Identity
- Trade Name
- Virtual Expert EUDAMEDCercare Medical Neurosuite (CMN) Capillary Function with Virtual Expert FDA UDI
- Generic Name
- Radiological PACS software FDA UDI
- Device Name
- Virtual Expert EUDAMEDCercare Medical Neurosuite (CMN) Capillary Function with Virtual Expert ver. 15 FDA UDI
- Model / Reference
- Virtual Expert ver. 15 EUDAMED15 FDA UDI
- Description
- Cercare Medical Neurosuite (CMN) Capillary Function with Virtual Expert ver. 15 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05745000308170 EUDAMEDFDA UDI
- Basic UDI-DI
- 5745000308CMNVIRTUALEXEH EUDAMED
- Direct Marketing DI
- 05745000308170 EUDAMED
- FDA Product Code
- LLZ FDA UDI
- EMDN Code
- Z11030592 RADIOLOGY INSTRUMENTS - MEDICAL DEVICE SOFTWARE EUDAMED
- GMDN Term
- Radiological PACS software FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 892.2050 FDA UDI
- Special Device Type
- Software EUDAMED
- Market of Registration
- Denmark 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
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Virtual Expert by Cercare Medical A/S — Class IIb — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 5745000308CMNVIRTUALEXEH | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
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Manufacturer
- Manufacturer
- Cercare Medical A/S
- EUDAMED SRN
- DK-MF-000002148
Sources (2)
- EUDAMED 7e1c0934-3c12-4349-b24a-bdb23565ec65 61 fields · synced Jun 9, 2026
- FDA UDI f70c741c-4f5c-4834-9c41-e6aa70a22f52 34 fields · synced May 29, 2026