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Air Cushion Masks
EUDAMEDClass IIa (EU MDR)
Ref 6001-EN1Model 6001Ref 6002-EN1Model 6002Ref 6003-EN1Model 6003
Identity
- Trade Name
- Air Cushion Masks EUDAMED
- Device Name
- Air Cushion Masks EUDAMED
- Model / Reference
- 6001 EUDAMED6001-EN1 EUDAMED6002 EUDAMED6002-EN1 EUDAMED6003 EUDAMED6003-EN1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04719875341113 EUDAMED04719875341144 EUDAMED04719875341175 EUDAMED
- Basic UDI-DI
- B-04719875341113 EUDAMEDB-04719875341144 EUDAMEDB-04719875341175 EUDAMED
- EMDN Code
- R03010101 ANAESTHETIC FACE MASKS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Slovakia 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
Category: Anaesthesia face mask, single-use
Air Cushion Masks by VADI Medical Technology Co., Ltd. — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Anaesthesia face mask, single-use.
- Ventlab — Ventlab Corp. · Class I
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- Anesthesia Mask — XIAMEN COMPOWER MEDICAL TECH. CO., LTD. · Class IIa
- Vital Signs™ — Airlife, Inc. · Class I
- Ventlab — Ventlab Corp. · Class I
- Anesthesia mask — Henan Tuoren Medical Device Co., Ltd · Class IIa
- Anesthesia Mask — XIAMEN COMPOWER MEDICAL TECH. CO., LTD. · Class IIa
- King Mask — Ambu A/S · Class I
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-04719875341113 | 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 (3)
- EUDAMED 0d0dddeb-0ed1-474c-8155-8ba52d05bdba 61 fields · synced Sep 18, 2026
- EUDAMED c9b3227c-1230-4475-b414-4a43dca6a86c 61 fields · synced May 17, 2026
- EUDAMED d1c962b4-b5b0-4781-a942-9c0c2e641c5a 61 fields · synced May 18, 2026