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Disposable Medical Face Mask
EUDAMEDClass I (EU MDR)
Ref 69417626013V4Model Type I, Type II, Type IIR
Identity
- Device Name
- Disposable Medical Face Mask EUDAMED
- Model / Reference
- Type I, Type II, Type IIR EUDAMED69417626013V4 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-69417626013V4AG EUDAMED
- Basic UDI-DI
- B-69417626013V4AG EUDAMED
- EMDN Code
- T020699 MEDICAL USE FACE MASKS (EXCLUDING PERSONAL PROTECTIVE EQUIPMENT - PPE) - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Disposable Medical Face Mask by Changzhou Hualian Health Dressing Co., Ltd — Class I — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-69417626013V4AG | Class I | Active |
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Manufacturer
- Manufacturer
- Changzhou Hualian Health Dressing Co., Ltd.
- EUDAMED SRN
- CN-MF-000021134
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED 52bbade8-acd3-4b39-ae62-036389b4aca7 61 fields · synced Oct 6, 2026