Identity
- Trade Name
- Aerogen® Go EUDAMED
- Device Name
- Mask (Paediatric) EUDAMED
- Model / Reference
- DP-M002 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04719873130320 EUDAMED
- Basic UDI-DI
- B-04719873130320 EUDAMED
- EMDN Code
- R030180 RESPIRATORY MASKS - ACCESSORIES NOT INCLUDED IN OTHER CLASSES 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-04719873130320 | 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 (1)
- EUDAMED ffe59500-d15a-4db8-9536-31101888a8ab 61 fields · synced May 22, 2026