Identity
- Trade Name
- QFR EUDAMED
- Device Name
- Medis QFR XA EUDAMED
- Model / Reference
- 2022 EUDAMEDMedis QFR XA 2022 EUDAMED
Identifiers
- Primary DI / UDI-DI
- B141MEDISQFRXA20220 EUDAMED
- Basic UDI-DI
- ++B141MEDISQFRXA2022J7 EUDAMED
- Direct Marketing DI
- B141MEDISQFRXA20220 EUDAMED
- EMDN Code
- Z12050582 CARDIAC OUTPUT MEASUREMENT INSTRUMENTS - SOFTWARE ACCESSORIES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Special Device Type
- Software 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
Qfr by Medis Medical Imaging Systems bv — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
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 | ++B141MEDISQFRXA2022J7 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Medis Medical Imaging Systems bv
- EUDAMED SRN
- NL-MF-000002670
Sources (1)
- EUDAMED c5fb99a8-8df2-4975-8197-39d6ecc8fab3 61 fields · synced Jun 19, 2026