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Lexer bone osteotome 15mm
EUDAMEDClass I (EU MDR)
Ref Bi8-846Model 8961103943828Ref Bi8-840Model 8961103943767
Identity
- Trade Name
- Lexer bone osteotome 15mm EUDAMED
- Device Name
- Lexer bone osteotome 15mm EUDAMED
- Model / Reference
- 8961103943828 EUDAMEDBi8-846 EUDAMED8961103943767 EUDAMEDBi8-840 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08961103943828 EUDAMED08961103943767 EUDAMED
- Basic UDI-DI
- 896110394Bi8-846FU EUDAMED896110394Bi8-840FG 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 15mm 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 | 896110394Bi8-846FU | 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 86d7de29-257e-471b-800f-75a5401510d5 61 fields · synced Jul 9, 2026
- EUDAMED 6a9d0cd9-8338-4f76-8025-d6b1799b3151 61 fields · synced May 18, 2026