Identity
- Trade Name
- UNISYNTH FAST EUDAMED
- Device Name
- Fast Absorbable Braided & Coated Polyglactin 910 Suture EUDAMED
- Model / Reference
- 12F75DZ20U EUDAMED12E45DZ30 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08904300128889 EUDAMED
- Basic UDI-DI
- 890430012015ULSSS0124N EUDAMED
- EMDN Code
- H010101020201 POLYGLYCOLIC WITH LACTIC ACID MULTIFILAMENT WITH NEEDLE FOR OPEN SURGERY EUDAMED
Classification
- Device Class
- Class III EUDAMED
- Market of Registration
- France 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 Fast 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 | 890430012015ULSSS0124N | 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 47614923-5864-4982-9dd3-42eea81d123a 61 fields · synced Jul 15, 2026