Nihon Kohden Ventilator NKV-330 - HSA Registration DE0504672

Access comprehensive regulatory information for Nihon Kohden Ventilator NKV-330 in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0504672 and owned by Nihon Kohden Corporation. The device was registered on July 06, 2020.

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.

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HSA Official Data

CLASS C

DE0504672

Nihon Kohden Ventilator NKV-330

HSA Registration Number: DE0504672

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Product Description

This ventilator uses positive pressure to provide ventilation and ventilatory assistance as well as oxygen administration to adult or pediatric patients who have spontaneous breathing but need mechanical ventilation (patients with a tidal volume of 100mL or more). This ventilator can be used in the ICU, recovery room, ward or transport inside the hospital. This ventilator is intended for use by qualified medical personnel such as physicians, nurses and respiratory therapists.

Device Classification

Device Class

CLASS C

Medical Speciality Area

General Hospital

Registration Information

Registration Number

DE0504672

Registration Date

July 06, 2020

Change Notification Approval Date

November 25, 2024

Retention Due Date

July 05, 2025

Product Owner

Name

Nihon Kohden Corporation

Short Name

Nihon Kohden

Address

1-31-4 Nishiochiai,, Shinjuku-ku, Tokyo 161-8560, JAPAN

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)

CO2 adapter CO2 adapter SpO2 adapter SpO2 adapter Ventilator QS-330Z Flow sensor CO2 sensor CO2 sensor CO2 sensor kit CO2 sensor kit CO2 sensor kit SpO2 probe SpO2 probe SpO2 probe SpO2 probe Finger probe Multi-site probe Multi-site Y probe SpO2 probe SpO2 probe SpO2 probe SpO2 probe SpO2 probe SpO2 probe Finger probe Finger probe Finger probe Finger probe Exhalation port Breathing circuit filter Humidification chamber Single limb breathing set HW-EXH Single limb breathing set WT-EXH Single limb breathing set EXH Single limb breathing set HW NPPV full face mask set L NPPV full face mask set M NPPV full face mask set S NPPV cap-ONE mask set L NPPV cap-ONE mask set M NPPV cap-ONE mask set S Galvanic oxygen sensor Paramagnetic oxygen sensor Internal filter Air intake HEPA filter Air intake dust filter

Model Identifier(s)

JG-900P JG-920P JL-500P1 JL-500P2 NKV-330 QS-330Z TF-300Z TG-101T TG-121T TG-900P TG-920P TG-980P TL-051S TL-052S TL-061S TL-062S TL-201T TL-220T TL-260T TL-271T TL-271T3 TL-272T TL-272T3 TL-273T TL-273T3 TL-630T1 TL-630T3 TL-631T1 TL-631T3 VA-300Z VA-301Z VA-302Z VB-310Z VB-311Z VB-312Z VB-313Z VM-310Z VM-311Z VM-312Z VM-330Z VM-331Z VM-332Z YS-119P4 YS-119P5 YS-119P6 YS-119P7 YS-119P8