Identity
- Trade Name
- Retainer EUDAMED
- Device Name
- Orthopaedic and traumatological surgery instruments, reusable - other EUDAMED
- Model / Reference
- OTNI 1312 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08720629959337 EUDAMED
- Basic UDI-DI
- 87193242510002U9 EUDAMED
- Direct Marketing DI
- 08720629959337 EUDAMED
- EMDN Code
- L0999 ORTHOPAEDIC AND TRAUMATOLOGICAL SURGERY INSTRUMENTS, REUSABLE - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Retainer by BAAT Medical Products B.V. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 87193242510002U9 | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- BAAT Medical Products B.V.
- EUDAMED SRN
- NL-MF-000001569
Sources (1)
- EUDAMED 343becf8-62c0-4c15-b641-72cc93270376 61 fields · synced Jun 17, 2026