Identity
- Trade Name
- Osteotome 13,5cm/5¼", 4,0mm wide EUDAMED
- Device Name
- Osteotome 13,5cm/5¼", 4,0mm wide EUDAMED
- Model / Reference
- 3260204 EUDAMED
Identifiers
- Primary DI / UDI-DI
- G47232602040 EUDAMED
- Basic UDI-DI
- ++G4723260204SZ EUDAMED
- EMDN Code
- L090401 ORTHOPAEDIC SURGERY OSTEOTOMES, REUSABLE EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany 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
Osteotome 13, 5cm/5¼", 4, 0mm wide by HB Meditech (Pvt) 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 | ++G4723260204SZ | Class I | Active |
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Manufacturer
- Manufacturer
- HB Meditech (Pvt) Limited
- EUDAMED SRN
- PK-MF-000024590
- Authorised Representative
- ANTEX MEDI SOLUTION DE-AR-000008078
Sources (1)
- EUDAMED cd495d6c-a123-485d-9b64-8cd85f3abb0c 61 fields · synced Jul 31, 2026