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Cercare Medical Neurosuite
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref Release 2023-02-01
Identity
- Trade Name
- Cercare Medical Neurosuite EUDAMEDFDA UDI
- Generic Name
- Radiological PACS software FDA UDI
- Device Name
- Cercare Medical Neurosuite EUDAMEDCercare Medical Neurosuite release 2023-02-01 and prior FDA UDI
- Model / Reference
- Release 2023-02-01 EUDAMEDCercare Medical Neurosuite FDA UDI
- Description
- Cercare Medical Neurosuite release 2023-02-01 and prior FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05745000308002 EUDAMEDFDA UDI
- Basic UDI-DI
- 5745000308CMNNEUROSUITEL7 EUDAMED
- Direct Marketing DI
- 05745000308002 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
- Not 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 — 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 | 5745000308CMNNEUROSUITEL7 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Cercare Medical A/S
- EUDAMED SRN
- DK-MF-000002148
Sources (2)
- EUDAMED 173e3a2c-8c90-4871-9bc2-5430baade487 61 fields · synced Jul 14, 2026
- FDA UDI 91d885e6-21d0-4c46-8e12-60c856ff39d1 35 fields · synced May 30, 2026