Identity
- Trade Name
- Gelpi 11cm EUDAMED
- Device Name
- Gelpi 11cm EUDAMED
- Model / Reference
- 10-2902-11 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08961103284266 EUDAMED
- Basic UDI-DI
- 89611032810-2902-11BL EUDAMED
- EMDN Code
- L03140199 SPREADERS AND RETRACTORS FOR GENERAL SURGERY, REUSABLE - OTHER 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
Category: Hand-held surgical retractor, reusable
Gelpi 11cm by Nadeem Surgical Corporation (Pvt.) Ltd. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | 89611032810-2902-11BL | 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 e306cabb-41f4-4237-be72-fef8d85ef3bf 61 fields · synced Oct 6, 2026