HomeKorea, RepublicOsteosys Co., Ltd.

Osteosys Co., Ltd.

Korea, Republic · Seoul · www.osteosys.com
✓ Record-verifiedregistrations found in 10 marketsEU SRN KR-MF-000010177Unified social credit code 91310000599718536L

This company holds 2 NMPA certificates in China and has registrations in European Union, United States, United Kingdom, Brazil, Taiwan, Singapore, Australia, Hong Kong, Russia — 9 overseas markets.

Registrations by market

Each market counts a different unit; figures are not directly comparable
CNChinaNMPA
2China registrations
Class II 2
as of 2026-09-04
EUEuropean UnionEUDAMED
3UDI-DI device records
Class IIa 3
USUnited StatesFDA openFDA
1510(k) clearances
Class I 0Class II 0Class III 0
plus 0 registration records and 1 510(k)
UKUnited KingdomMHRA PARD
2registered device records
Class IIa 1Class IIb 1
BRBrazilANVISA
0registered devices
1 including historic records
SASaudi ArabiaSFDA
0registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
0active device licences
TWTaiwanTFDA
2valid device licences
Class II 2
SGSingaporeHSA SMDR
5device registrations
CLASS B 3CLASS C 2
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
5active ARTG entries
IIb 5
HKHong KongMDACS
2valid listings
Class II 2
ILIsraelAMAR
pendingnot queried
RURussiaRoszdravnadzor
3active registrations
Class 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 Union3 raw hits, 0 excluded, 3 confirmed
United States0 registration records, 1 510(k), 0 PMA
China2 certificates (Class III 0 / II 2 / I 0), as of 2026-09-04
United Kingdom2 confirmed, 0 excluded
Manufacturer names merged into this page: OSTEOSYS CO., LTD

Regulatory identity

EU manufacturer SRN
KR-MF-000010177
EU authorised representative
CMC Medical Devices & Drugs SL
UK responsible person
MIS Healthcare Ltd
Unified social credit code
91310000599718536L
Exhibition record
CMEF 87th (Spring 2023, Shanghai) · CMEF 89th (Apr 2024, Shanghai) · CMEF 93rd (Apr 2026, Shanghai)

Company information

Country
Korea, Republic
City
Seoul
Social-insurance enrolees
15
Annual revenue
RMB 50–100M
Website
www.osteosys.com
Product categories
Clinical Diagnostics & Therapeutic TechnologiesDiagnostics, Imaging & Nuclear MedicineRadiology & Imaging SystemsX-ray (analog, digital, mobile)

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

Registration status
Active
Incorporated
2012-08-09
Registered capital
USD 150,000
Paid-in capital
USD 150,000
Legal form
Limited liability company (foreign-invested, not wholly owned)
Industry classification
Wholesale trade
Last approval date
2024-12-10
Recognitions
Micro and small enterprise

Business registration data from Tianyancha, as of 2026-09-02. Public registry information only; legal representative and contact-person details are not collected. The figure is the number of employees enrolled in social insurance as declared by the company, which may differ from actual headcount.

FDA 510(k) clearances by year

12005 · K050866

Registration details (sample)

MarketIdentifierNameClass / date
CN沪械注准20262060282双能X射线骨密度仪Class II
CN沪械注准20252060363双能X射线骨密度仪Class II
EU08800008400091BeeTLeClass IIa
EU08800008400039SONOST-2000Class IIa
EU08800008400046SONOST-3000Class IIa
UK40779BeeTleClass IIa
UK37661Excellus, PrimusClass IIb
USK050866CENTRION 500 C-ARM SYSTEM2005-04-27

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