← Back to catalogue

Aerogen® Go

EUDAMED

Class IIa (EU MDR)

Ref DP-M002Ref DP-M001Ref DP-P001

by HCmed Innovations Co., Ltd.

Identity

Trade Name
Aerogen® Go EUDAMED
Device Name
Mask (Paediatric) EUDAMED
Mask (Adult) EUDAMED
Mouthpiece EUDAMED
Model / Reference
DP-M002 EUDAMED
DP-M001 EUDAMED
DP-P001 EUDAMED

Identifiers

Primary DI / UDI-DI
04719873130245 EUDAMED
04719873130269 EUDAMED
04719873130238 EUDAMED
04719873130337 EUDAMED
04719873130283 EUDAMED
04719873130313 EUDAMED
Basic UDI-DI
B-04719873130245 EUDAMED
B-04719873130269 EUDAMED
B-04719873130238 EUDAMED
B-04719873130337 EUDAMED
B-04719873130283 EUDAMED
B-04719873130313 EUDAMED
EMDN Code
R03010301 AEROSOL THERAPY MASKS EUDAMED
R030180 RESPIRATORY MASKS - ACCESSORIES NOT INCLUDED IN OTHER CLASSES EUDAMED
R9001 RESPIRATORY MOUTHPIECES EUDAMED

Classification

Device Class
Class IIa EUDAMED
Market of Registration
Germany EUDAMED

Clinical & Handling

Sterile

No

EUDAMED

Implantable

No

EUDAMED

Reusable

No

EUDAMED

Contains Latex

No

EUDAMED

Reprocessed

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Administering Medicine

Yes

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

Aerogen® Go by Hcmed Innovations Co., Ltd. — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/MDD

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

Manufacturer

Manufacturer
HCmed Innovations Co., Ltd.
EUDAMED SRN
TW-MF-000011348
Authorised Representative
MDSS GmbH DE-AR-000005430

Sources (8)

  • EUDAMED b1fede1d-824b-4f57-9d54-bdf32939f89e 61 fields · synced Jul 20, 2026
  • EUDAMED 9b98675b-2a43-4e5c-b43d-6bf8cd6985bd 61 fields · synced May 16, 2026
  • EUDAMED 8079a43c-9dca-4be9-ab0d-bbd8cc4a9d9c 61 fields · synced May 17, 2026
  • EUDAMED 23784216-f31a-48a6-8b5f-19e0f9811f61 61 fields · synced May 17, 2026
  • EUDAMED f5f0e497-f843-4af5-bc98-f83ad50cb714 61 fields · synced May 19, 2026
  • EUDAMED b1724d9b-629d-44f6-a100-8ef2a07f22d4 61 fields · synced May 19, 2026
  • EUDAMED 40583329-fd33-4924-9e5f-fea2852fbbf6 61 fields · synced Jul 9, 2026
  • EUDAMED b352eb8b-2a3d-4c4f-b058-b9e64d9ac96e 61 fields · synced Jul 20, 2026