Identity
- Device Name
- Disposable Face Mask EUDAMEDFace Mask EUDAMED
- Model / Reference
- Ref EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06972841172335 EUDAMED06972841173202 EUDAMED
- Basic UDI-DI
- 697284117MEIIR1157D EUDAMED
- EMDN Code
- T020604 MEDICAL USE FACE MASKS, TYPE II AND IIR EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Belgium EUDAMEDBulgaria 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 Face Mask by Zhejiang Mediunion Healthcare Group 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 | 697284117MEIIR1157D | Class I | Active |
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Manufacturer
- Manufacturer
- Zhejiang Mediunion Healthcare Group Co., Ltd.
- EUDAMED SRN
- CN-MF-000026766
- Authorised Representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Sources (3)
- EUDAMED fb5f3969-7c2e-48ba-bda8-3aac4adc4a06 61 fields · synced Oct 6, 2026
- EUDAMED 473553f7-5aca-440a-9339-1f3b01058e86 61 fields · synced Jul 9, 2026
- EUDAMED 7b4a444c-4bf7-41a0-978b-e4652f5d41f7 61 fields · synced Aug 3, 2026