Awards & quality
Clearances, licenses, awards and quality system
Our technology holds clearances and licenses in the United States, the European Union, Taiwan, Thailand, the Philippines and Malaysia, and it has been recognized twelve times since 2017.
Regulatory clearances
Cleared and licensed for the markets we sell in
Each clearance or license 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: K220554 (opens in a new tab) (decision date 16 December 2022) and K242271 (opens in a new tab) (decision date 30 October 2024). Both are for Caduceus S. That clearance is what allows the system to be marketed in the United States.
FDA 510(k) devices are described on this site as cleared.
CE marking — European Union
The Foresee-X AR glasses are CE marked as a Class I device under MDR (EU) 2017/745.
Taiwan TFDA licenses
All three device lines are licensed by Taiwan’s Ministry of Health and Welfare: Caduceus S under MOHW-MD-No. 008401, Foresee-X under MOHW-MD-No. 007801 and OOOPDS under MOHW-MD-No. 007110. OOOPDS is also cleared by the US FDA under 510(k) K254214.
Thai FDA license
The Caduceus S surgical navigation system holds Thai FDA import license No. 66-2-3-2-0016533, issued in December 2023 and valid until December 2028.
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 license | Numbers on record | Markets |
|---|---|---|---|
| Caduceus S — AR Navigation | US FDA 510(k) cleared, Class II license in Taiwan, Thai FDA licensed, registered in the Philippines and Malaysia | K220554 · K242271 · MOHW-MD-No. 008401 · 66-2-3-2-0016533 · CMDR-2026-07185 · GB9538225-201721 | United States · Taiwan · Thailand · Philippines · Malaysia |
| Foresee-X AR Glasses | CE marked as a Class I device under MDR (EU) 2017/745, TFDA Class II medical device license | MOHW-MD-No. 007801 · DE/CA22/00162073 | European Union · Taiwan |
| OOOPDS Surgical Planning | US FDA 510(k) cleared, TFDA Class II medical device | K254214 · MOHW-MD-No. 007110 | United States · Taiwan |
| Virtual dissection tables | Not a medical device — general electronic product compliance | CE-EMC · CE-LVD · US FCC · WEEE · RoHS · REACH | European Union · United States |
Availability, and which clearances and licenses 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 quality system
A clearance says a device may be sold. A quality system governs how it is made — 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 under certificate TW21/10627, valid until 24 December 2027. It covers risk management, traceability and continuous improvement, and it is re-audited rather than granted once — we have held the certificate since December 2021.
Taiwan QMS 2187
Production runs under Taiwan QMS certificate QMS2187, issued by the Ministry of Health and Welfare and valid until 1 August 2029.
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, organized 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
If your hospital, distributor or regulatory team needs a copy of a clearance, license or ISO certificate for review, ask and we will send it. A demonstration can be arranged at the same time.