AssuCryl® MonoSlow
by Assut Medical Sàrl Switzerland EUDAMED
Ref MS4554FModel Sterile synthetic absorbable surgical suture material
EMDN H010101010101
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number07613406ACLMSPDOLC | Date23 Sep 2026 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/MDR Active
Certificates
- 2262886CE01 Amended
Quality management system EU MDR
- Notified body
- Notified body 0344
- Issued
- 1 Aug 2025
- Expires
- 1 Jan 2030
- Reason
- Ar data change
- 2262886TD01 Supplemented
Technical documentation EU MDR
- Notified body
- Notified body 0344
- Issued
- 1 Sep 2025
- Expires
- 1 Jan 2030
- Reason
- Change approved
Specification
- Device Name
- AssuCryl MonoSlow (PDO)
- Model / Reference
- Sterile synthetic absorbable surgical suture material, MS4554F
- Primary DI / UDI-DI
- 07613406097401
- Basic UDI-DI
- 07613406ACLMSPDOLC
- EMDN Code
- H010101010101 Polydioxanone monofilament with needle for open surgery
- Device Class
- Class III
- Market of Registration
- Romania
Manufacturer details
- EUDAMED SRN
- CH-MF-000009358
- Authorised representative
- Medical Technology Promedt Consulting GmbH DE-AR-000000085
Other devices from Assut Medical Sàrl
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 07613406097401|07613406ACLMSPDOLC