Identity
- Device Name
- Non-sterile Adhesive Dressings EUDAMED
- Model / Reference
- 8046FC EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05020581284717 EUDAMED
- Basic UDI-DI
- 5020581STE010JM EUDAMED
- Direct Marketing DI
- 05020581284700 EUDAMED
- EMDN Code
- M0412 DRESSINGS FOR THE TREATMENT OF WARTS, CORNS AND CALLUSES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Malta 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
Non-sterile Adhesive Dressings by Steroplast Healthcare Ltd — Class I — 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 | 5020581STE010JM | Class I | Active |
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Manufacturer
- Manufacturer
- Steroplast Healthcare Ltd
- EUDAMED SRN
- GB-MF-000018088
- Authorised Representative
- Advena Limited MT-AR-000000234
Sources (1)
- EUDAMED da413930-c1fc-40f7-bb98-356c722f77d5 61 fields · synced Jun 18, 2026