Omnitex
by Sharon Services (UK) Ltd. United Kingdom EUDAMED
Ref MK-OX-50DUModel Type IIR Surgical Face Masks
EMDN T020604
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number506064521SUFM018U | Date22 May 2025 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Type IIR Surgical Face Masks
- Model / Reference
- Type IIR Surgical Face Masks, MK-OX-50DU
- Primary DI / UDI-DI
- 05060645211068
- Basic UDI-DI
- 506064521SUFM018U
- Direct Marketing DI
- 05060645211068
- EMDN Code
- T020604 Medical use face masks, type ii and iir
- Device Class
- Class I
- Market of Registration
- Netherlands
Manufacturer details
- EUDAMED SRN
- UK-MF-000047592
- Authorised representative
- Sharon Services Europe B.V. NL-AR-000047497
Other devices from Sharon Services (UK) Ltd.
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 cbe6ba99-3474-427d-b17d-3e5901323f98