Contact:haixiao@sungolytest.com+86 158 2169 5110 (WeChat)+86 132 4819 8029 Members 中文
Home›Taiwan›BIOPTIK TECHNOLOGY, INC.

BIOPTIK TECHNOLOGY, INC.

Taiwan · Miaoli County · www.bioptik.com.tw
✓ Record-verifiedregistrations found in 5 marketsEU SRN TW-MF-000047723

This company has registrations in European Union, United States, Singapore, Australia, Russia — 5 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
6device registrations
CLASS B 4CLASS C 2
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
1active ARTG entries
IVD Class 3 1
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
pendingnot queried
RURussiaRoszdravnadzor
5active registrations
Class 2a 2Class 2b 3
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 Union2 raw hits, 0 excluded, 2 confirmed
United States3 registration records, 1 510(k), 0 PMA
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. HSINCHU SCIENCE. 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
Miaoli County
Website
www.bioptik.com.tw
Product categories
Clinical Diagnostics & Therapeutic TechnologiesLaboratory, IVD & DiagnosticsHome & self-testing

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

Similar companies

Apex Biotechnology Corporation
Taiwan · markets 6
Bionime Corporation
Taiwan · markets 8
HMD BioMedical Inc.
Taiwan · markets 3
TaiDoc Technology Corporation
Taiwan · markets 9
Baso Biotech Co., Ltd.
Taiwan · markets 1
BiOptic Inc.
Taiwan · markets 1
Is this your company? Claim the page, add information or report a data error.Claim / report an error →