Identity
- Trade Name
- URGO EUDAMED
- Device Name
- Acne Solve EUDAMED
- Model / Reference
- AG74000012 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08053300890927 EUDAMED
- Basic UDI-DI
- 805330089TD04ACNEBR EUDAMED
- EMDN Code
- M0499 SPECIAL DRESSINGS - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- France 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
Category: Scar-management dressing, reusable
Urgo by ALMA s.r.l. — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Scar-management dressing, reusable.
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- Cimeosil® Scar Management, Gel Sheet — Implantech Associates, Inc. · Class I
- THERAFOAM — BIODERMIS LLC · Class I
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 | 805330089TD04ACNEBR | Class IIa | Active |
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Manufacturer
- Manufacturer
- ALMA s.r.l.
- EUDAMED SRN
- IT-MF-000029690
Sources (1)
- EUDAMED 98074c9d-22cb-44a2-b37f-04857cbf8367 61 fields · synced Jul 21, 2026