54060TVM
by FIAB S.p.A. Italy EUDAMED
Ref 54060TVMModel MYOPACE epimyocardial pacing wires for temporary cardiac stimulation
EMDN C020299
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number803300326011000005K5 | Date17 Jun 2026 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/MDR Active
Certificates
- MDR 747885 Supplemented
Technical documentation EU MDR
- Notified body
- Notified body 2797
- Issued
- 23 Jul 2026
- Expires
- 26 Mar 2030
- Reason
- Change approved
Specification
- Model / Reference
- MYOPACE epimyocardial pacing wires for temporary cardiac stimulation, 54060TVM
- Primary DI / UDI-DI
- 08054242446012
- Basic UDI-DI
- 803300326011000005K5
- EMDN Code
- C020299 Cardiac temporary stimulation devices (with or without active substances) - other
- Device Class
- Class III
- Market of Registration
- Italy
Manufacturer details
- EUDAMED SRN
- IT-MF-000005988
Other devices from FIAB S.p.A.
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 08054242446012|803300326011000005K5