Identity
- Trade Name
- High Flow Heated Respiratory Humidifier EUDAMED
- Device Name
- High Flow Heated Respiratory Humidifier EUDAMED
- Model / Reference
- NF5 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06945429021370 EUDAMED
- Basic UDI-DI
- B-06945429021370 EUDAMED
- EMDN Code
- R060102 HOT NEBULISATION SYSTEMS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Finland 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
No
EUDAMED
Measuring Function
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
High Flow Heated Respiratory Humidifier by Shenzhen Comen Medical Instruments Co., LTD. — Class IIb — 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-06945429021370 | Class IIb | 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 (1)
- EUDAMED b430df98-7ec8-48cd-8bfa-90c615349d53 61 fields · synced Jun 18, 2026