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High-flow Humidification Device
EUDAMEDClass IIa (EU MDR)
Ref NAModel Hi-800, Hi-600
Identity
- Device Name
- High-flow Humidification Device EUDAMED
- Model / Reference
- Hi-800, Hi-600 EUDAMEDNA EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975984064512 EUDAMED
- Basic UDI-DI
- 6970341680111901HP EUDAMED
- Direct Marketing DI
- 06975984064512 EUDAMED
- EMDN Code
- R060202 OXYGEN ADMINISTRATION 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
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
High-flow Humidification Device by Shenzhen Lifotronic Technology 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 | 6970341680111901HP | Class IIa | Active |
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Manufacturer
- Manufacturer
- Shenzhen Lifotronic Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000005654
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (2)
- EUDAMED cc1ad7cd-d2b6-422b-95a5-a614178a5168 61 fields · synced Jul 15, 2026
- EUDAMED cc1ad7cd-d2b6-422b-95a5-a614178a5168-1 61 fields · synced Jun 10, 2026