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Medis QFR XA
EUDAMEDClass IIa (EU MDR)
Ref MEDISQFRXAModel Medis QFR XARef 20220504Ref 9.51.450.2025
Identity
- Trade Name
- Medis QFR XA EUDAMEDMedis EUDAMEDQFR EUDAMED
- Device Name
- Medis QFR XA EUDAMEDMedis Suite 2022 EUDAMED
- Model / Reference
- Medis QFR XA EUDAMEDMEDISQFRXA EUDAMED20220504 EUDAMED9.51.450.2025 EUDAMED
Identifiers
- Primary DI / UDI-DI
- +B141MEDISQFRXA0 EUDAMEDMEDISSUITE2022 EUDAMEDMEDISQFRXA20250 EUDAMED
- Basic UDI-DI
- ++B141MEDISQFRXAJN EUDAMEDB-MEDISSUITE2022 EUDAMED
- Direct Marketing DI
- +B141MEDISQFRXA0 EUDAMEDMEDISQFRXA20250 EUDAMED
- EMDN Code
- Z12050582 CARDIAC OUTPUT MEASUREMENT INSTRUMENTS - SOFTWARE ACCESSORIES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Netherlands 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
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Medis QFR XA by Medis Medical Imaging Systems bv — Class IIa — MDD, MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | ++B141MEDISQFRXAJN | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | ++B141MEDISQFRXAJN | Class IIa | Active |
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Manufacturer
- Manufacturer
- Medis Medical Imaging Systems bv
- EUDAMED SRN
- NL-MF-000002670
Sources (3)
- EUDAMED ac787519-4633-4cd5-b736-3ba765666210 61 fields · synced Jul 25, 2026
- EUDAMED 5ca60230-5bd7-4464-b257-d48a79a5639e 61 fields · synced May 17, 2026
- EUDAMED f1ea6adf-1407-4287-953c-18f68bd83b2a 61 fields · synced Jul 11, 2026