InsoleX BT
by Cometa S.r.l. Italy EUDAMED
Ref CINSBModel InsoleX
EMDN Z12062602
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number++G082CINSC2 | Date28 Mar 2025 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/MDR Active
Specification
- Model / Reference
- InsoleX, CINSB
- Primary DI / UDI-DI
- +G082CINSB0
- Basic UDI-DI
- ++G082CINSC2
- EMDN Code
- Z12062602 Sensor-based insoles
- Device Class
- Class I
- Market of Registration
- Denmark
Manufacturer details
- EUDAMED SRN
- IT-MF-000012630
Other devices from Cometa S.r.l.
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 59d6b25a-d7d8-41b5-837a-e3fbc7d1b9e2