DOLCE pediatric mask, butterfly type
by Too Dolce Kazakhstan EUDAMED
Ref DMFM001
EMDN T020603
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number487024301DMFM0015M | Date29 Apr 2023 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- DOLCE Medical Face Mask
- Model / Reference
- DMFM001
- Primary DI / UDI-DI
- 04870243010274, 04870243010281, 04870243010298
- Basic UDI-DI
- 487024301DMFM0015M
- Direct Marketing DI
- 048702430102740487024301028104870243010298
- EMDN Code
- T020603 Medical use face masks, type i (not for healthcare professionals)
- Device Class
- Class I
- Market of Registration
- Germany
Manufacturer details
- EUDAMED SRN
- KZ-MF-000031761
- Authorised representative
- I.S. Med Dev Compliance Ltd CY-AR-000031627
Other devices from Too Dolce
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 (3)
- EUDAMED 7d73fed3-7a62-464e-b133-28f77ea64b22
- EUDAMED ebed0f36-7cd1-4752-aafe-fe744e3e03b7
- EUDAMED 21605dd2-3655-4d8f-b6a1-fbe2b172ee49