Era Medical
by New Style Bulgaria EUDAMED
Ref 10770
EMDN T020604
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number3800910107705J | Date31 Mar 2022 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Blue Mask for kids
- Model / Reference
- 10770
- Primary DI / UDI-DI
- 03800910107755
- Basic UDI-DI
- 3800910107705J
- Direct Marketing DI
- 03800910107755
- EMDN Code
- T020604 Medical use face masks, type ii and iir
- Device Class
- Class I
- Market of Registration
- Bulgaria
Manufacturer details
- EUDAMED SRN
- BG-MF-000022200
Other devices from New Style
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 f78ed8e7-26fc-4df1-ab21-7d96cf121172