Identity
- Trade Name
- Respiratory Humidifier EUDAMED
- Device Name
- Respiratory Humidiifer EUDAMED
- Model / Reference
- HT50 EUDAMEDHT30 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06945429029628 EUDAMED06945429029611 EUDAMED
- Basic UDI-DI
- 69454290RH001NV EUDAMED
- Direct Marketing DI
- 06945429029628 EUDAMED06945429029611 EUDAMED
- EMDN Code
- R060201 ACTIVE VENTILATION HUMIDIFICATION SYSTEMS, EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Ireland 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
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Respiratory Humidifier by Shenzhen Comen Medical Instruments Co., LTD. — Class IIa — 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 | 69454290RH001NV | Class IIa | Active |
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Manufacturer
- Manufacturer
- Shenzhen Comen Medical Instruments Co., LTD.
- EUDAMED SRN
- CN-MF-000002236
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (2)
- EUDAMED 20f687a3-4dcb-4899-8b0a-4fd0d3284a24 61 fields · synced Oct 6, 2026
- EUDAMED 4582f42b-934f-497c-a46d-eb24c37ecf2e 61 fields · synced May 17, 2026