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MeVis Liver Suite
EUDAMEDFDA UDIFDA 510(k)Class IIa (EU MDR)
Ref MVLS 1.3 ROW / MVLS-View 1.3-S ROWModel 1.xRef MVLS-1.2-F / MVLS-1.2-V
Identity
- Trade Name
- MeVis Liver Suite FDA UDI
- Generic Name
- Image segmentation application software FDA UDI
- Device Name
- MeVis Liver Suite EUDAMED
- Model / Reference
- 1.x EUDAMEDMVLS 1.3 ROW / MVLS-View 1.3-S ROW EUDAMEDMVLS-1.2-F / MVLS-1.2-V EUDAMED1.3 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04260483290268 EUDAMEDFDA UDI04260483290138 EUDAMED
- Basic UDI-DI
- 0426048329MVLSXH EUDAMED
- Direct Marketing DI
- 04260483290268 EUDAMED04260483290138 EUDAMED
- 510(k) Number
- K232045 FDA UDI
- FDA Product Code
- JAK FDA UDI
- EMDN Code
- Z11030682 COMPUTED TOMOGRAPHS (CT) - SOFTWARE ACCESSORIES EUDAMED
- GMDN Term
- Image segmentation application software FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 892.1750 FDA UDI
- Special Device Type
- Software EUDAMED
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Full-body CT system
MeVis Liver Suite by Mevis Medical Solutions Ag — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA GUDID, FDA 510(k) — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K232045 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 0426048329MVLSXH | Class IIa | Active |
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Manufacturer
- Manufacturer
- MeVis Medical Solutions AG
- EUDAMED SRN
- DE-MF-000005418
Sources (4)
- EUDAMED 1826e19f-b884-4fee-8e45-1697668b8a5b 61 fields · synced Oct 6, 2026
- EUDAMED d97688d6-de97-4ebe-ba69-eaf2e71e012e 61 fields · synced May 18, 2026
- FDA UDI 860c6ff1-5d65-47c5-9a8c-c4bf73a20629 33 fields · synced May 30, 2026
- FDA 510(k) K232045 1 fields · synced May 18, 2026