Identity
- Trade Name
- Aerogen® Go EUDAMED
- Device Name
- Vibrating Mesh Nebulizer EUDAMED
- Model / Reference
- HCM-86C EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04719873130221 EUDAMED
- Basic UDI-DI
- B-04719873130221 EUDAMED
- EMDN Code
- R060101 COLD NEBULISATION SYSTEMS EUDAMEDR03010301,R060101,R9001 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
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-04719873130221 | Class IIa | Active |
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Manufacturer
- Manufacturer
- HCmed Innovations Co., Ltd.
- EUDAMED SRN
- TW-MF-000011348
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (2)
- EUDAMED afa73cae-0dca-4b53-8b7d-1f88e226664c 61 fields · synced Oct 5, 2026
- EUDAMED 3583a845-98f3-411e-8b2f-24bf30636c81 61 fields · synced Oct 5, 2026