AssuCryl®
by Assut Medical Sàrl 516 variants
Ref 4385WModel Sterile synthetic absorbable surgical suture material
Active
CE MDR
Valid until
1 Jan 2030
FDA recalls
Not applicable
Documents
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number07613406ACLPGA8T | Date23 Sep 2026 | StatusActive |
Certificates
- 2262886CE01 Active
Quality management system EU MDR
- Certifier
- DEKRA Certification B.V. 0344
- Issued
- 1 Aug 2025
- Expires
- 1 Jan 2030
- Reason
- Ar data change
- 2262886TD01 Active
Technical documentation EU MDR
- Certifier
- DEKRA Certification B.V. 0344
- Issued
- 1 Sep 2025
- Expires
- 1 Jan 2030
- Reason
- Change approved
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
- Ireland
Specification
- Device Name
- AssuCryl (PGA)
- Model / Reference
- Sterile synthetic absorbable surgical suture material, 4385W
- Primary DI / UDI-DI
- 07613406146062, 07613406146079
- Basic UDI-DI
- 07613406ACLPGA8T
- EMDN Code
- H010101020101 Polyglycolic acid multifilament with needle for open surgery
- Device Class
- Class III
- EU market of registration
- Ireland
Manufacturer details
- EUDAMED SRN
- CH-MF-000009358
- Authorised representative
- Medical Technology Promedt Consulting GmbH DE-AR-000000085
Other devices from Assut Medical Sàrl
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