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OSSTEM IMPLANT Co., Ltd.

Manufacturer of medical devices registered in the European database in Haeundae-gu, Busan, South Korea.

Registration number (SRN)KR-MF-000020006
Short nameHaeundae Plant
RoleManufacturer
StatusActive
CountrySouth Korea
City48002 Haeundae-gu, Busan
AddressBansong-ro 513beon-gil, 66-16 48002 Haeundae-gu, Busan
Registered on2022-02-07

United States market access

FDA establishment register Registered with the U.S. FDA
Matched entryOSSTEM IMPLANT CO., LTD. (KR) · FDA 3031886796

Notified body certificates

CertificateStatusExpiryTypeBody
HZ 2292034-1supplemented2029-08-15Quality management systemNB 0197

⚠️ State of the register on 2026-08-20. EUDAMED shows only the current version of a certificate — earlier versions are not published, by the Commission or by anyone. A certificate shown as valid here may have changed since. For a legally binding check, consult EUDAMED directly.

The SRN is the registration number assigned by the European Commission. It has been mandatory since 28 May 2026 for any operator placing a medical device on the Union market. Contact details are published in the official register; we do not reproduce them here.

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