Identity
- Trade Name
- AirLife DuoTherm™ EUDAMED
- Device Name
- AirLife DuoTherm™ Heated Humidifier, 220-240V EUDAMED
- Model / Reference
- 377HTR220 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 10190752138056 EUDAMED
- Basic UDI-DI
- B-10190752138056 EUDAMED
- EMDN Code
- R0699 NEBULISATION AND HUMIDIFICATION SYSTEMS - OTHER EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
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
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
AirLife DuoTherm™ by Vyaire Medical, Inc. — 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-10190752138056 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Vyaire Medical, Inc.
- EUDAMED SRN
- US-MF-000008254
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (1)
- EUDAMED 5cfffb6c-a8a2-4548-8807-4064ea476a1b 61 fields · synced May 25, 2026