37 webinars, which can be accessed on the community’s recordings page.

The webinar program has covered a diverse range of topics including case studies, product development, key technical standards, quality systems, regulatory processes, commercialisation processes with regular overviews of the whole field. Taken as a whole, the archive of recordings is an impressive body of knowledge.

The heart of the community revolves around the best practices associated with implementing electronics and software, which largely differentiates “active” medical devices from other kinds of MedTech. While the scope of topics has been broadened to include a range of less technical subjects, the community regularly returns to different aspects of electronics.

Unfortunately, the start of the community coincided with the advent of Covid. Up to date, the community has largely operated online using a webinar format. However, this year (2022) we hope to emphasise the “community” aspects of its program by having more face-to-face events to leverage personal networking opportunities. In addition, the online sessions will move from a webinar format to a meeting format, allowing participants to interact directly with each other.

We helped start this community because no other group in Australia has electronics in medical devices as its core focus. While active MedTech remains a small part of the broader MedTech industry, which includes pharmaceuticals, for those of us operating in this space, it is a big part of our world. So we are proud to be leading the way in helping anyone in this niche feel like they have a professional home and a targeted set of resources.

See the events page for upcoming activities. To get involved in the community, please reach out to the coordinator at coordinator@nswactivemedtech.com.au.

Establishment Registration for Circuitwise opens gates to US

Circuitwise is pleased to announce it has been registered in the United States Federal Drug Administration’s FURLS database as a contract manufacturing establishment for medical devices. This establishment registration will assist any clients exporting their products to the United States.

Any company involved in the manufacturing of medical devices sold in the United State must be registered as an official establishment associated with that product. This applies to the registered manufacturer, any contract manufacturer, specification developer and sterilization provider, among other categories.

FURLS is an acronym for FDA Unified Registration and Listing System. It is the system the FDA provides for applicants to register online and make electronic submissions. Establishments must reregister annually, and this system facilitates easy updates to the information provided. Information updates include listing the range of medical devices a contract manufacturer is involved in, that are marketed in the US, and the activities performed.

Establishment registration is a separate process from obtaining regulatory approval for a device, typically through a 510(k) clearance or Premarket Approval (PMA).