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Cercare Medical Neurosuite
EUDAMEDFDA UDIFDA 510(k)Class IIa (EU MDR)
Ref Cercare Medical Neurosuite ver.18510(k) K230016Ref Cercare Medical Neurosuite ver.16
Identity
- Trade Name
- Cercare Medical Neurosuite EUDAMEDFDA UDI
- Generic Name
- Radiological PACS software FDA UDI
- Device Name
- Cercare Medical Neurosuite EUDAMEDCercare Medical Neurosuite ver. 16 FDA UDI
- Model / Reference
- Cercare Medical Neurosuite ver.18 EUDAMEDCercare Medical Neurosuite ver.16 EUDAMED16 FDA UDI
- Description
- Cercare Medical Neurosuite ver. 16 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05745000308316 EUDAMED05745000308200 EUDAMEDFDA UDI
- Basic UDI-DI
- 5745000308CMNNEUROSUITEL7 EUDAMED
- Direct Marketing DI
- 05745000308316 EUDAMED05745000308200 EUDAMED
- 510(k) Number
- K202793 FDA UDI
- FDA Product Code
- LLZ FDA UDI
- EMDN Code
- Z110603 PICTURE ARCHIVING AND COMMUNICATION SYSTEMS EUDAMED
- GMDN Term
- Radiological PACS software FDA UDI
Classification
- Device Class
- Class IIa 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
Cercare Medical Neurosuite by Cercare Medical A/S — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA GUDID, FDA 510(k) — regulatory data on deviCERTS
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 | K230016 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 5745000308CMNNEUROSUITEL7 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Cercare Medical A/S
- EUDAMED SRN
- DK-MF-000002148
Sources (4)
- EUDAMED 40381088-19a9-4cc9-8bab-a2742e3abe88 85 fields · synced Oct 6, 2026
- FDA UDI 5d41b269-068a-40ce-9029-c5d45514793e 34 fields · synced May 30, 2026
- EUDAMED 6f2105be-9cba-4bb4-85da-0c70dc505f2a 61 fields · synced Jul 21, 2026
- FDA 510(k) K230016 1 fields · synced May 18, 2026