Identity
- Device Name
- Resuscitation Face Shield EUDAMED
- Model / Reference
- 9568-M9 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05020581291562 EUDAMED
- Basic UDI-DI
- 5020581STE012JR EUDAMED
- EMDN Code
- R030199 RESPIRATORY MASKS - OTHER 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
Category: Anaesthesia face mask, single-use
Resuscitation Face Shield by Steroplast Healthcare Ltd — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Anaesthesia face mask, single-use.
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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 | 5020581STE012JR | 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 7757e877-03ee-4a67-8c39-878be7116cd4 61 fields · synced Jun 18, 2026