MaioRegen Slim
by Fin-ceramica faenza spa 5 variants
Ref 01600290Model MaioRegen
Active
CE MDR CE MDD
Valid until
12 Mar 2028
FDA recalls
Not applicable
Documents
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | NumberCSQ0008230326 | Date31 Mar 2026 | StatusActive |
| European Union | CE/MDD | Number805418816MaioRegenCF | Date28 Mar 2023 | StatusActive |
Certificates
- CSQ0008230326 Active
Quality management system EU MDR
- Notified body
- ISTITUTO SUPERIORE DI SANITA' 0373
- Issued
- 31 Mar 2026
- Expires
- 12 Mar 2028
- CVD000423 Active
Technical documentation EU MDR
- Notified body
- ISTITUTO SUPERIORE DI SANITA' 0373
- Issued
- 13 Mar 2023
- Expires
- 12 Mar 2028
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDD, CE/MDR Active
Specification
- Model / Reference
- MaioRegen, 01600290
- Primary DI / UDI-DI
- 18054188161045
- Basic UDI-DI
- 805418816MaioRegenCF, B-18054188161045
- EMDN Code
- P900402 Resorbable filling and reconstruction devices
- Device Class
- Class III
- Market of Registration
- Italy
Manufacturer details
- EUDAMED SRN
- IT-MF-000023496
Other devices from Fin-ceramica faenza spa
Properties
Other properties (10)
- 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