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URGOCLEAN Border
EUDAMEDClass IIb (EU MDR)
Ref 604793Ref 605702Ref 604794Ref 604796Ref 605703Ref 604795Ref 604155Ref 604154
Identity
- Trade Name
- URGOCLEAN Border EUDAMED
- Device Name
- URGOCLEAN Border EUDAMED
- Model / Reference
- 604793 EUDAMED605702 EUDAMED604794 EUDAMED604796 EUDAMED605703 EUDAMED604795 EUDAMED604155 EUDAMED604154 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03546890049448 EUDAMED03546890050567 EUDAMED03546890049455 EUDAMED03546890049479 EUDAMED03546890050581 EUDAMED03546890049462 EUDAMED03546890047079 EUDAMED03546890047062 EUDAMED
- Basic UDI-DI
- 354689UM01865R EUDAMED
- EMDN Code
- M040499 DRESSINGS FOR WOUNDS, SORES AND ULCERATIONS - OTHER EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Germany 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
URGOCLEAN Border 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.
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- Herpatch — Sylphar nv · Class IIa
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- 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 | 354689UM01865R | Class IIb | Active |
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Manufacturer
- Manufacturer
- Laboratoires Urgo
- EUDAMED SRN
- FR-MF-000002559
Sources (8)
- EUDAMED f5121ee2-ffb7-479e-aaea-90c79d1c368b 61 fields · synced Jul 31, 2026
- EUDAMED 5bfe28a0-b67a-4c64-89e2-fa3701e73bcf 61 fields · synced May 16, 2026
- EUDAMED bff327bb-3434-4dfd-8c4e-c1e837cfdeac 61 fields · synced May 16, 2026
- EUDAMED c783d892-97e6-4573-b29e-55ad1255f9e2 61 fields · synced May 17, 2026
- EUDAMED 3125a56c-4eb9-48df-966f-147a8c4862a8 61 fields · synced May 17, 2026
- EUDAMED abd49fd3-ef73-48b5-b49b-977c9420fb50 61 fields · synced May 18, 2026
- EUDAMED 85883803-dec9-4079-9042-c43544e53b4f 61 fields · synced May 18, 2026
- EUDAMED cbb0af5b-33d0-47e1-a0fe-7d3300a82b97 61 fields · synced May 18, 2026