Identity
- Device Name
- Face Mask EUDAMED
- Model / Reference
- 1816/5 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05020581290381 EUDAMED
- Basic UDI-DI
- 5020581STE004JS EUDAMED
- Unit of Use DI
- 05020581288036 EUDAMED
- EMDN Code
- T020604 MEDICAL USE FACE MASKS, TYPE II AND IIR 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
Face Mask 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 | 5020581STE004JS | 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 c2362668-414b-4514-8abe-5380bf7b685a 61 fields · synced Jul 11, 2026