Unisynth Pds
by Unisur Lifecare Private Limited EUDAMED
Active
Ref 9D75DZ40Model 9E70DZ25
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number890430012015ULSSS0094Z | Date31 Jan 2026 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/MDR Active
Certificates
- 2025-MDR/QS-007/A Issued
Quality management system EU MDR
- Notified body
- 3EC International a.s. 2265
- Issued
- 8 Jan 2026
- Expires
- 31 Jan 2030
- 2025-MDR/TD-007/A Issued
Technical documentation EU MDR
- Notified body
- 3EC International a.s. 2265
- Issued
- 8 Jan 2026
- Expires
- 31 Jan 2030
Specification
- Device Name
- Monofilament Polydioxanone Suture
- Model / Reference
- 9E70DZ25, 9D75DZ40
- Primary DI / UDI-DI
- 08904300116398
- Basic UDI-DI
- 890430012015ULSSS0094Z
- EMDN Code
- H010101010101 Polydioxanone monofilament with needle for open surgery
- Device Class
- Class III
- Market of Registration
- France
Manufacturer details
- EUDAMED SRN
- IN-MF-000008184
- Authorised representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Other devices from Unisur Lifecare Private Limited
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