C2 Cryoablation(TM) System catheter
by Pentax Medical a Division of Pentax of America Inc United States EUDAMED
Ref FG-1022Model FG-1027 EMDN G0301010101
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number4961333020017XZ | Date2 Oct 2024 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- C2 Cryoballoon (TM) System Catheter
- Model / Reference
- FG-1027, FG-1022
- Primary DI / UDI-DI
- 00854924006224
- Basic UDI-DI
- 4961333020017XZ
- EMDN Code
- G0301010101 Oesophageal balloon catheters, low pressure
- Device Class
- Class IIa
- Market of Registration
- Germany
Manufacturer details
- EUDAMED SRN
- US-MF-000042816
- Authorised representative
- PENTAX Europe GmbH DE-AR-000000006
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Properties & raw data
Show properties, registry sources and raw records
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
Sources (1)
- EUDAMED bd6c4274-82b4-4a91-9b2a-3671ade79af4