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Aerogen Solo T-Piece 10 mm
EUDAMEDClass IIb (EU MDR)
Ref AG-AS3036Model AG-AS3010
by Aerogen Ltd
Identity
- Trade Name
- Aerogen Solo T-Piece 10 mm EUDAMEDAerogen Solo Ped T-Piece 10mm EUDAMED
- Device Name
- Aerogen Solo Adult T-Piece EUDAMEDAerogen Solo T-Piece EUDAMED
- Model / Reference
- AG-AS3010 EUDAMEDAG-AS3036 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05391517937787 EUDAMED
- Basic UDI-DI
- 539151793AG00010WB EUDAMED
- EMDN Code
- R060101 COLD NEBULISATION SYSTEMS EUDAMED
Classification
- Device Class
- Class IIb EUDAMEDClass IIa EUDAMED
- Market of Registration
- Austria 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
Aerogen Solo T-Piece 10 mm by Aerogen Ltd — Class IIb — 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 | 539151793AG00010WB | Class IIb | Active |
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Manufacturer
- Manufacturer
- Aerogen Ltd
- EUDAMED SRN
- IE-MF-000004597
Sources (2)
- EUDAMED 86c3aa73-ef8a-449a-83ef-ce14db2f8c59 61 fields · synced Jul 24, 2026
- EUDAMED 1c2e722b-721e-4cf5-ac03-220c9cd335eb 61 fields · synced Jul 24, 2026