← Back to catalogue
Protective Face Masks
EUDAMEDClass I (EU MDR)
Ref 1157795Model Ear-hanging type
Identity
- Trade Name
- PROTECTIVE FACE MASKS EUDAMED
- Device Name
- Disposable Medical Face Mask EUDAMED
- Model / Reference
- Ear-hanging type EUDAMED1157795 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 16941762601863 EUDAMED
- Basic UDI-DI
- 69417626013V4 EUDAMED
- EMDN Code
- T020603,T020604 EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany 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
Protective Face Masks by Changzhou Hualian Health 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 | 69417626013V4 | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
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 48737d5f-fc68-4bc8-a5f4-0bd24e8e564e 61 fields · synced Oct 6, 2026