Identity
- Trade Name
- UNISYNTH EUDAMED
- Device Name
- Braided & Coated Polyglactin 910 Suture EUDAMED
- Model / Reference
- 10E90DZ30 EUDAMED10D75DZ32 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08904300117968 EUDAMED
- Basic UDI-DI
- 890430012015ULSSS0104J EUDAMED
- EMDN Code
- H010101020201 POLYGLYCOLIC WITH LACTIC ACID MULTIFILAMENT WITH NEEDLE FOR OPEN SURGERY EUDAMED
Classification
- Device Class
- Class III EUDAMED
- Market of Registration
- Lithuania EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
Yes
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
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
Unisynth by Unisur Lifecare Private Limited — Class III — 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 | 890430012015ULSSS0104J | Class III | 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 dc923f35-d773-475f-bc07-93a69de37988 61 fields · synced Jun 20, 2026