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Panep
EUDAMEDClass IIa (EU MDR)
Ref TP22/13/8vrModel Lap Sponges With X-ray detectable
Identity
- Trade Name
- PANEP EUDAMED
- Device Name
- Lap Sponges With X-ray detectable EUDAMED
- Model / Reference
- Lap Sponges With X-ray detectable EUDAMEDTP22/13/8vr EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06947872507524 EUDAMED
- Basic UDI-DI
- 69478725XFBDIIaCH EUDAMED
- Direct Marketing DI
- 06947872507524 EUDAMED
- EMDN Code
- M0201030202 LAPAROTOMY COTTON 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 | 69478725XFBDIIaCH | 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 b57307bd-aa85-43c2-a35e-d59545b0acc8 61 fields · synced Oct 8, 2026