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Sterile X-ray Detectable Gauze Balls
EUDAMEDClass IIa (EU MDR)
Ref 011105Model 1cm、2cm、3cm、4cm
Identity
- Trade Name
- Sterile X-ray Detectable Gauze Balls EUDAMED
- Device Name
- Sterile X-ray Detectable Gauze Balls 消毒带X线纱布球 EUDAMED
- Model / Reference
- 1cm、2cm、3cm、4cm EUDAMED011105 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970233782384 EUDAMED
- Basic UDI-DI
- 697023378stgauzeBalls-XJE EUDAMED
- Direct Marketing DI
- 16970233782381 EUDAMED
- EMDN Code
- M0201020201 COTTON GAUZES, FOLDED, WITH X-RAY DETECTABLE THREAD, STERILE EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- France 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
Sterile X-ray Detectable Gauze Balls by Hubei V-Medical 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 | 697023378stgauzeBalls-XJE | Class IIa | Active |
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Manufacturer
- Manufacturer
- Hubei V-Medical Products Co., Ltd.
- EUDAMED SRN
- CN-MF-000011268
- Authorised Representative
- RAFFIN MEDICAL FR-AR-000004632
Sources (1)
- EUDAMED 061e9170-d587-45da-9ebd-f4f2536f8f60 61 fields · synced Oct 7, 2026