Monofil
by Assut Europe SpA 416 variants
Part of a family of 416 devices: see the family page
Ref FRFBG
Monofil (FRFBG) is a Class III device made by Assut Europe SpA, registered in EUDAMED on 8 Jun 2026 (Basic UDI-DI 8033439MONOFIL3T) with CE/MDR certificate CSQ0013236826 valid until 7 Aug 2028, active as of 24 Oct 2026.
Active
CE MDR
Valid until
7 Aug 2028
FDA recalls
Not applicable
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | NumberCSQ0013236826 | Date26 Oct 2026 | StatusActive |
Official records
- EUDAMED public site 8033439MONOFIL3T
Certificates
- CSQ0013236626 Active
Quality management system EU MDR
- Certifier
- ISTITUTO SUPERIORE DI SANITA' 0373
- Issued
- 28 Sep 2026
- Expires
- 7 Aug 2028
- Reason
- Add device or group
- CSQ0013236826 Active
Quality management system EU MDR
- Certifier
- ISTITUTO SUPERIORE DI SANITA' 0373
- Issued
- 26 Oct 2026
- Expires
- 7 Aug 2028
- Reason
- Add device or group
- CVD0049250426 Active
Technical documentation EU MDR
- Certifier
- ISTITUTO SUPERIORE DI SANITA' 0373
- Issued
- 28 Sep 2026
- Expires
- 7 Aug 2028
- Reason
- Add device or group
Timeline
- Registered EUDAMED 8033439MONOFIL3T
- Certificate issued EUDAMED CVD0049250426
- Certificate issued EUDAMED CSQ0013236826
- Certificate expires EUDAMED CSQ0013236826
- Certificate expires EUDAMED CVD0049250426
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Model / reference
- FRFBG
- Primary DI / UDI-DI
- 18033439456659
- Basic UDI-DI
- 8033439MONOFIL3T
- Direct marketing DI
- 18033439456659
- EMDN code
- H010101010302 Poliglecaprone and derivatives monofilament without needle
- Device class
- Class III
- EU registration type
- Standard device
- EU market of registration
- Italy
Manufacturer details
- EUDAMED SRN
- IT-MF-000018178
Similar devices in this category
Other devices filed under POLIGLECAPRONE AND DERIVATIVES MONOFILAMENT WITHOUT NEEDLE.