C2 Cryoablation(TM) System catheter
by Pentax Medical a Division of Pentax of America Inc 4 variants
Ref FG-1021Model FG-1027
Active
CE MDR
Valid until
Not listed
FDA recalls
Not applicable
Documents
None linked in EUDAMED
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number4961333020017XZ 00854924006217 | Date2 Oct 2024 | StatusActive |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- C2 Cryoballoon (TM) System Catheter
- Model / Reference
- FG-1027, FG-1021
- Primary DI / UDI-DI
- 00854924006217
- Basic UDI-DI
- 4961333020017XZ
- EMDN Code
- G0301010101 Oesophageal balloon catheters, low pressure
- Device Class
- Class IIa
- EU market of registration
- Germany
Manufacturer details
- EUDAMED SRN
- US-MF-000042816
- Authorised representative
- PENTAX Europe GmbH DE-AR-000000006
Other devices from Pentax Medical a Division of Pentax of America Inc
See all devices from Pentax Medical a Division of Pentax of America Inc →
Properties
Other properties (12)
- 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