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Lexer bone gouge 15mm
EUDAMEDClass I (EU MDR)
Ref Bi8-821Model 8961103943682Ref Bi8-853
Identity
- Trade Name
- Lexer bone gouge 15mm EUDAMED
- Device Name
- Lexer bone gouge 15mm EUDAMED
- Model / Reference
- 8961103943682 EUDAMEDBi8-821 EUDAMEDBi8-853 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08961103943682 EUDAMED08961103943880 EUDAMED
- Basic UDI-DI
- 896110394Bi8-821FC EUDAMED896110394Bi8-853FR EUDAMED
- EMDN Code
- L090403 ORTHOPAEDIC SURGERY GOUGES, 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 gouge 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 | 896110394Bi8-821FC | 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 08e1a616-f8f8-4581-9b01-8d0d871773d5 61 fields · synced Jul 9, 2026
- EUDAMED 1b4c2429-a324-4d07-8174-b9cf631caee8 61 fields · synced May 17, 2026