Identity
- Trade Name
- UNISIL EUDAMED
- Device Name
- Black Braided Silk Suture EUDAMED
- Model / Reference
- 5F70DY30 EUDAMED5I45CZ11DA EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08904300124843 EUDAMED
- Basic UDI-DI
- 890430012015ULSSS0054R EUDAMED
- EMDN Code
- H010202020301 SILK WITH NEEDLE EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Lithuania EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
Yes
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Sutures
Yes
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Unisil by Unisur Lifecare Private Limited — Class IIb — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 890430012015ULSSS0054R | Class IIb | Active |
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Manufacturer
- Manufacturer
- Unisur Lifecare Private Limited
- EUDAMED SRN
- IN-MF-000008184
- Authorised Representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Sources (1)
- EUDAMED eb5844dd-30c2-4860-9850-a71559562b7f 61 fields · synced Jun 20, 2026