Identity
- Trade Name
- PANEP EUDAMED
- Device Name
- Gauze Sponges/Swabs/Balls without X-ray sterile EUDAMED
- Model / Reference
- without X-ray EUDAMED37002 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06947872506770 EUDAMED
- Basic UDI-DI
- 69478725I*SBW8 EUDAMED
- Direct Marketing DI
- 06947872506770 EUDAMED
- EMDN Code
- M0201020101 COTTON GAUZES, FOLDED, WITHOUT X-RAY DETECTABLE THREAD, STERILE EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Czechia EUDAMED
Clinical & Handling
Sterile
No
EUDAMEDEUDAMED
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 I — 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 | 69478725I*SBW8 | Class I | 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 (2)
- EUDAMED 31f7b6a5-4d7d-4f12-a525-cd629297bf98 61 fields · synced Oct 7, 2026
- EUDAMED b71f31e0-1979-497d-a230-af501d4b4fb3 61 fields · synced Oct 7, 2026