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Gauze Sponges without X-ray, Gauze Swabs (sponges), Gauze Pad without X-ray
EUDAMEDClass I (EU MDR)
Ref 001Model without X-ray
Identity
- Trade Name
- Gauze Sponges without X-ray, Gauze Swabs (sponges), Gauze Pad without X-ray EUDAMED
- Device Name
- Gauze Sponges/Swabs/Balls without X-ray sterile EUDAMED
- Model / Reference
- without X-ray EUDAMED001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06947872504035 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
- Spain 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 without X-ray, Gauze Swabs (sponges), Gauze Pad without X-ray by Shaoxing Gangfeng Hospital Products Co., Ltd. — Class I — MDR — listed in EUDAMED
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 a699225b-9e1f-4ca5-bbc1-1cee0b2f2e79 61 fields · synced Oct 6, 2026