Identity
- Trade Name
- Central Station EUDAMEDFDA UDI
- Generic Name
- Centralized patient monitor FDA UDI
- Device Name
- Central Station EUDAMEDCentral Station is a network device, intended to display, record and print monitored physiological data from Nihon Kohden bedside monitors, telemetry receiver and/or transmitters. FDA UDI
- Model / Reference
- NA EUDAMEDCNSCS-001 FDA UDI
- Description
- Central Station is a network device, intended to display, record and print monitored physiological data from Nihon Kohden bedside monitors, telemetry receiver and/or transmitters. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00851725007399 EUDAMEDFDA UDI
- Basic UDI-DI
- 0851725007CNSCS-001Y7 EUDAMED
- 510(k) Number
- K242750 FDA UDI
- FDA Product Code
- MSX FDA UDIMHX FDA UDIDRQ FDA UDIMWI FDA UDI
- EMDN Code
- Z12030201 CENTRAL INFORMATION COMPUTING SYSTEMS EUDAMED
- GMDN Term
- Centralized patient monitor FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 870.2300 FDA UDI870.1025 FDA UDI870.2060 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
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Central Station by Nihon Kohden Digital Health Solutions LLC — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA GUDID, FDA 510(k)
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 | K242750 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 0851725007CNSCS-001Y7 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Nihon Kohden Digital Health Solutions LLC
- EUDAMED SRN
- US-MF-000042132
- Authorised Representative
- NIHON KOHDEN EUROPE GmbH DE-AR-000010740
Sources (3)
- EUDAMED 518b26d4-4fb5-4685-955c-1a2c54fccc2f 61 fields · synced Jul 29, 2026
- FDA UDI a819a8c0-31b0-4e27-8d43-feea29fa5363 35 fields · synced May 30, 2026
- FDA 510(k) K242750 1 fields · synced May 18, 2026