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Lexer bone osteotome 25mm
EUDAMEDClass I (EU MDR)
Ref Bi8-842Model 8961103943781
Identity
- Trade Name
- Lexer bone osteotome 25mm EUDAMED
- Device Name
- Lexer bone osteotome 25mm EUDAMED
- Model / Reference
- 8961103943781 EUDAMEDBi8-842 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08961103943781 EUDAMED
- Basic UDI-DI
- 896110394Bi8-842FL EUDAMED
- EMDN Code
- L090401 ORTHOPAEDIC SURGERY OSTEOTOMES, REUSABLE EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Spain 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
Lexer bone osteotome 25mm by Battan International — 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 | 896110394Bi8-842FL | Class I | Active |
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Manufacturer
- Manufacturer
- Battan International
- EUDAMED SRN
- PK-MF-000043557
- Authorised Representative
- KHANG BAO INTERNATIONAL KFT HU-AR-000034102
Sources (1)
- EUDAMED 9d63ff42-62ce-4f96-a841-97b695d9f425 61 fields · synced Jun 17, 2026