Identity
- Trade Name
- URGOTUL Border EUDAMED
- Device Name
- URGOTUL Absorb Border - URGOTUL Foam Border - URGOTUL Border EUDAMED
- Model / Reference
- 603557 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03546890044351 EUDAMED
- Basic UDI-DI
- 354689UM01014P EUDAMED
- EMDN Code
- M04040602 POLYURETHANE DRESSINGS, COMBINED WITH OTHER SUBSTANCES EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- France 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
URGOTUL Border by Laboratoires Urgo — Class IIb — 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 | 354689UM01014P | 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 (1)
- EUDAMED 711da56f-be60-4e2b-af6d-e1378a8e1fa8 61 fields · synced May 22, 2026