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Lexer bone osteotome 30mm
EUDAMEDClass I (EU MDR)
Ref Bi8-843Model 8961103943798Ref Bi8-849
Identity
- Trade Name
- Lexer bone osteotome 30mm EUDAMED
- Device Name
- Lexer bone osteotome 30mm EUDAMED
- Model / Reference
- 8961103943798 EUDAMEDBi8-843 EUDAMEDBi8-849 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08961103943798 EUDAMED08961103943859 EUDAMED
- Basic UDI-DI
- 896110394Bi8-843FN EUDAMED896110394Bi8-849G2 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 30mm 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 | 896110394Bi8-843FN | 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 (2)
- EUDAMED 2b18c8b8-0037-4847-87db-1ff48500dfcd 61 fields · synced Jul 22, 2026
- EUDAMED 2a45d151-114a-4e94-8d7e-9f48919e4651 61 fields · synced May 16, 2026