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Mini lexer bone gouge 8mm
EUDAMEDClass I (EU MDR)
Ref Bi8-829Model 8961103943712
Identity
- Trade Name
- Mini lexer bone gouge 8mm EUDAMED
- Device Name
- Mini lexer bone gouge 8mm EUDAMED
- Model / Reference
- 8961103943712 EUDAMEDBi8-829 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08961103943712 EUDAMED
- Basic UDI-DI
- 896110394Bi8-829FU 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
Mini lexer bone gouge 8mm 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 | 896110394Bi8-829FU | 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 75fdd074-cbd5-41d5-8d57-47238eafaee8 61 fields · synced Jul 9, 2026