Identity
- Trade Name
- UNIGLACTIN EUDAMED
- Device Name
- Sterile Single Use Synthetic Absorbable Surgical Suture with or without needle EUDAMED
- Model / Reference
- UNIGLACTIN EUDAMEDSD11157U EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06285379106476 EUDAMED
- Basic UDI-DI
- B-06285379106476 EUDAMED
- EMDN Code
- H010101020201,H010101020203 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
Uniglactin 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 | K072645 | Class III | Active |
| EUDAMED | European Union | CE/MDD | B-06285379106476 | 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 f396d6f8-d43e-45e6-a0ba-45b8b5ec9a75 61 fields · synced Jul 24, 2026
- FDA 510(k) K072645 1 fields · synced May 18, 2026