Eu Mdd
Eu Md Class 2a
On The Market
๐ณ๐ฑ Netherlands
Medis Suite
Devices (same UDI-DI)
1
Certificates
1
Countries
19
Notified Bodies
1
Basic Information
- Primary DI
- MEDISSUITEXA2023
- Basic UDI-DI Code
- B-MEDISSUITEXA2023
- Reference
- 20240115
- Device Types
- None provided
- Regulation
- Eu Mdd
- Classification
- Eu Md Class 2a
- Status
- On The Market
- Manufacturer
- Medis Medical Imaging Systems bv
Additional Description
Medis Suite XA is the gold-standard software solution for the quantification of coronary and peripheral vessels in X-ray angiograms. Further, it offers quantitative analyses for the left and right ventricles of the heart in X-ray angiograms. Medis Suite XA enables interventional cardiologists, interventional radiologists and researchers to obtain accurate results that help detect vessel abnormalities and cardiac (dys)function, assess the effectiveness of therapies and devices, and create evidence for treatment reimbursement. Medis Suite XA is used by clinicians, core laboratories and research institutions worldwide.
CND Nomenclature Codes
| Code | Description |
|---|---|
| Z12050582 | CARDIAC OUTPUT MEASUREMENT INSTRUMENTS - SOFTWARE ACCESSORIES |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| MDD Annex II (excluding section 4) | BE19/818843785 | SGS Belgium NV | Expired |
Available In Countries
๐ฆ๐น Austria
๐ง๐ช Belgium
๐จ๐พ Cyprus
๐ฉ๐ช Germany
๐ช๐ธ Spain
๐ซ๐ฎ Finland
๐ซ๐ท France
๐ญ๐ท Croatia
๐ญ๐บ Hungary
๐ฎ๐ช Ireland
๐ฎ๐ธ Iceland
๐ฎ๐น Italy
๐ฑ๐บ Luxembourg
๐ฒ๐น Malta
๐ณ๐ฑ Netherlands
๐ต๐ฑ Poland
๐ต๐น Portugal
๐น๐ท Tรผrkiye
๐ฌ๐ง United Kingdom
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