Identity
- Device Name
- Disposable medical face mask EUDAMED
- Model / Reference
- MDR EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973461780306 EUDAMED06973461780269 EUDAMED
- Basic UDI-DI
- 697346178K31TKP EUDAMED
- EMDN Code
- T020699 MEDICAL USE FACE MASKS (EXCLUDING PERSONAL PROTECTIVE EQUIPMENT - PPE) - OTHER EUDAMEDR030199 RESPIRATORY MASKS - OTHER EUDAMED
Classification
- Device Class
- Class IIa 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
Disposable medical face mask by X&Y Industrial Co., Ltd. — Class IIa — 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 | 697346178K31TKP | Class IIa | Active |
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Manufacturer
- Manufacturer
- X&Y Industrial Co., Ltd.
- EUDAMED SRN
- CN-MF-000026048
- Authorised Representative
- RIOMAVIX SOCIEDAD LIMITADA ES-AR-000001202
Sources (2)
- EUDAMED 2de2efbb-f2c7-4397-a8d6-317d49bdf898 61 fields · synced Jul 28, 2026
- EUDAMED 39f08560-12b5-4481-a420-554e4299f74d 61 fields · synced May 17, 2026