Identity
- Trade Name
- ArtiQ.Spiro EUDAMED
- Device Name
- ArtiQ.PFT EUDAMED
- Model / Reference
- N/A EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05419980057617 EUDAMED
- Basic UDI-DI
- 54199800576ArtiQ.PFT1HQ EUDAMED
- Direct Marketing DI
- 05419980057617 EUDAMED
- EMDN Code
- R9099 RESPIRATORY AND ANAESTHESIA DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Special Device Type
- Software EUDAMED
- Market of Registration
- Belgium 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: Pulmonary function analysis system, adult
ArtiQ.Spiro by ArtiQ NV — 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 | 54199800576ArtiQ.PFT1HQ | Class IIa | Active |
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Manufacturer
- Manufacturer
- ArtiQ NV
- EUDAMED SRN
- BE-MF-000000314
Sources (1)
- EUDAMED 7a8a427f-1b0c-4e01-be4f-1e4e1ef27edb 61 fields · synced Jul 14, 2026