Positive Expiratory Pressure (PEP) Therapy device
by Intersurgical Ltd 9 variants
Ref 8020045
Active
CE MDR
Valid until
Not listed
FDA recalls
Not applicable
Documents
None, self-declared
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number05030267PEPTHERER 05030267160389 | Date17 Oct 2024 | StatusActive |
Certificates
No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Positive Expiratory Pressure (PEP) Therapy device
- Model / Reference
- 8020045
- Primary DI / UDI-DI
- 05030267160389
- Basic UDI-DI
- 05030267PEPTHERER
- EMDN Code
- Z12159009 Equipment for removal of secretions
- Device Class
- Class I
- EU market of registration
- Sweden
Manufacturer details
- EUDAMED SRN
- GB-MF-000004798
- Authorised representative
- UAB Intersurgical LT-AR-000003907
Other devices from Intersurgical Ltd
Properties
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