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Isolated Nebulizer Kit
EUDAMEDClass IIa (EU MDR)
Ref AD0035Model (E) Aerosol Therapy
Identity
- Trade Name
- Isolated Nebulizer Kit EUDAMED
- Device Name
- Isolated Nebulizer Kit EUDAMED
- Model / Reference
- (E) Aerosol Therapy EUDAMEDAD0035 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04710810081835 EUDAMED
- Basic UDI-DI
- 471081008NNE57F 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
Isolated Nebulizer Kit 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 | 471081008NNE57F | 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 60cd3973-adb5-4682-9f6a-ff52f298df7f 61 fields · synced Jun 18, 2026