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Aerogen USB Controller
EUDAMEDClass IIb (EU MDR)
Ref AG-UC1000-CERef AG-UC1000-SERef AG-UC1000-SCRef AG-UC1000-NE
by Aerogen Ltd
Identity
- Trade Name
- Aerogen USB Controller EUDAMED
- Device Name
- Aerogen USB Controller EUDAMED
- Model / Reference
- AG-UC1000-CE EUDAMEDAG-UC1000-SE EUDAMEDAG-UC1000-SC EUDAMEDAG-UC1000-NE EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05391517937923 EUDAMED05391517937800 EUDAMED05391517937954 EUDAMED05391517937961 EUDAMED
- Basic UDI-DI
- 539151793AG00003WE EUDAMED
- Direct Marketing DI
- 05391517936872 EUDAMED
- EMDN Code
- R060101 COLD NEBULISATION SYSTEMS EUDAMED
Classification
- Device Class
- Class IIb EUDAMEDClass I EUDAMED
- Market of Registration
- Czechia EUDAMEDCyprus EUDAMEDDenmark EUDAMEDPoland EUDAMEDCroatia 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 (7)
- EUDAMED 2227ff7f-9319-4f6e-833a-8aa6c6159400 61 fields · synced Jul 27, 2026
- EUDAMED ae334bef-1abf-4782-a910-20bdba8b909e 61 fields · synced May 18, 2026
- EUDAMED 9782e6c9-c53b-4895-8c04-1138abdff878 61 fields · synced May 18, 2026
- EUDAMED 5436637f-9ee9-4931-8d39-7c98a21b7d70 61 fields · synced Jul 13, 2026
- EUDAMED d1819f29-30c4-4f38-a0fd-1e70a6e5a10b 61 fields · synced Jul 15, 2026
- EUDAMED af88f8e3-bb57-40f4-914d-34ed5a92ea53 61 fields · synced Jul 24, 2026
- EUDAMED 3075f82c-f880-4e6a-abcc-f2ead381bc13 61 fields · synced Jul 27, 2026