Identity
- Trade Name
- URGO KTwo EUDAMEDURGO KTwo with URGOSTART Contact EUDAMED
- Device Name
- URGO K2 - URGO KTwo EUDAMEDURGO KTwo with URGOSTART Contact EUDAMED
- Model / Reference
- 552907 EUDAMED603008 EUDAMED552895 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03546890029587 EUDAMED03546890042517 EUDAMED03546890029709 EUDAMED
- Basic UDI-DI
- 354689UM00314T EUDAMED354689UM015054 EUDAMED
- EMDN Code
- M03040199 ELASTIC COMPRESSION BANDAGES - OTHER EUDAMEDM9099 GENERAL AND SPECIALIST MEDICAL DEVICES – OTHER (SUTURE PATCHES SEE H900102) EUDAMED
Classification
- Device Class
- Class I EUDAMEDClass IIb EUDAMED
- Market of Registration
- Northern Ireland EUDAMED
- Medical Purpose
- Treatment of venous leg ulcer EUDAMED
Clinical & Handling
Sterile
No
EUDAMEDEUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
Yes
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
URGO KTwo by Laboratoires Urgo — Class I — 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 | 354689UM00314T | Class I | Active |
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Manufacturer
- Manufacturer
- Laboratoires Urgo
- EUDAMED SRN
- FR-MF-000002559
Sources (3)
- EUDAMED a52dc0ac-0cc4-417b-b8f9-c8e035431982 61 fields · synced Sep 17, 2026
- EUDAMED 04734189-ce42-407d-8994-a04f13ef399b 61 fields · synced May 17, 2026
- EUDAMED 3915d0c5-af94-40cf-a2b2-ad2ee0bc1917 61 fields · synced May 18, 2026