Refluzero
by Sofar Swiss SA Switzerland EUDAMED
Ref RZ-C04LModel MELT IN MOUTH TABLETS
EMDN G99
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number764015897GERDOFFSE | Date15 Oct 2025 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/MDR Active
Certificates
- CSQ0028250925 Supplemented
Quality management system EU MDR
- Notified body
- ISTITUTO SUPERIORE DI SANITA' 0373
- Issued
- 26 May 2025
- Expires
- 23 Apr 2030
- Reason
- Add device or group
- CVD0043250725 Supplemented
Technical documentation EU MDR
- Notified body
- ISTITUTO SUPERIORE DI SANITA' 0373
- Issued
- 14 May 2025
- Expires
- 23 Apr 2030
- Reason
- Change approved
Specification
- Model / Reference
- MELT IN MOUTH TABLETS, RZ-C04L
- Primary DI / UDI-DI
- 07640158970546, 07640158970515, 07640158970539
- Basic UDI-DI
- 764015897GERDOFFSE
- Direct Marketing DI
- 076401589705460764015897051507640158970539
- EMDN Code
- G99 Gastrointestinal devices - other
- Device Class
- Class III
- Market of Registration
- GreeceItalyPortugal
Manufacturer details
- EUDAMED SRN
- CH-MF-000047475
- Authorised representative
- ALFASIGMA S.P.A. IT-AR-000047395
Other devices from Sofar Swiss SA
Properties & raw data
Show properties, registry sources and raw records
Other properties (12)
- Sterile: No
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No
Sources (3)
- EUDAMED 3a3e6f8a-8ebe-4a7d-893f-8646418ae4d2
- EUDAMED 07640158970515|764015897GERDOFFSE
- EUDAMED 07640158970539|764015897GERDOFFSE