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Neb.Super Nebulizer Kit
EUDAMEDClass IIa (EU MDR)
Ref AD0018Model (E) Aerosol Therapy
Identity
- Trade Name
- Neb.Super Nebulizer Kit EUDAMED
- Device Name
- Nebulizer Kit EUDAMED
- Model / Reference
- (E) Aerosol Therapy EUDAMEDAD0018 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04710810119965 EUDAMED
- Basic UDI-DI
- 471081008NNED8B 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 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 | 471081008NNED8B | 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 2206245f-3989-45de-ac9c-83a20e6f733a 61 fields · synced Jul 15, 2026