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Gauze Sponges with X-ray, X-ray detectable Gauze Swabs (sponges), Gauze Pad wit…
EUDAMEDClass IIa (EU MDR)
Ref 013Model Gauze Balls with X-ray detectable, Gauze Sponges/Swabs with X-ray detectable
Identity
- Trade Name
- Gauze Sponges with X-ray, X-ray detectable Gauze Swabs (sponges), Gauze Pad with X-ray 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 EUDAMED013 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06947872504622 EUDAMED
- Basic UDI-DI
- 69478725IIa9V EUDAMED
- EMDN Code
- M0201020201 COTTON GAUZES, FOLDED, WITH X-RAY DETECTABLE THREAD, STERILE EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany 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 with X-ray, X-ray detectable Gauze Swabs (sponges), Gauze Pad wit… by Shaoxing Gangfeng Hospital Products Co., Ltd. — Class IIa — MDR — listed…
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 93ddc2a3-0eb3-4dd4-a777-4c1e8c4f0399 61 fields · synced Oct 8, 2026