Assufil Monofilamento
by Assut Europe SpA 510 variants
Ref FX517M
Active
CE MDR
Valid until
7 Aug 2028
FDA recalls
Not applicable
Documents
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | NumberCSQ0013236626 | Date28 Sep 2026 | StatusActive |
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
- CVD0031240425 Active
Technical documentation EU MDR
- Certifier
- ISTITUTO SUPERIORE DI SANITA' 0373
- Issued
- 11 Sep 2025
- Expires
- 7 Aug 2028
- Reason
- Add device or group
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Model / Reference
- FX517M
- Primary DI / UDI-DI
- 38033439401288
- Basic UDI-DI
- 8033439ASSUFILM-PDOUG
- Direct Marketing DI
- 38033439401288
- EMDN Code
- H010101010101 Polydioxanone monofilament with needle for open surgery
- Device Class
- Class III
- EU market of registration
- Italy
Manufacturer details
- EUDAMED SRN
- IT-MF-000018178
Other devices from Assut Europe SpA
Properties
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