Identity
- Device Name
- face mask EUDAMED
- Model / Reference
- Flat-type: 17.5cm×9.5cm EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975382070108 EUDAMED
- Basic UDI-DI
- 697538207FM001F4 EUDAMED
- EMDN Code
- T020604 MEDICAL USE FACE MASKS, TYPE II AND IIR EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Austria 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
face mask by Xinyang Yihe Non-woven 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 | 697538207FM001F4 | Class I | Active |
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Manufacturer
- Manufacturer
- Xinyang Yihe Non-Woven Co., Ltd
- EUDAMED SRN
- CN-MF-000023918
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED 73d3e816-50dd-4707-be21-c089fb7b5623 61 fields · synced Jul 9, 2026