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Gauze Sponges/Swabs without X-ray
EUDAMEDClass I (EU MDR)
Ref 0131Model without X-ray
Identity
- Trade Name
- Gauze Sponges/Swabs without X-ray EUDAMED
- Device Name
- Gauze Sponges/Swabs/Balls without X-ray sterile EUDAMED
- Model / Reference
- without X-ray EUDAMED0131 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06947872502291 EUDAMED
- Basic UDI-DI
- 69478725I*SBW8 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
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
Gauze Sponges/Swabs without X-ray 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 (1)
- EUDAMED 40b0fc65-0b75-4b14-a9a1-c4ee70c63c4e 61 fields · synced Oct 10, 2026