Identity
- Trade Name
- URGO KOne EUDAMED
- Device Name
- URGO K1 - URGO KOne EUDAMED
- Model / Reference
- 603623 EUDAMED603622 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03546890044948 EUDAMED03546890044931 EUDAMED
- Basic UDI-DI
- 354689UM01535A EUDAMED
- EMDN Code
- M0304010102 ELASTIC COMPRESSION BANDAGES, NON-ADHESIVE, MEDIUM EXTENSIBILITY (70-140%) EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Northern Ireland EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
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 KOne 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 | 354689UM01535A | Class I | Active |
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Manufacturer
- Manufacturer
- Laboratoires Urgo
- EUDAMED SRN
- FR-MF-000002559
Sources (2)
- EUDAMED e67cae87-f25c-4e3b-8d94-4eca5938b59d 61 fields · synced Jul 27, 2026
- EUDAMED f958b22b-20d5-4eda-a4da-9118cb059db6 61 fields · synced May 18, 2026