Assufil Monofilamento P(La-Cl)
by Assut Europe SpA EUDAMED
Active
Ref FX489MGW
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number8033439ASSUFILM-PLACLYC | Date6 Mar 2026 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- 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
- CVD0034240124 Supplemented
Technical documentation EU MDR
- Notified body
- ISTITUTO SUPERIORE DI SANITA' 0373
- Issued
- 14 Oct 2024
- Expires
- 7 Aug 2028
- Reason
- Add device or group
Specification
- Model / Reference
- FX489MGW
- Primary DI / UDI-DI
- 38033439459272
- Basic UDI-DI
- 8033439ASSUFILM-PLACLYC
- Direct Marketing DI
- 38033439459272
- EMDN Code
- H0101010199 Monofilament absorbable synthetic sutures - other
- Device Class
- Class III
- Market of Registration
- Italy
Manufacturer details
- EUDAMED SRN
- IT-MF-000018178
Other devices from Assut Europe SpA
Properties
Show 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