Identity
- Trade Name
- Qflow EUDAMED
- Device Name
- Qflow EUDAMED
- Model / Reference
- Qflow EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03760253450188 EUDAMED
- Basic UDI-DI
- B-03760253450188 EUDAMED
- EMDN Code
- Z12150185 SPIROMETRY INSTRUMENTS - CONSUMABLES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- France EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Pulmonary function testing filter/mouthpiece
Qflow by FIM Medical — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-03760253450188 | Class IIa | Active |
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Manufacturer
- Manufacturer
- FIM Médical
- EUDAMED SRN
- FR-MF-000017090
Sources (1)
- EUDAMED a38e2318-b08d-4196-b055-595cc4bdc665 61 fields · synced May 29, 2026