← Back to catalogue

Aerogen USB Controller

EUDAMED

Class 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 EUDAMED
AG-UC1000-SE EUDAMED
AG-UC1000-SC EUDAMED
AG-UC1000-NE EUDAMED

Identifiers

Primary DI / UDI-DI
05391517937923 EUDAMED
05391517937800 EUDAMED
05391517937954 EUDAMED
05391517937961 EUDAMED
Basic UDI-DI
539151793AG00003WE EUDAMED
Direct Marketing DI
05391517936872 EUDAMED
EMDN Code
R060101 COLD NEBULISATION SYSTEMS EUDAMED

Classification

Device Class
Class IIb EUDAMED
Class I EUDAMED
Market of Registration
Czechia EUDAMED
Cyprus EUDAMED
Denmark EUDAMED
Poland EUDAMED
Croatia 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

Is this your device? Claim it to add documentation and request validation.

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