Identity
- Trade Name
- Medis Suite EUDAMEDMedis Suite MRCT EUDAMED
- Device Name
- QAngio XA and QAngio XA 3D EUDAMEDMedis Suite MRCT 2023 EUDAMED
- Model / Reference
- 20240115 EUDAMED
Identifiers
- Primary DI / UDI-DI
- MEDISSUITEXA2023 EUDAMEDMEDISSUITEMRCT2023 EUDAMED
- Basic UDI-DI
- B-MEDISSUITEXA2023 EUDAMEDB-MEDISSUITEMRCT2023 EUDAMED
- EMDN Code
- Z12050582 CARDIAC OUTPUT MEASUREMENT INSTRUMENTS - SOFTWARE ACCESSORIES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Special Device Type
- -1192 EUDAMED
- Market of Registration
- Austria EUDAMEDNetherlands 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
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Medis Suite by Medis Medical Imaging Systems bv — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
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-MEDISSUITEXA2023 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Medis Medical Imaging Systems bv
- EUDAMED SRN
- NL-MF-000002670
Sources (2)
- EUDAMED 53e2d5b5-1145-4a16-894b-b252d700fb56 61 fields · synced Aug 2, 2026
- EUDAMED e758302a-56b7-433b-9e66-6791b9cb9db2 61 fields · synced May 18, 2026