Identity
- Trade Name
- COMFORT HI-FLOW EUDAMED
- Device Name
- High flow heated respiratory humidifier EUDAMED
- Model / Reference
- CF10 EUDAMEDH20000 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08809517012016 EUDAMED
- Basic UDI-DI
- 951701ComfortHiFlowEB EUDAMED
- Direct Marketing DI
- 08809517012016 EUDAMED
- EMDN Code
- R060202 OXYGEN ADMINISTRATION HUMIDIFICATION SYSTEMS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Spain 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
Comfort Hi-Flow by Seoil Pacific Corp. — 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 | 951701ComfortHiFlowEB | Class IIa | Active |
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Manufacturer
- Manufacturer
- Seoil Pacific Corp.
- EUDAMED SRN
- KR-MF-000012478
- Authorised Representative
- Advena Limited MT-AR-000000234
Sources (1)
- EUDAMED 5e5f8a88-99d7-4f02-b6cc-6c142262b281 61 fields · synced Jul 14, 2026