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Aerogen USB Controller
EUDAMEDClass IIb (EU MDR)
Ref AG-UC1000-UKModel AG-UC1000-CE
by Aerogen Ltd
Identity
- Trade Name
- Aerogen USB Controller EUDAMED
- Device Name
- Aerogen USB Controller EUDAMED
- Model / Reference
- AG-UC1000-CE EUDAMEDAG-UC1000-UK EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05391517937978 EUDAMED
- Basic UDI-DI
- 539151793AG00003WE EUDAMED
- Direct Marketing DI
- 05391517936872 EUDAMED
- EMDN Code
- R060101 COLD NEBULISATION SYSTEMS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Ireland 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 USB Controller 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 | 539151793AG00003WE | Class IIb | Active |
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Manufacturer
- Manufacturer
- Aerogen Ltd
- EUDAMED SRN
- IE-MF-000004597
Sources (1)
- EUDAMED 8d7d093a-c367-486f-aa9f-8fa91a2e83cd 61 fields · synced May 23, 2026