Surgical mask
by Wellmien Healthcare Tech. (Suzhou) Co., Ltd. China EUDAMED
Ref TypeIIRModel TypeIIR,TypeII
EMDN T020604
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number697457045SM001KT | Date12 Mar 2026 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/MDR Active
Specification
- Model / Reference
- TypeIIR, TypeII
- Primary DI / UDI-DI
- 06974570450449
- Basic UDI-DI
- 697457045SM001KT
- EMDN Code
- T020604 Medical use face masks, type ii and iir
- Device Class
- Class I
- Market of Registration
- Austria
Manufacturer details
- EUDAMED SRN
- CN-MF-000010365
- Authorised representative
- SUNGO Europe B.V. NL-AR-000000247
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Properties & raw data
Show properties, registry sources and raw records
Other properties (13)
- Sterile: No
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No
Sources (1)
- EUDAMED a7f9fc08-0dac-4a20-ba5e-a6bf7fc51ba9