Identity
- Trade Name
- FlexO2 EUDAMED
- Device Name
- FlexO2 EUDAMED
- Model / Reference
- LF100100 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07350167420009 EUDAMED
- Basic UDI-DI
- 735016742FlexO2W3 EUDAMED
- EMDN Code
- R03010204 OXYGEN ADMINISTRATION TUBINGS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Sweden 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
Yes
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Oxygen administration tubing
FlexO2 by LungFlex AB — Class IIa — 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 | 735016742FlexO2W3 | Class IIa | Active |
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Manufacturer
- Manufacturer
- LungFlex AB
- EUDAMED SRN
- SE-MF-000042297
Sources (1)
- EUDAMED 798f4260-2774-4de4-8141-bad0794e4be6 61 fields · synced Jun 18, 2026