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Sign in to claim this brandNihon Kohden Digital Health Solutions LLC
United States·US-MF-000042132
Last updated May 30, 2026
What Nihon Kohden Digital Health Solutions LLC makes
Nihon Kohden Digital Health Solutions LLC manufactures centralized patient monitoring systems designed for hospital-wide data aggregation, including multi-parameter bedside monitors for real-time vital sign tracking. Their portfolio also includes administrative software applications for risk management and networked remote monitoring stations to support decentralized patient observation across care settings.
The company’s devices are classified under FDA regulations as Class II and Class IIa, with corresponding entries in the EU’s eudamed database and the FDA’s Unique Device Identifier (UDI) system. The manufacturer is based in the United States.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Nihon Kohden Digital Health Solutions LLC manufacture?
Nihon Kohden Digital Health Solutions LLC specializes in centralized patient monitoring systems, including centralized patient monitors that aggregate data across hospital networks, and general-purpose multi-parameter bedside monitors for real-time tracking of vital signs like heart rate, blood pressure, and oxygen levels. Their portfolio also includes administrative risk-management software applications designed to support clinical decision-making and networked remote monitoring stations for decentralized patient observation in various care settings.
Where is Nihon Kohden Digital Health Solutions LLC based?
The company is headquartered in the United States, where it develops and distributes its medical devices for use in healthcare environments.
Which regulatory registries list devices manufactured by Nihon Kohden Digital Health Solutions LLC?
Devices from Nihon Kohden Digital Health Solutions LLC are listed in the EU’s eudamed database and the FDA’s Unique Device Identifier (UDI) system, ensuring traceability and compliance tracking under respective regulatory frameworks.
How are the devices manufactured by Nihon Kohden Digital Health Solutions LLC classified under FDA regulations?
The company’s devices fall under FDA Class II and Class IIa classifications, which typically require special controls to ensure their safety and effectiveness. This classification reflects their role in monitoring patient vitals and supporting clinical workflows, where moderate risk is associated with improper use or failure.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- United States
- Address
- 14, Bunsen, Irvine, United States
- Website
- www.nkdhs.com/
- —
- —
- [email protected]
- Phone
- 19495773849
- PRRC Contact
- Arthur Webb
- EUDAMED SRN
- US-MF-000042132
- FDA FEI Number
- —
- DUNS Number
- 126381560
Catalogue (31)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Next Generation NetKonnect | NGNK-6804-T | FDA UDI | Class II | Active |
| Next Generation NetKonnect | NGNK-6803-T | FDA UDI | Class II | Active |
| Prefense | EDNS-WS24 | FDA UDI | Class II | Active |
| Remote Network Station | RNS-6803-7480-U | FDA UDI | Class II | Active |
| Remote Network Station | RNS-6803-7460 | FDA UDI | Class II | Active |
| Remote Network Station | RNS-6804-7490-U | FDA UDI | Class II | Active |
| Remote Network Station | RNS-6803-7490-U | FDA UDI | Class II | Active |
| Next Generation NetKonnect | NGNK-6804-M | FDA UDI | Class II | Active |
| Remote Network Station | RNS-6804-7470 | FDA UDI | Class II | Active |
| NetKonnect | BS-984P | FDA UDI | Class II | Active |
| NetKonnect | QP-985P | FDA UDI | Class II | Active |
| Next Generation NetKonnect | NGNK-6803 | FDA UDI | Class II | Active |
| Remote Network Station | RNS-6804-7480 | FDA UDI | Class II | Active |
| Remote Network Station | RNS-6803-7490 | FDA UDI | Class II | Active |
| Prefense | EDNS-9001-AVGH977 | FDA UDI | Class II | Active |
| Prefense | EDNS-9001 | FDA UDI | Class II | Active |
| NetKonnect | BS-983P | FDA UDI | Class II | Active |
| Remote Network Station | RNS-6803-7470 | FDA UDI | Class II | Active |
| Remote Network Station | RNS-6804-7480-U | FDA UDI | Class II | Active |
| Next Generation NetKonnect | NGNK-6804 | FDA UDI | Class II | Active |
| Remote Network Station | RNS-6804-7490 | FDA UDI | Class II | Active |
| NetKonnect | BS-981P | FDA UDI | Class II | Active |
| NetKonnect | BS-982P | FDA UDI | Class II | Active |
| Next Generation NetKonnect | NGNK-6801 | FDA UDI | Class II | Unknown |
| Next Generation NetKonnect | NGNK-6803-M | FDA UDI | Class II | Active |
| Remote Network Station | RNS-6803-7480 | FDA UDI | Class II | Active |
| Remote Network Station | RNS-6804-7460 | FDA UDI | Class II | Active |
| NetKonnect | QP-983P | FDA UDI | Class II | Active |
| NetKonnect Surveillance | NA | EUDAMED | Class IIa | Active |
| Next Generation NetKonnect | K220989 | FDA 510(k) | Class II | Active |
| Central Station | NA | EUDAMEDFDA UDI | Class IIa | Active |
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