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Lexer bone osteotome 10mm
EUDAMEDClass I (EU MDR)
Ref Bi8-845Model 8961103943811
Identity
- Trade Name
- Lexer bone osteotome 10mm EUDAMED
- Device Name
- Lexer bone osteotome 10mm EUDAMED
- Model / Reference
- 8961103943811 EUDAMEDBi8-845 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08961103943811 EUDAMED
- Basic UDI-DI
- 896110394Bi8-845FS 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 10mm 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 | 896110394Bi8-845FS | 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 d63f184e-53cb-4ded-a0c6-0116c341338d 61 fields · synced Jun 19, 2026