Identity
- Trade Name
- PANEP EUDAMED
- Device Name
- Non-woven Lap Sponges without X-ray EUDAMED
- Model / Reference
- without X-ray EUDAMED03100 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06947872507333 EUDAMED
- Basic UDI-DI
- 69478725WFBFBDIIa3T EUDAMED
- Direct Marketing DI
- 06947872507333 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 b8703752-55c1-4946-9b9a-649eac621165 61 fields · synced Oct 7, 2026