Fresa Pilota
by Saeg srl
Ref FIP-120
Active
CE MDR
Valid until
7 May 2028
FDA recalls
Not applicable
Documents
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number805361029FREPILB7 08053610291551 | Date1 Jul 2026 | StatusActive |
Certificates
- 0425-MDR-030024-01 Active
Quality management system EU MDR
- Certifier
- ICIM S.P.A. 0425
- Issued
- 8 May 2023
- Expires
- 7 May 2028
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- FREPIL Fresa Pilota
- Model / Reference
- FIP-120
- Primary DI / UDI-DI
- 08053610291551
- Basic UDI-DI
- 805361029FREPILB7
- EMDN Code
- L149009 ENT surgery burs, reusable
- Device Class
- Class IIa
- EU market of registration
- Italy
Manufacturer details
- EUDAMED SRN
- IT-MF-000022747
Other devices from Saeg SRL
Properties
Other properties (12)
- Sterile: No
- Implantable: 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