OsteoSys Co., Ltd.

South Korea KR-MF-000010177 Last updated 21 Oct 2026

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Devices: 8
Registries: EUDAMEDFDA 510(k)
FDA recalls: 0

Catalogue8

DEXXUM T Quantum Ref DEXXUM T Quantum

Class IIb EUDAMED Active
iNSiGHT C510 Ref iNSiGHT C510

Class IIb EUDAMED Active
Quantum Pro Ref Quantum Pro

Class IIb EUDAMED Active
Dexxum T Ref DEXXUM T

Class IIb EUDAMED Active
Centrion 500 C-Arm System Ref K050866

Class II FDA 510(k) Active
BeeTLe Ref BeeTLe

Class IIa EUDAMED Active
Sonost-2000 Ref SONOST-2000

Class IIa EUDAMED Active
Sonost-3000 Ref SONOST-3000

Class IIa EUDAMED Active

EUDAMED certificates1

Held under this manufacturer's EUDAMED registration, grouped by notified body; in force first, then by expiry.

DNV Product Assurance AS 2460 1 certificate

C591229 Issued

Quality management system EU MDR

Issued
21 Aug 2024

Expires
21 Aug 2029

Authorised representatives

CMC Medical Devices & Drugs SL ES

Notified bodies

DNV Product Assurance AS 2460

Information

Country: South Korea
Address: 26, Digital-ro, Guro-gu, South Korea
Website: www.osteosys.com/englsh/ This address returned "not found" when we last checked — the site may have moved.Last checked 18 Oct 2026.
Email: [email protected]
PRRC contact: Yu-jin Jung
EUDAMED SRN: KR-MF-000010177