Identity
- Trade Name
- Silicone Mask EUDAMED
- Device Name
- Silicone Mask EUDAMED
- Model / Reference
- S-110-00 EUDAMEDS-110-00-EN EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04719875340963 EUDAMED
- Basic UDI-DI
- B-04719875340963 EUDAMED
- EMDN Code
- R0301010401 CPAP HELMETS AND KITS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany 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
No
EUDAMED
Silicone Mask by VADI Medical Technology Co., Ltd. — Class IIa — 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-04719875340963 | Class IIa | Active |
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Manufacturer
- Manufacturer
- VADI Medical Technology Co., Ltd.
- EUDAMED SRN
- TW-MF-000022930
- Authorised Representative
- MedNet EC-REP IIb GmbH DE-AR-000011192
Sources (1)
- EUDAMED b5941934-b2b5-47b4-a524-3487107e38e7 61 fields · synced Jun 19, 2026