Identity
- Trade Name
- OSTEOTRANS EUDAMED
- Device Name
- OSTEOTRANS-OT EUDAMED
- Model / Reference
- OR4327 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04550052844153 EUDAMED
- Basic UDI-DI
- B-04550052844153 EUDAMED
- EMDN Code
- P0999 ORTHOPAEDIC PROSTHESES, OSTEOSYNTHESIS DEVICES, DEVICES FOR TENDON AND LIGAMENT SYNTHESIS - OTHER EUDAMED
Classification
- Device Class
- Class III EUDAMED
- Market of Registration
- Türkiye EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
Yes
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
The OSTEOTRANS device is a cutting-edge orthopedic solution for the treatment of osteotransplantation. Developed by Emergo Europe B.V., this device offers a comprehensive approach to bone repair, utilizing advanced technologies and materials to ensure optimal outcomes.
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union No Longer Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-04550052844153 | Class III | No Longer Active |
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Manufacturer
- Manufacturer
- Teijin Medical Technologies Co., Ltd.
- EUDAMED SRN
- JP-MF-000032429
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (1)
- EUDAMED 026431d1-9d99-4430-aeef-a8855aea2e4b 61 fields · synced Jul 12, 2026