Identity
- Trade Name
- HI-Flow Star System EUDAMED
- Model / Reference
- 308040XK19Z000 EUDAMEDMP05601 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04048675557807 EUDAMED
- Basic UDI-DI
- 040486751308040XK19Z000EF EUDAMED
- EMDN Code
- R020107 THERMOREGULATED BREATHING CIRCUITS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Germany 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
Category: Ventilator breathing circuit, single-use
HI-Flow Star System by Drägerwerk AG & Co. KGaA — Class IIb — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | 040486751308040XK19Z000EF | Class IIb | Active |
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Manufacturer
- Manufacturer
- Drägerwerk AG & Co. KGaA
- EUDAMED SRN
- DE-MF-000005329
Sources (1)
- EUDAMED 07812cf2-d8ba-459c-9790-a379d157ada0 61 fields · synced Jul 17, 2026