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Neb.Easy AM-2 Mask, Adult w/Tube
EUDAMEDClass IIa (EU MDR)
Ref AD0061Model (E) Aerosol TherapyRef AD0054
Identity
- Trade Name
- Neb.Easy AM-2 Mask, Adult w/Tube EUDAMED
- Device Name
- Nebulizer Kit, w/mask EUDAMED
- Model / Reference
- (E) Aerosol Therapy EUDAMEDAD0061 EUDAMEDAD0054 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04710810089480 EUDAMED04710810085949 EUDAMED
- Basic UDI-DI
- 471081008NNE177 EUDAMED
- EMDN Code
- R03010301 AEROSOL THERAPY MASKS 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.Easy AM-2 Mask, Adult w/Tube 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 (2)
- EUDAMED d9ed868d-3122-4ef5-8cde-e5363c966b4a 61 fields · synced Oct 6, 2026
- EUDAMED aa49091c-3850-4b12-8f9c-18ae37e8e227 61 fields · synced May 19, 2026