Identity
- Trade Name
- Leksell Rongeur, curved, 8mm, 23cm EUDAMED
- Device Name
- Leksell Rongeur, curved, 8mm, 23cm EUDAMED
- Model / Reference
- 13-3664-04A EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08961103284570 EUDAMED
- Basic UDI-DI
- 89611032813-3664-04ALY EUDAMED
- EMDN Code
- L091302 BONE RONGEURS, REUSABLE EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany 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
Leksell Rongeur, curved, 8mm, 23cm by Nadeem Surgical Corporation (Pvt.) Ltd. — 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 | 89611032813-3664-04ALY | Class I | Active |
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Manufacturer
- Manufacturer
- Nadeem Surgical Corporation (Pvt.) Ltd.
- EUDAMED SRN
- PK-MF-000036227
- Authorised Representative
- KHANG BAO INTERNATIONAL KFT HU-AR-000034102
Sources (1)
- EUDAMED 8ea2af8a-a7d3-475a-81d6-296972548c03 61 fields · synced Oct 9, 2026