Identity
- Trade Name
- DR. MAX Silicone EUDAMED
- Device Name
- Plaster with antiseptic gauze EUDAMED
- Model / Reference
- CAT422103 EUDAMEDCAT422110 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08595566422103 EUDAMED08595566422110 EUDAMED
- Basic UDI-DI
- B-08595566422103 EUDAMEDB-08595566422110 EUDAMED
- EMDN Code
- M040412 ANTISEPTICS-BASED DRESSINGS EUDAMED
Classification
- Device Class
- Class III EUDAMED
- Market of Registration
- Czechia EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
Yes
EUDAMED
DR. MAX Silicone by Eurosirel Spa — Class III — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-08595566422103 | Class III | Active |
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Manufacturer
- Manufacturer
- Eurosirel Spa
- EUDAMED SRN
- IT-MF-000005982
Sources (2)
- EUDAMED 14a929ee-a944-486f-827c-6f93740752fd 61 fields · synced Jul 29, 2026
- EUDAMED f628a13e-7995-4aab-acf6-158f9cfbb7cd 61 fields · synced May 19, 2026