Flexigrip
by Praesidia S.r.l. 21 variants
Part of a family of 22 devices: see the family page
Ref FG0400-1
Flexigrip (FG0400-1) is a Class IIb device made by Praesidia S.r.l., registered in EUDAMED on 15 Jun 2026 (Basic UDI-DI 803367578FLEXIGRIPTY) with CE/MDR certificate MDR 00005-A valid until 3 Dec 2030, active as of 25 Oct 2026.
Active
CE MDR
Valid until
3 Dec 2030
FDA recalls
Not applicable
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number803367578FLEXIGRIPTY 08033675780290 | Date15 Jun 2026 | StatusActive |
Official records
- EUDAMED public site 803367578FLEXIGRIPTY
Certificates
- MDR 00005-A Active
Quality management system EU MDR
- Certifier
- KIWA CERMET ITALIA S.P.A. 0476
- Issued
- 4 Dec 2025
- Expires
- 3 Dec 2030
Timeline
- Certificate issued EUDAMED MDR 00005-A
- Registered EUDAMED 803367578FLEXIGRIPTY
- Certificate expires EUDAMED MDR 00005-A
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Model / reference
- FG0400-1
- Primary DI / UDI-DI
- 08033675780290
- Basic UDI-DI
- 803367578FLEXIGRIPTY
- EMDN code
- H02010202 Sternal clips
- Device class
- Class IIb
- EU registration type
- Standard device
- EU market of registration
- Italy
Manufacturer details
- EUDAMED SRN
- IT-MF-000010975
Similar devices in this category
Other devices filed under CLIPS.