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HiFRes series high flow heated respiratory humidifiers
EUDAMEDClass IIa (EU MDR)
Ref HF7Model HF8; HF7; HF6; HF8M
Identity
- Trade Name
- HiFRes series high flow heated respiratory humidifiers EUDAMED
- Device Name
- High Flow Heated Respiratory Humidifiers EUDAMED
- Model / Reference
- HF8; HF7; HF6; HF8M EUDAMEDHF7 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06958949915081 EUDAMED
- Basic UDI-DI
- 6958949930JF EUDAMED
- Direct Marketing DI
- 06958949915081 EUDAMED
- EMDN Code
- R060202 OXYGEN ADMINISTRATION HUMIDIFICATION SYSTEMS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Northern 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
HiFRes series high flow heated respiratory humidifiers by Hunan Beyond Medical Technology Co., Ltd. — Class IIa — MDR — listed in EUDAMED
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 | 6958949930JF | Class IIa | Active |
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Manufacturer
- Manufacturer
- Hunan Beyond Medical Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000002143
- Authorised Representative
- Wellkang Ltd XI-AR-000001836
Sources (1)
- EUDAMED 8b6c137c-bc2e-4175-9b40-659ed1556bed 61 fields · synced Jun 19, 2026