PSM02
by Temra International Ltd Malta EUDAMED
Ref PSM02 EMDN T020604
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | NumberPP11451PSM0210 | Date11 Oct 2023 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Temra Mask Dual PSM02 FFP2 NR IIR med Maske
- Model / Reference
- PSM02
- Primary DI / UDI-DI
- 111727333452
- Basic UDI-DI
- PP11451PSM0210
- Direct Marketing DI
- 111727333452
- EMDN Code
- T020604 Medical use face masks, type ii and iir
- Device Class
- Class I
- Market of Registration
- Germany
Manufacturer details
- EUDAMED SRN
- MT-MF-000001253
Other devices from Temra International 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 26c93a76-5f6f-4aa2-8560-7780c3f9fef6