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Neb.Super Mask Kit, Adult
EUDAMEDClass IIa (EU MDR)
Ref AD0020Model (E) Aerosol Therapy
Identity
- Trade Name
- Neb.Super Mask Kit, Adult EUDAMED
- Device Name
- Nebulizer Kit, w/mask EUDAMED
- Model / Reference
- (E) Aerosol Therapy EUDAMEDAD0020 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04710810119989 EUDAMED
- Basic UDI-DI
- 471081008NNE177 EUDAMED
- EMDN Code
- R03010304 AEROSOL THERAPY KITS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Netherlands 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
Neb.Super Mask Kit, Adult by GaleMed Corporation — Class IIa — 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 | 471081008NNE177 | Class IIa | Active |
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Manufacturer
- Manufacturer
- GaleMed Corporation
- EUDAMED SRN
- TW-MF-000022411
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (1)
- EUDAMED 675391fc-7d0f-46b9-bfa8-799e421df028 61 fields · synced Jul 19, 2026