Identity
- Device Name
- IIR Face Masks - MR Safe EUDAMED
- Model / Reference
- MRSIIR2A EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05057326002732 EUDAMED
- Basic UDI-DI
- 5057326FACEMASKIIR2P EUDAMED
- EMDN Code
- T020604 MEDICAL USE FACE MASKS, TYPE II AND IIR EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Ireland 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
IIR Face Masks - MR Safe by W S R Medical Solutions 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 | 5057326FACEMASKIIR2P | Class I | Active |
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Manufacturer
- Manufacturer
- WSR Medical Solutions Ltd
- EUDAMED SRN
- GB-MF-000017973
- Authorised Representative
- Eurolink Europe Compliance Limited IE-AR-000002852
Sources (1)
- EUDAMED 9054cf0c-5095-40ce-a944-e044fdd64906 61 fields · synced Jun 18, 2026