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Aerogen Solo T-Piece 12mm
EUDAMEDClass IIb (EU MDR)
Ref AG-AS3035Model AG-AS3010
by Aerogen Ltd
Identity
- Trade Name
- Aerogen Solo T-Piece 12mm EUDAMEDAerogen Solo Ped T-Piece 12mm EUDAMED
- Device Name
- Aerogen Solo Adult T-Piece EUDAMEDAerogen Solo T-Piece EUDAMED
- Model / Reference
- AG-AS3010 EUDAMEDAG-AS3035 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05391517937770 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 12mm 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 b0e5614c-4d37-40ab-b2c7-5dc98cf04671 61 fields · synced Jun 19, 2026
- EUDAMED 54c0c7d5-e799-40ee-8f30-abb46c8f6454 61 fields · synced Jun 19, 2026