Identity
- Trade Name
- Luer bone rongeur 15cm EUDAMED
- Device Name
- Luer bone rongeur 15cm EUDAMED
- Model / Reference
- 8961103944344 EUDAMEDBi8-438 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08961103944344 EUDAMED
- Basic UDI-DI
- 896110394Bi8-438F9 EUDAMED
- EMDN Code
- L090901 BONE CUTTERS, 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
Luer bone rongeur 15cm 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 | 896110394Bi8-438F9 | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Battan International
- EUDAMED SRN
- PK-MF-000043557
- Authorised Representative
- KHANG BAO INTERNATIONAL KFT HU-AR-000034102
Sources (1)
- EUDAMED f7fd5622-8cf2-4ed7-abc6-5e9908031b98 61 fields · synced Jun 19, 2026