Identity
- Device Name
- face masks EUDAMED
- Model / Reference
- TYPE IIR EUDAMED090101 EUDAMED1000-ELB/B-IIR EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06970237520876 EUDAMED06970237520975 EUDAMED
- Basic UDI-DI
- 697023752NWFaceMasks5Y EUDAMED
- EMDN Code
- T020604 MEDICAL USE FACE MASKS, TYPE II AND IIR EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- France 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 masks by Xiantao Rayxin Medical Products 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 | 697023752NWFaceMasks5Y | Class I | Active |
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Manufacturer
- Manufacturer
- Xiantao Rayxin Medical Products Co. Ltd.
- EUDAMED SRN
- CN-MF-000000787
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (2)
- EUDAMED 70a69833-2e83-43f0-aace-e0aa0d404e09 61 fields · synced Oct 6, 2026
- EUDAMED 155e898c-c06a-4642-9817-f28037aa3264 61 fields · synced Jul 14, 2026