Lefaxan Protect
by Devintec Sagl EUDAMED
Active
Ref C12B02E015, C12B02E030, F12B02E015
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | NumberIT326645 | Date18 Mar 2025 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/MDR Active
Certificates
- IT326645 Supplemented
Technical documentation EU MDR
- Notified body
- BUREAU VERITAS ITALIA S.P.A. 1370
- Issued
- 18 Mar 2025
- Expires
- 7 Sep 2028
- Reason
- Add device or group
Specification
- Device Name
- Sectacol
- Model / Reference
- C12B02E015, C12B02E030, F12B02E015
- Primary DI / UDI-DI
- 07649993626229, 07649993626236, 07649993626250
- Basic UDI-DI
- 7649993626FT42306VN
- Direct Marketing DI
- 076499936262290764999362623607649993626250
- EMDN Code
- G0401 Orally administered devices for the therapy of gastro-intestinal disorders
- Device Class
- Class III
- Market of Registration
- Germany
Manufacturer details
- EUDAMED SRN
- CH-MF-000020271
- Authorised representative
- DEVINTEC HEALTH S.L. ES-AR-000020256
Other devices from Devintec Sagl
Properties
Show 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