Identity
- Trade Name
- Surgical mask EUDAMED
- Device Name
- Surgical mask EUDAMED
- Model / Reference
- Ref EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06972841173196 EUDAMED06972841173509 EUDAMED
- Basic UDI-DI
- 697284117MEII115QK EUDAMED
- EMDN Code
- T020604 MEDICAL USE FACE MASKS, TYPE II AND IIR EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Bulgaria EUDAMEDGermany 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
Surgical 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 | 697284117MEII115QK | 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 ee1c1434-79dc-41a1-9d27-008dccffe51b 61 fields · synced Oct 6, 2026
- EUDAMED 51f9f1f1-47f5-4e18-9219-16b420aacbb2 61 fields · synced Jun 19, 2026
- EUDAMED e3bb0443-e993-4225-8dea-3a510991b718 61 fields · synced Jul 20, 2026