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Aerogen Solo Nebuliser (10 Pack)
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref AG-AS3200
by Aerogen Ltd
Identity
- Trade Name
- Aerogen Solo Nebuliser (10 Pack) EUDAMEDAerogen® Solo Nebulizer System FDA UDI
- Generic Name
- Therapeutic agent nebulizer, benchtop FDA UDI
- Device Name
- Solo Nebuliser (10 Pack) FDA UDI
- Model / Reference
- AG-AS3200 EUDAMEDFDA UDI
- Description
- Solo Nebuliser (10 Pack) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05391517930245 EUDAMEDFDA UDI
- Basic UDI-DI
- B-05391517930245 EUDAMED
- 510(k) Number
- K070642 FDA UDI
- FDA Product Code
- CAF FDA UDI
- EMDN Code
- R0699 NEBULISATION AND HUMIDIFICATION SYSTEMS - OTHER EUDAMED
- GMDN Term
- Therapeutic agent nebulizer, benchtop FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 868.5630 FDA UDI
- Market of Registration
- Ireland 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
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
MR Unsafe FDA UDI
Aerogen Solo Nebuliser (10 Pack) by Aerogen Ltd — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-05391517930245 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Aerogen Ltd
- EUDAMED SRN
- IE-MF-000004597
Sources (2)
- EUDAMED 0bc774c4-771a-4306-a1a2-10eee5caf53d 61 fields · synced Jul 19, 2026
- FDA UDI 16d8d484-49c8-4d5d-b3cd-e29436d87252 36 fields · synced May 30, 2026