Monofix Pgcl
by Samyang Biopharm Corporation 62 variants
Ref KF314ES
Active
CE MDR
Valid until
12 Dec 2029
FDA recalls
Not applicable
Documents
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number2024-MDR/QS-068/B | Date18 Feb 2026 | StatusActive |
Certificates
- 2024-MDR/QS-068/B Active
Quality management system EU MDR
- Certifier
- 3EC International a.s. 2265
- Issued
- 18 Feb 2026
- Expires
- 12 Dec 2029
- Reason
- Add device or group
- 2024-MDR/TD-068/B Active
Technical documentation EU MDR
- Certifier
- 3EC International a.s. 2265
- Issued
- 18 Feb 2026
- Expires
- 12 Dec 2029
- Reason
- Add device or group
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Absorbable Knotless Wound Closure Device
- Model / Reference
- KF314ES
- Primary DI / UDI-DI
- 08809366477868
- Basic UDI-DI
- 880936647KF01LQ
- EMDN Code
- H010101010303 Poliglecaprone and derivatives monofilament with needle for tissue traction (‘barbed’)
- Device Class
- Class III
- EU market of registration
- Netherlands
Manufacturer details
- EUDAMED SRN
- KR-MF-000037085
- Authorised representative
- Samyang Biopharm Magyarország Kft. HU-AR-000035346
Other devices from Samyang Biopharm Corporation
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