Identity
- Trade Name
- UNIMIDE B EUDAMED
- Device Name
- Sterile Single Use Synthetic Non-Absorbable Surgical Suture with or without needle EUDAMED
- Model / Reference
- UNIMIDE B EUDAMEDDW5328R EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06285379058591 EUDAMED
- Basic UDI-DI
- B-06285379058591 EUDAMED
- EMDN Code
- H010201020101,H010201020102 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
Unimide B 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-06285379058591 | 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 5cb08492-7cdd-415a-8535-f237b172e34e 61 fields · synced Jul 14, 2026