Identity
- Device Name
- Face Shield EUDAMED
- Model / Reference
- HNFS20151 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973454361505 EUDAMED
- Basic UDI-DI
- 697345436HNFS20151FD EUDAMED
- EMDN Code
- T0399 PROTECTION DEVICES (EXCLUDING PERSONAL PROTECTIVE EQUIPMENT PPE) - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Austria 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 Shield by Shanghai Hua En Industrial Co 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 | 697345436HNFS20151FD | Class I | Active |
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Manufacturer
- Manufacturer
- Shanghai Hua En Industrial Co Ltd
- EUDAMED SRN
- CN-MF-000008902
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED 2639a2ca-a973-46c5-b755-1148e3aa018b 61 fields · synced Jul 29, 2026