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RF1 Nebulizer w/Valve T Kit, 22M, 22M
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref AD0006Model (E) Aerosol Therapy
Identity
- Trade Name
- RF1 Nebulizer w/Valve T Kit, 22M, 22M EUDAMEDNeb.Plus FDA UDI
- Generic Name
- Nasopharyngeal airway, reusable FDA UDI
- Device Name
- Nebulizer Kit EUDAMED
- Model / Reference
- (E) Aerosol Therapy EUDAMEDAD0006 EUDAMEDNV33 FDA UDI
Identifiers
- Catalog Number
- RF1 Nebulizer w/Neb-1.T Valve Kit, 22M, 22M FDA UDI
- Primary DI / UDI-DI
- 04710810100550 EUDAMEDFDA UDI
- Basic UDI-DI
- 471081008NNED8B EUDAMED
- FDA Product Code
- BZA FDA UDI
- EMDN Code
- R03010304 AEROSOL THERAPY KITS EUDAMED
- GMDN Term
- Nasopharyngeal airway, reusable FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 868.5810 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
RF1 Nebulizer w/Valve T Kit, 22M, 22M by GaleMed Corporation — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 471081008NNED8B | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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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 8d8df0cb-f9e4-4f24-b231-1b42fb5d0429 61 fields · synced Jul 20, 2026
- FDA UDI 8469b305-d2f4-4d7b-be51-c25fa2c68c19 33 fields · synced May 30, 2026