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Home›Taiwan›BIOPTIK TECHNOLOGY, INC. HSINCHU SCIENCE

BIOPTIK TECHNOLOGY, INC. HSINCHU SCIENCE

Taiwan · Hsinchu City · www.bioptik.com.tw
✓ Record-verifiedregistrations found in 2 marketsEU SRN TW-MF-000047723

This company has registrations in European Union, United States — 2 overseas markets. The China NMPA lookup is still pending.

Registrations by market

Each market counts a different unit; figures are not directly comparable
CNChinaNMPA
pendingnot queried
EUEuropean UnionEUDAMED
2UDI-DI device records
Class I 2
USUnited StatesFDA openFDA
4listed device types
Class I 3Class II 1Class III 0
plus 3 registration records and 1 510(k)
UKUnited KingdomMHRA PARD
0registered device records
BRBrazilANVISA
0registered devices
this export covers Class I / II only (the cadastro route)
SASaudi ArabiaSFDA
0registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
0active device licences
TWTaiwanTFDA
pendingnot queried
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
pendingnot queried
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
pendingnot queried
RURussiaRoszdravnadzor
pendingnot queried
Not yet connected: India CDSCO, Indonesia Kemenkes. The public search for Japan PMDA and Vietnam IMDA does not return manufacturer names, so entries cannot be linked to companies coming — where there is no data it is shown as "pending", never estimated.

How these numbers were verified

record-verified

Company-name search in every official database is a substring match and returns same-named but different companies. Each figure below is the count after re-checking every record against the manufacturer name.

European Union5 raw hits, 3 excluded, 2 confirmed
United States3 registration records, 1 510(k), 0 PMA
United Kingdom0 confirmed, 1 excluded
Manufacturer names merged into this page: BIOPTIK TECHNOLOGY, INC. HSINCHU SCIENCE PARK BRANCH · Bioptik Technology, Inc.
Same-named companies — This database also contains companies with near-identical names: BIOPTIK TECHNOLOGY, INC.. Company name alone cannot separate their registrations, so the figures below may include either.

Regulatory identity

EU manufacturer SRN
TW-MF-000047723
EU authorised representative
KOMAS Medical Technology GmbH

Company information

Country
Taiwan
City
Hsinchu City
Website
www.bioptik.com.tw
Product categories
Clinical Diagnostics & Therapeutic TechnologiesOrthopaedics, Trauma & RehabilitationTrauma systems

Fields marked "pending" have not been obtained yet; that does not mean they do not exist. Risk records (litigation, penalties, operating anomalies) are kept internal and not published.

FDA 510(k) clearances by year

12006 · K053312

FDA listed device types

Multi-Analyte Controls, All Kinds (Assayed) 1Dressing, Wound, Hydrogel Without Drug And/Or Biologic 1Silicone Hydrogel For Scar Management 1System, Test, Blood Glucose, Over The Counter 1

Registration details (sample)

MarketIdentifierNameClass / date
EU04710614721791—Class I
EU04710614725072—Class I
USK053312EASYMATE BLOOD GLUCOSE MONITORING SYSTEM2006-03-01

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