CPAP Mask Liners
by RespiraSource, OPC Philippines EUDAMED
Ref B09R5STPRG
EMDN Z12030102
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number0850040313ML6S | Date15 Jun 2025 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/MDR Active
Specification
- Model / Reference
- B09R5STPRG
- Primary DI / UDI-DI
- 00850038100193
- Basic UDI-DI
- 0850040313ML6S
- EMDN Code
- Z12030102 Continuous positive pressure equipment
- Device Class
- Class I
- Market of Registration
- Germany
Manufacturer details
- EUDAMED SRN
- PH-MF-000013799
- Authorised representative
- Obelis s.a. BE-AR-000000106
Other devices from RespiraSource, OPC
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 0dfb309e-c25a-4a23-aecc-c2109afd67e0