Identity
- Trade Name
- PANEP EUDAMED
- Device Name
- Non-woven Lap Sponges without X-ray EUDAMED
- Model / Reference
- without X-ray EUDAMED91005.R EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06947872503595 EUDAMED
- Basic UDI-DI
- 69478725WFBFBDIIa3T EUDAMED
- Direct Marketing DI
- 06947872503595 EUDAMED
- EMDN Code
- M0202020202 NON-WOVEN LAPAROTOMY GAUZES, WITH X-RAY DETECTABLE THREAD, NON-STERILE EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Czechia EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
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
Panep by Shaoxing Gangfeng Hospital Products Co., Ltd. — Class IIa — 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 | 69478725WFBFBDIIa3T | Class IIa | Active |
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Manufacturer
- Manufacturer
- Shaoxing Gangfeng Hospital Products Co., Ltd.
- EUDAMED SRN
- CN-MF-000008133
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED ed029a83-8447-4d18-b7bf-3e5b3fd8ebc6 61 fields · synced Oct 10, 2026