Identity
- Trade Name
- OSTEOTRANS EUDAMED
- Device Name
- OSTEOTRANS-MX EUDAMED
- Model / Reference
- OPS205HE EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04550052843613 EUDAMED
- Basic UDI-DI
- B-04550052843613 EUDAMED
- EMDN Code
- P09120699 BONE FIXATION SCREWS, TENDON AND LIGAMENT SYNTHESIS SCREWS - OTHER EUDAMED
Classification
- Device Class
- Class III EUDAMED
- Market of Registration
- Spain 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
Osteotrans by Teijin Medical Technologies Co., Ltd. — Class III — MDD — listed in EUDAMED — regulatory data on deviCERTS
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European Union No Longer Active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| EUDAMED | European Union | CE/MDD | B-04550052843613 | Class III | No Longer Active |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 a050665c-6afd-4b11-b8df-1b4811469073 61 fields · synced Jun 18, 2026