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High Flow Heated Respiratory Humidifier
EUDAMEDClass IIb (EU MDR)
Ref NF2Ref NF3
Identity
- Trade Name
- High Flow Heated Respiratory Humidifier EUDAMED
- Device Name
- High Flow Heated Respiratory Humidifier EUDAMED
- Model / Reference
- NF2 EUDAMEDNF3 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06945429021356 EUDAMED06945429021363 EUDAMED
- Basic UDI-DI
- B-06945429021356 EUDAMEDB-06945429021363 EUDAMED
- EMDN Code
- R060201 ACTIVE VENTILATION HUMIDIFICATION SYSTEMS, EUDAMEDR060202 OXYGEN ADMINISTRATION HUMIDIFICATION SYSTEMS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Ireland EUDAMEDFinland 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
EUDAMEDEUDAMED
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-06945429021356 | 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 (2)
- EUDAMED 4f382c75-04ac-47c4-9c5b-d53b2e3b90bf 61 fields · synced Oct 6, 2026
- EUDAMED 036d883b-1558-444f-a3d4-b0beb73fce09 61 fields · synced May 18, 2026