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Aerogen Solo Adult T-Piece 22mm
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref AG-AS3010
by Aerogen Ltd
Identity
- Trade Name
- Aerogen Solo Adult T-Piece 22mm EUDAMEDAerogen® Solo Nebulizer System FDA UDI
- Generic Name
- Therapeutic agent nebulizer, benchtop FDA UDI
- Device Name
- Solo Adult T-Piece 22mm FDA UDI
- Model / Reference
- AG-AS3010 EUDAMEDFDA UDI
- Description
- Solo Adult T-Piece 22mm FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05391517930252 EUDAMEDFDA UDI
- Basic UDI-DI
- B-05391517930252 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 Adult T-Piece 22mm 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-05391517930252 | 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 a8782f00-8f89-4341-bacf-cc9698f7fb6a 61 fields · synced Jun 19, 2026
- FDA UDI 37abed06-e727-469d-8055-ee96953206f2 36 fields · synced May 30, 2026