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Oxygen Mask Set
EUDAMEDClass IIa (EU MDR)
Ref MSK-16Model MSKRef MSK-10Ref MSK-22Ref MSK12Ref MSK24
Identity
- Trade Name
- Oxygen Mask Set EUDAMED
- Device Name
- Oxygen Mask Set EUDAMED
- Model / Reference
- MSK EUDAMEDMSK-16 EUDAMEDMSK-10 EUDAMEDMSK-22 EUDAMEDMSK12 EUDAMEDMSK24 EUDAMED
Identifiers
- Primary DI / UDI-DI
- MSK-16 EUDAMEDD-MSK-10F6 EUDAMEDMSK-22 EUDAMEDMSK12 EUDAMEDMSK24 EUDAMED
- Basic UDI-DI
- ++G401MSKSW EUDAMEDB-MSK-10F6 EUDAMEDB-MSK12 EUDAMEDB-MSK24 EUDAMED
- Direct Marketing DI
- MSK-16 EUDAMEDMSK-22 EUDAMED
- EMDN Code
- R03010201 AIR/OXYGEN MASKS EUDAMED
Classification
- Device Class
- Class IIa EUDAMEDClass I EUDAMED
- Market of Registration
- Germany EUDAMEDNetherlands EUDAMED
Clinical & Handling
Sterile
Yes
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
Oxygen Mask Set by Disposafe Health & Lifecare Limited — Class IIa — MDD, MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | ++G401MSKSW | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | ++G401MSKSW | Class IIa | Active |
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Manufacturer
- Manufacturer
- Disposafe Health & Lifecare Limited
- EUDAMED SRN
- IN-MF-000020265
- Authorised Representative
- AR Experts B.V. NL-AR-000023989
Sources (5)
- EUDAMED e0521ee6-40e5-40e6-b669-79fe9e57515a 61 fields · synced Jul 31, 2026
- EUDAMED 3673a2b6-35ea-489b-b41c-f7a4c26d6eb8 61 fields · synced May 18, 2026
- EUDAMED 0296dc5a-9364-4999-9c4b-8645ee6bc017 61 fields · synced May 19, 2026
- EUDAMED f873fa35-80d8-4dd5-9113-f3d80fbda357 61 fields · synced Jul 21, 2026
- EUDAMED 8e36c750-f0ac-4edf-9c5b-e66bea943991 61 fields · synced Jul 25, 2026