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Singapore HSA registration DE0505854

Nihon Kohden NKV-550 Series Ventilator System

Singapore flagSingapore·CLASS C·Nihon Kohden OrangeMed, LLC·Registered June 09, 2021
Device classification
Device Class
CLASS C
Medical Speciality Area
General Hospital
Registration information
Registration Number
DE0505854
Registration Date
June 09, 2021
Change Notification Approval Date
May 12, 2024
Retention Due Date
June 08, 2025
Product description
The Nihon Kohden NKV-550 Series Ventilator System is intended to provide continuous ventilation for adult, pediatric and neonatal patients who require invasive or noninvasive respiratory support. The NKV-550 offers mandatory and spontaneous ventilation modes as well as respiratory monitoring. The NKV-550 is intended for use in hospitals and hospital-type facilities, as well as, for in-hospital transportation.
Product Owner
Name
Nihon Kohden OrangeMed, LLC
Short Name
Nihon Kohden OrangeMed, LLC
Address
1800 E. Wilshire Avenue, Santa Ana, CA 92705, UNITED STATES
Registrant
Name
Nihon Kohden Singapore Pte Ltd
Address
1 MARITIME SQUARE, HARBOURFRONT CENTRE, #10-34, SINGAPORE 099253
Importer
Name
NIHON KOHDEN SINGAPORE PTE LTD
Address
1 MARITIME SQUARE, HARBOURFRONT CENTRE, #10-34, SINGAPORE 099253
Model information
Model Name(s)
Cable Assy, Main To Remote Console NKV-550 Graphic User Interface O2 ISO White Hose Assembly, DISS (F) X DISS (F), 8 Ft Air ISO Black/White Hose Assembly, DISS (F) X DISS (F), 8 Ft NFS Sensor Module NKV-550 Series Ventilator System NKV-550 Series Ventilator System NKV-550 Series Ventilator System
Model Identifier(s)
CBL5522A DSP5500A HOS5529P HOS5530P NFS5507A NKV-550-N NKV-550-S NKV-550-U
About this record

Access comprehensive regulatory information for Nihon Kohden NKV-550 Series Ventilator System in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0505854 and owned by Nihon Kohden OrangeMed, LLC. The device was registered on June 09, 2021.

This page provides complete registration details including product owner information, registrant details, importer information, and regulatory compliance data from the official Singapore HSA medical device database. Pure Global AI offers free access to Singapore's complete medical device registry, helping global MedTech companies navigate HSA regulations efficiently.

Free DatabasePowered by Pure Global AIHSA Official DataCLASS C