Identity
- Trade Name
- URGOTUL Duo EUDAMED
- Device Name
- URGOTUL Duo EUDAMED
- Model / Reference
- 603585 EUDAMED603586 EUDAMED603591 EUDAMED603594 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03546890044573 EUDAMED03546890044597 EUDAMED03546890044627 EUDAMED03546890044658 EUDAMED
- Basic UDI-DI
- 354689UM00344Z EUDAMED
- EMDN Code
- M040499 DRESSINGS FOR WOUNDS, SORES AND ULCERATIONS - OTHER EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Northern Ireland EUDAMEDGermany EUDAMED
Clinical & Handling
Sterile
Yes
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
Category: Negative-pressure wound therapy system foam dressing, non-antimicrobial
URGOTUL Duo by Laboratoires Urgo — Class IIb — MDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Negative-pressure wound therapy system foam dressing, non-antimicrobial.
- ALIVIOVISCO — LIDERMED S.A. · Class I
- Gamgee BP – Non-sterile 45x45cm — Robinson Healthcare Ltd · Class I
- Herpatch — Sylphar nv · Class IIa
- N1 Psoriasis Intens Crème — PK Benelux BV · Class IIa
- Polyurethane Foam Dressing — Shandong Shinrise Medical Supplies Co., Ltd. · Class IIa
- Holland & Barrett Eczeem crème — PK Benelux BV · Class IIa
- Paraffin gauze dressings — Roosin Medical Co., Ltd. · Class IIa
- Innomed — Zhejiang Longterm Medical Technology Co., Ltd. · Class IIb
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 | 354689UM00344Z | Class IIb | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Laboratoires Urgo
- EUDAMED SRN
- FR-MF-000002559
Sources (4)
- EUDAMED c5f8ced9-aecd-414b-9480-20e47f834720 61 fields · synced Jul 25, 2026
- EUDAMED e0e8d18c-cbd5-476e-9ef7-dc7e9c694cb5 61 fields · synced May 17, 2026
- EUDAMED 0cd09c85-f7f9-4fd7-bfd6-2e3a9570bf59 61 fields · synced May 18, 2026
- EUDAMED 2b3299d9-bede-47ef-9e76-38fff792224b 61 fields · synced May 18, 2026