Aerobika
by Trudell Medical International FDA registration: Canada EUDAMED
Ref 110501/11050191010Model 110501 EMDN R9099
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number762860OPEP1G4 | Date30 Mar 2022 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Aerobika* Oscillating Positive Expiratory Pressure Device
- Model / Reference
- 110501, 110501/11050191010
- Primary DI / UDI-DI
- 00762860000681
- Basic UDI-DI
- 762860OPEP1G4
- EMDN Code
- R9099 Respiratory and anaesthesia devices - other
- Device Class
- Class I
- Market of Registration
- Türkiye
Manufacturer details
- EUDAMED SRN
- CA-MF-000009860
- Authorised representative
- Emergo Europe B.V. NL-AR-000000116
Other devices from Trudell Medical International
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 00762860000681|762860OPEP1G4