Unisil
by Unisur Lifecare Private Limited 273 variants
Part of a family of 321 devices: see the family page
Ref N5001Model 5F70DY30
Unisil (N5001) is a Class IIb device made by Unisur Lifecare Private Limited, registered in EUDAMED on 4 May 2026 (Basic UDI-DI 890430012015ULSSS0054R), active as of 7 Nov 2026.
Active
CE MDR
Valid until
31 Jan 2030
FDA recalls
Not applicable
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number890430012015ULSSS0054R 08904300142984 | Date4 May 2026 | StatusActive |
Official records
- EUDAMED public site 890430012015ULSSS0054R
Certificates
- 2025-MDR/QS-010/A Active
Quality management system EU MDR
- Certifier
- 3EC International a.s. 2265
- Issued
- 8 Jan 2026
- Expires
- 31 Jan 2030
- Reason
- Other
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device name
- Black Braided Silk Suture
- Model / reference
- 5F70DY30, N5001
- Primary DI / UDI-DI
- 08904300142984
- Basic UDI-DI
- 890430012015ULSSS0054R
- EMDN code
- H010202020301 Silk with needle
- Device class
- Class IIb
- EU registration type
- Standard device
- EU market of registration
- Lithuania
Manufacturer details
- EUDAMED SRN
- IN-MF-000008184
- Authorised representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
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