Identity
- Device Name
- Disposable Medical Face Mask EUDAMED
- Model / Reference
- with earloop EUDAMED
Identifiers
- Primary DI / UDI-DI
- 16974321445011 EUDAMED
- Basic UDI-DI
- 697432144FM001A5 EUDAMED
- Unit of Use DI
- 06974321445014 EUDAMED
- EMDN Code
- T020604 MEDICAL USE FACE MASKS, TYPE II AND IIR EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
No
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
Disposable Medical Face Mask by Jiujiang HuaDa Medical Dressing 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 | 697432144FM001A5 | Class I | Active |
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Manufacturer
- Manufacturer
- Jiujiang HuaDa Medical Dressing Co., Ltd.
- EUDAMED SRN
- CN-MF-000024512
- Authorised Representative
- MedPath GmbH DE-AR-000000087
Sources (1)
- EUDAMED 21a021ca-a7f2-4022-95f2-e2f2d1d41e7c 61 fields · synced Jun 18, 2026