Identity
- Device Name
- SURGICAL FACE MASK EUDAMED
- Model / Reference
- IIR EUDAMEDIIR 17.5x9.5cm EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974409690107 EUDAMED
- Basic UDI-DI
- 697440969FaceMaskLQ 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
Surgical Face Mask by Mediwish 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 | 697440969FaceMaskLQ | Class I | Active |
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Manufacturer
- Manufacturer
- Mediwish Co., Ltd
- EUDAMED SRN
- CN-MF-000008849
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED e744e1fe-72e2-4093-a286-f9ffca5c39a7 61 fields · synced Jul 24, 2026