Unilene
by Unisur Lifecare Private Limited India EUDAMED
Ref 8I75CX16Model 8C70DZ36H
EMDN H010201010401
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number2025-MDR/QS-008/A | Date8 Jan 2026 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/MDR Active
Certificates
- 2025-MDR/QS-008/A Issued
Quality management system EU MDR
- Notified body
- 3EC International a.s. 2265
- Issued
- 8 Jan 2026
- Expires
- 31 Jan 2030
Specification
- Device Name
- Monofilament Polypropylene Suture
- Model / Reference
- 8C70DZ36H, 8I75CX16
- Primary DI / UDI-DI
- 08904300105316
- Basic UDI-DI
- 890430012015ULSSS0084X
- EMDN Code
- H010201010401 Polypropylene monofilament with needle for open surgery
- Device Class
- Class IIb
- Market of Registration
- Lithuania
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 & 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 2df3b2da-2a38-404f-9433-211135906e6c