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Gauze Compress 5X5cm
EUDAMEDClass I (EU MDR)
Ref Q8365Model 5*5cm、7.5*7.5cm、8*10cm、10*10cm、15*15cm、10*20cm
Identity
- Trade Name
- Gauze Compress 5X5cm EUDAMED
- Device Name
- Sterile Gauze Swabs 消毒纱布片 EUDAMED
- Model / Reference
- 5*5cm、7.5*7.5cm、8*10cm、10*10cm、15*15cm、10*20cm EUDAMEDQ8365 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942013210141 EUDAMED
- Basic UDI-DI
- 697023378stgauzeSwabs9G EUDAMED
- Direct Marketing DI
- 06942013210141 EUDAMED
- EMDN Code
- M0299 GAUZES - OTHER EUDAMED
Classification
- Device Class
- Class I 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
Gauze Compress 5X5cm by Hubei V-Medical 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 | 697023378stgauzeSwabs9G | Class I | 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 bb8ba0ff-4187-456f-b7a3-6e726fa52440 61 fields · synced Oct 6, 2026