Awards & quality
Four markets, twelve awards, one quality system
We are committed to delivering high-quality medical devices that meet international standards, so that healthcare professionals and their patients can rely on them. Our technology holds clearances and licences in the United States, the European Union, Taiwan and Thailand, and it has been recognised twelve times since 2017.
Regulatory clearances
Cleared and licensed for the markets we sell in
Each certification names a specific product, and each is listed here with the number a hospital’s regulatory or procurement team will ask for.
The Caduceus S AR Computer Surgical Navigation System has received FDA 510(k) clearance under K220554, confirming its safety and effectiveness. That clearance is what allows the system to be used in US clinical settings, where it places real-time AR navigation directly in the surgeon’s field of view.
A 510(k) device is cleared, not approved. The FDA reserves “approved” for a different regulatory pathway and enforces the distinction, so we keep to it on every page and in every document.
CE certification — European Union
The Foresee-X AR glasses are CE certified against European safety, health and environmental protection requirements for medical devices, which is what allows them to be marketed and used across the European Union.
Taiwan TFDA licences
All three device lines are licensed by Taiwan’s Ministry of Health and Welfare: Caduceus S under No. 007161 and No. 007725, Foresee-X under No. 007801 and OOOPDS under No. 007110.
Thai FDA certification
The Caduceus S AR navigation system obtained Thai FDA certification in January 2024, confirming that it meets Thailand’s safety and performance requirements for medical devices.
Product by product
Which product is cleared where
One table, so nobody has to open four product pages to answer a procurement question. Every entry is the status stated on the product’s own page.
| Product | Clearance or licence | Numbers on record | Markets |
|---|---|---|---|
| Caduceus S — AR Navigation | US FDA 510(k) cleared, Class II licence in Taiwan, Thai FDA certified | K220554 | United States · Taiwan · Thailand |
| Caduceus S — Navigation | Licensed by Taiwan’s TFDA as medical devices | No. 007161 · No. 007725 | Taiwan |
| Foresee-X AR Glasses | CE certified, TFDA Class II medical device licence | No. 007801 | European Union · Taiwan |
| OOOPDS Surgical Planning | TFDA Class 2 medical device | No. 007110 | Taiwan |
Availability, and which approvals apply, vary by country. Tell us the market you are buying for and we will confirm what is in place for it.
Quality assurance
The system behind the certificates
A clearance says a device may be sold. A quality system is what makes the hundredth unit identical to the first — which is why both belong on this page.
SGS ISO 13485:2016
Our manufacturing and quality management system is certified by SGS to ISO 13485:2016, the international standard for medical device quality management. It covers risk management, traceability and continuous improvement, and it is re-audited rather than granted once.
GMP 1256
Production follows GMP 1256, so devices are built under controlled manufacturing conditions with the safety, quality and consistency checks that medical device production requires.
Awards & recognition
Twelve awards, and what each one was for
These are the awards themselves, not badge artwork. Every one of them names a product or the company on its own plate, so each entry below says which.
2024
Taiwan Excellence Award
For the Asclepius multi-touch digital anatomy tables — TBK-43 LT, 65 4K, 84 EA and 99 EA. Taiwan’s national mark for products that compete abroad on design and quality.
2020
Taiwan Excellence Gold Award
The 28th Taiwan Excellence Awards, gold class, for the Caduceus digital surgical eyewear guidance system.
2019
Edison Award — Bronze
Bronze in the 2019 Edison Awards, for Caduceus. Named after Thomas Edison, the awards judge innovation in new products and services.
2019
CES Innovation Award — Honoree
Named a 2019 honoree in Wearable Technologies for Caduceus, at the Consumer Electronics Show in Las Vegas.
2019
COMPUTEX d&i Award
Honoree in the Startups category for Caduceus, at COMPUTEX’s design and innovation awards, organised by TAITRA and the Taipei Computer Association.
2019
Innovative Product Award
For Foresee-X, presented by the Central Taiwan Science Park Administration, where the company is based.
2018
R&D 100 Award
The Smart Surgical Glasses System was selected as one of the 100 most technologically significant new products of the year in IT and electrical — an award often called the Oscars of innovation.
2018
Innovative I.T. Products — Golden Award
Top 100 Innovative Products, gold class, at Taiwan’s ICT Month in November 2018, for Foresee-X.
2018
IAPS Award
Presented to Taiwan Main Orthopaedic Biotechnology in 2018.
2018
SmartInnoAp Award
Startup class in the second Smart Innovation Application competition.
2018
Entrepreneurial Star — Winner
Winner in the third Startup Star selection, run by the Economic Daily News.
2017
National Innovation Award
The 14th National Innovation Award, startup enterprise class, presented in December 2017 — the company’s first award, in the year it was founded.
Twelve awards from 2017 to 2024, across both product lines and every stage of the work: an early prototype judged at CES and by the Edison panel, the surgical eyewear judged again in Taiwan and by R&D 100, and a shipping anatomy table carrying Taiwan’s national quality mark.
Due diligence welcome
Ask us for the certificate, not just the claim
If your hospital, distributor or regulatory team needs a copy of a clearance, licence or ISO certificate for review, ask and we will send it. A demonstration can be arranged at the same time.