Identity
- Device Name
- Osteotec SFI Instruments EUDAMED
- Model / Reference
- OSTF-Ins EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060183095793 EUDAMED
- Basic UDI-DI
- 5060183090035S EUDAMED
- Direct Marketing DI
- 05060183095793 EUDAMED
- EMDN Code
- P090480 HAND PROSTHESES - ACCESSORIES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Ireland 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
Osteotec SFI Instruments by Osteotec Limited — 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 | 5060183090035S | Class I | Active |
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Manufacturer
- Manufacturer
- Osteotec Limited
- EUDAMED SRN
- GB-MF-000019832
- Authorised Representative
- Osteotec Ireland Limited IE-AR-000037895
Sources (1)
- EUDAMED 25450be3-d77e-469b-9215-83b7b128eb0c 61 fields · synced Jun 19, 2026