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Silicone Mask
EUDAMEDClass IIa (EU MDR)
Ref S-100-5-ENModel S-100-5Ref S-100-0-ENModel S-100-0Ref S-110-11-ENModel S-110-11Ref S-100-2-ENModel S-100-2Ref S-100-3-ENModel S-100-3
Identity
- Trade Name
- Silicone Mask EUDAMED
- Device Name
- Silicone Mask EUDAMED
- Model / Reference
- S-100-5 EUDAMEDS-100-5-EN EUDAMEDS-100-0 EUDAMEDS-100-0-EN EUDAMEDS-110-11 EUDAMEDS-110-11-EN EUDAMEDS-100-2 EUDAMEDS-100-2-EN EUDAMEDS-100-3 EUDAMEDS-100-3-EN EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04719875340932 EUDAMED04719875340789 EUDAMED04719875340970 EUDAMED04719875340840 EUDAMED04719875340871 EUDAMED
- Basic UDI-DI
- B-04719875340932 EUDAMEDB-04719875340789 EUDAMEDB-04719875340970 EUDAMEDB-04719875340840 EUDAMEDB-04719875340871 EUDAMED
- EMDN Code
- R03010101 ANAESTHETIC FACE MASKS EUDAMEDR0301010401 CPAP HELMETS AND KITS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Austria EUDAMEDTürkiye EUDAMEDGermany 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-04719875340932 | 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 (5)
- EUDAMED c1f067ff-c104-4a82-a354-b79128eb7b3d 61 fields · synced Jul 26, 2026
- EUDAMED 12381fcb-2e5c-4c51-b131-83c2d8b36703 61 fields · synced May 18, 2026
- EUDAMED f4cbf099-6f42-4170-8e77-6efca6d277d7 61 fields · synced May 18, 2026
- EUDAMED a2d5ab3b-4140-4aa4-8d4f-23b8a5dd076d 61 fields · synced May 18, 2026
- EUDAMED b5605f33-94b9-4466-9868-0b05e9154660 61 fields · synced May 19, 2026