Identity
- Trade Name
- Medication chamber inhaler EUDAMED
- Device Name
- Medication chamber inhaler EUDAMED
- Model / Reference
- HY-033-2M EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975834950842 EUDAMED
- Basic UDI-DI
- 697583495GQ6X EUDAMED
- EMDN Code
- R060101 COLD NEBULISATION SYSTEMS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany 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
Medication chamber inhaler by Ningbo Hanyue Medical Technology CO., LTD. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 697583495GQ6X | Class I | Active |
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Manufacturer
- Manufacturer
- Ningbo Hanyue Medical Technology CO., LTD.
- EUDAMED SRN
- CN-MF-000035941
- Authorised Representative
- MedPath GmbH DE-AR-000000087
Sources (1)
- EUDAMED a0eb8387-6683-4e29-9cc4-8f354ef970a1 61 fields · synced Jun 18, 2026