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Urgofit
EUDAMEDClass IIb (EU MDR)
Ref 604137Ref 604142Ref 604143Ref 604308Ref 605031Ref 603862
Identity
- Trade Name
- URGOFIT EUDAMED
- Device Name
- URGOFIT - URGOTÜL Flex EUDAMED
- Model / Reference
- 604137 EUDAMED604142 EUDAMED604143 EUDAMED604308 EUDAMED605031 EUDAMED603862 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03546890046904 EUDAMED03546890046928 EUDAMED03546890046935 EUDAMED03546890047994 EUDAMED03546890049820 EUDAMED03546890046188 EUDAMED
- Basic UDI-DI
- 354689UM01495K EUDAMED
- EMDN Code
- M040499 DRESSINGS FOR WOUNDS, SORES AND ULCERATIONS - OTHER EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- France EUDAMEDSpain 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
Urgofit by Laboratoires Urgo — Class IIb — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Negative-pressure wound therapy system foam dressing, non-antimicrobial.
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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 | 354689UM01495K | Class IIb | Active |
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Manufacturer
- Manufacturer
- Laboratoires Urgo
- EUDAMED SRN
- FR-MF-000002559
Sources (6)
- EUDAMED eb4eaccd-d65b-4d89-8aed-2464ef549298 61 fields · synced Sep 18, 2026
- EUDAMED 0afb1910-b81b-45f8-9282-f6a411acd5f6 61 fields · synced May 11, 2026
- EUDAMED e5629e3e-6dd8-4398-9c7c-b13f43df690a 61 fields · synced May 17, 2026
- EUDAMED 6ae73c68-df49-4438-a110-f5343794a213 61 fields · synced May 17, 2026
- EUDAMED be5b3aa8-0766-479a-ad67-010afc5b7485 61 fields · synced May 18, 2026
- EUDAMED 94f1eb1a-e5ac-4f8f-800f-cab8f1d984ec 61 fields · synced May 18, 2026