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Panep
EUDAMEDClass IIa (EU MDR)
Ref 28000Model Gauze Balls with X-ray detectable, Gauze Sponges/Swabs with X-ray detectable
Identity
- Trade Name
- PANEP EUDAMED
- Device Name
- Gauze Sponges/Swabs/Balls with X-ray detectable EUDAMED
- Model / Reference
- Gauze Balls with X-ray detectable, Gauze Sponges/Swabs with X-ray detectable EUDAMED28000 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06947872507210 EUDAMED
- Basic UDI-DI
- 69478725IIa9V EUDAMED
- Direct Marketing DI
- 06947872507210 EUDAMED
- EMDN Code
- M0201020201 COTTON GAUZES, FOLDED, WITH X-RAY DETECTABLE THREAD, STERILE EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Czechia EUDAMED
Clinical & Handling
Sterile
Yes
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 | 69478725IIa9V | 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 69fb17a8-c82e-453e-94fd-4ed5dae55912 61 fields · synced Oct 6, 2026