Identity
- Device Name
- Osteotec SFI Sizer EUDAMED
- Model / Reference
- Osteotec SFI Sizer EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060183095809 EUDAMED
- Basic UDI-DI
- 5060183090025Q EUDAMED
- EMDN Code
- P090480 HAND PROSTHESES - ACCESSORIES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Ireland EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
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 Sizer by Osteotec Limited — Class IIa — 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 | 5060183090025Q | Class IIa | 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 a9103610-d14b-4316-890b-a340c0b106c3 61 fields · synced Aug 1, 2026