Identity
- Trade Name
- UNIESTER EUDAMED
- Device Name
- Sterile Single Use Synthetic Non-Absorbable Surgical Suture with or without needle EUDAMED
- Model / Reference
- UNIESTER EUDAMEDDW6140DS EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06285379032386 EUDAMED
- Basic UDI-DI
- B-06285379032386 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 by United Medical Industries Co. Ltd — Class III — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-06285379032386 | 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 (1)
- EUDAMED 7c46c356-ad6b-4be9-86c2-60ea50c82068 61 fields · synced May 22, 2026