Identity
- Trade Name
- Aerogen® Go EUDAMED
- Device Name
- Vibrating Mesh Nebulizer EUDAMED
- Model / Reference
- HCM-86C EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04719873130306 EUDAMED
- Basic UDI-DI
- B-04719873130306 EUDAMED
- EMDN Code
- R030180,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-04719873130306 | Class IIa | Active |
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 (1)
- EUDAMED 2b7b846f-21f1-4947-8701-0ba4154dd764 61 fields · synced May 22, 2026