Identity
- Trade Name
- UNIESTER C EUDAMED
- Device Name
- Sterile Single Use Synthetic Non-Absorbable Surgical Suture with or without needle EUDAMED
- Model / Reference
- UNIESTER C EUDAMEDDW7413DM6 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06285379034434 EUDAMED
- Basic UDI-DI
- B-06285379034434 EUDAMED
- EMDN Code
- H010201020201,H010201020203 EUDAMED
Classification
- Device Class
- Class III EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
Yes
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Uniester C by United Medical Industries Co. Ltd — Class III — FDA_510K, MDD — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K042286 | Class III | Active |
| EUDAMED | European Union | CE/MDD | B-06285379034434 | Class III | Active |
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Manufacturer
- Manufacturer
- United Medical Industries Co. Ltd
- EUDAMED SRN
- SA-MF-000004541
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED 02131f34-a910-4afa-8bc4-2277a3133880 61 fields · synced Jul 14, 2026
- FDA 510(k) K042286 1 fields · synced May 18, 2026