Monofil
by Assut Europe SpA Italy EUDAMED
Ref FQ459F
EMDN H010101010301
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number8033439MONOFIL3T | Date8 Jun 2026 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/MDR Active
Certificates
- CSQ0013236626 Supplemented
Quality management system EU MDR
- Notified body
- ISTITUTO SUPERIORE DI SANITA' 0373
- Issued
- 28 Sep 2026
- Expires
- 7 Aug 2028
- Reason
- Add device or group
- CVD0049250426 Supplemented
Technical documentation EU MDR
- Notified body
- ISTITUTO SUPERIORE DI SANITA' 0373
- Issued
- 28 Sep 2026
- Expires
- 7 Aug 2028
- Reason
- Add device or group
Specification
- Model / Reference
- FQ459F
- Primary DI / UDI-DI
- 18033439455140
- Basic UDI-DI
- 8033439MONOFIL3T
- Direct Marketing DI
- 18033439455140
- EMDN Code
- H010101010301 Poliglecaprone and derivatives monofilament with needle
- Device Class
- Class III
- Market of Registration
- Italy
Manufacturer details
- EUDAMED SRN
- IT-MF-000018178
Other devices from Assut Europe SpA
Properties & raw data
Show properties, registry sources and raw records
Other properties (11)
- Reusable: 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
Sources (1)
- EUDAMED 18033439455140|8033439MONOFIL3T