HomeKorea, RepublicOsang Healthcare Co., Ltd.

Osang Healthcare Co., Ltd.

Korea, Republic · Anyang-si Gyeonggi-do · www.osanghc.com
✓ Record-verifiedregistrations found in 9 marketsEU SRN KR-MF-000032605

This company has registrations in European Union, United States, United Kingdom, Brazil, Canada, Singapore, Australia, Israel, Russia — 9 overseas markets. The China NMPA lookup is still pending.

Registrations by market

Each market counts a different unit; figures are not directly comparable
CNChinaNMPA
n/aThis registry lists domestic registrants only
EUEuropean UnionEUDAMED
139UDI-DI device records
IVD A 12IVD general 6ivd-annex-ii-list-b 119ivd-devices-self-testing 2
USUnited StatesFDA openFDA
14listed device types
Class I 5Class II 7Class III 0unclassified 2
plus 17 registration records and 3 510(k)
UKUnited KingdomMHRA PARD
10registered device records
IVD A 3IVD general 1IVD Annex II List B 6
BRBrazilANVISA
23registered devices
Class II 23
49 including historic records
SASaudi ArabiaSFDA
0registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
1active device licences
Class III 1
3 including historic records
TWTaiwanTFDA
0valid device licences
SGSingaporeHSA SMDR
1device registrations
CLASS B 1
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
2active ARTG entries
IVD Class 2 1IVD Class 3 1
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
2registrations
RURussiaRoszdravnadzor
8active registrations
Class 2b 1Class 3 7
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 Union139 raw hits, 0 excluded, 139 confirmed
United States17 registration records, 3 510(k), 0 PMA, 2 excluded
United Kingdom10 confirmed, 0 excluded
Brazil23 confirmed, 0 excluded
Canada1 confirmed, 0 excluded
Manufacturer names merged into this page: OSANG Healthcare CO., LTD. · OSANG HEALTHCARE CO., LTD. · OSANG HEALTHCARE CO.,LTD.

Regulatory identity

EU manufacturer SRN
KR-MF-000032605
EU authorised representative
Obelis s.a.
UK responsible person
Obelis UK Ltd

Company information

Country
Korea, Republic
City
Anyang-si Gyeonggi-do
Website
www.osanghc.com
Product categories
Clinical Diagnostics & Therapeutic TechnologiesLaboratory, IVD & DiagnosticsPoint-of-care & near-patient 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.

Business registration

KRX ticker code
036220
Registration status
Active
Incorporated
2024-03-13

Business registration data from KRX KIND, retrieved 2026-09-02. Public registry information only; details of directors and shareholders are not collected.

FDA 510(k) clearances by year

12018 · K182286
12020 · K201396
12021 · K203562

FDA listed device types

showing 8 of 14
Glucose Oxidase, Glucose 1Multi-Analyte Respiratory Virus Antigen Detection Test 1Over-The-Counter Covid-19 Antigen Test 1Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature 1Multiple Use Blood Lancet For Single Patient Use Only 1System, Test, Blood Glucose, Over The Counter 1Glucose Dehydrogenase, Glucose 1Kit, Direct Antigen, Positive Control 1

Registration details (sample)

MarketIdentifierNameClass / date
EU08809115900562GlucoCheck Excellent Blood Glucose Monitoring System for self-testing (mmol)ivd-annex-ii-list-b
EU08809115904560GlucoCheck Excellent Blood Glucose Control Solution (High)ivd-annex-ii-list-b
EU08809115900333GlucoCheck Excellent Blood Glucose Test Stripivd-annex-ii-list-b
EU08809115901330GlucoCheck Excellent Blood Glucose Test Stripivd-annex-ii-list-b
UK41819Element Blood Glucose Control SolutionIVD Annex II List B
UK41819Finetest Lite Control SolutionsIVD Annex II List B
UK53307Element Blood Glucose Test StripsIVD Annex II List B
USK203562Finetest Lite Blood Glucose Monitoring System2021-07-13
USK201396Finetest Lite Smart Blood Glucose Monitoring System2020-10-16
USK182286Oh'Care Lite Smart Blood Glucose Monitoring System2018-09-19
BR81914040020CLOVER A1c SELF - CartuchoClass II
BR81914040022LipidPro Solução Controle de Colesterol TotalClass II
BR81914040023LipidPro Solução Controle de Colesterol - HDLClass II
CA80434GLUCOLABClass III

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