Pure Global

Nonin® Onyx® Vantage 9590 Finger Pulse Oximeter - HSA Registration DE0017954

Access comprehensive regulatory information for Nonin® Onyx® Vantage 9590 Finger Pulse Oximeter in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0017954 and owned by Nonin Medical, Inc.. The device was registered on March 17, 2016.

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 Database
Powered by Pure Global AI
HSA Official Data
CLASS B
DE0017954
Nonin® Onyx® Vantage 9590 Finger Pulse Oximeter
HSA Registration Number: DE0017954
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
Product Description

The intended use to The Nonin® Onyx Vantage 9590 Finger Pulse Oximeter is a small,lightweight,portable device indicated for use in measuring and displaying functional oxygen saturation of arterial haemoglobin (%SpO2)and pulse rate of patients who are well or poorly perfused.It is intended for spot-checking of adult and pediatric patients on digits(fingers,thumb,toes) that are between 0.3-1.0 inch(0.8-2.5cm) thick

Device Classification
Device Class
CLASS B
Medical Speciality Area
General Hospital
HSA Product Code
Refer to CRPNS
HS Code
90181900
Registration Information
Registration Number
DE0017954
Registration Date
March 17, 2016
Change Notification Approval Date
July 31, 2020
Retention Due Date
March 16, 2026
Product Owner
Short Name
Nonin Medical, Inc.
Address
13700 1st Avenue North, Plymouth, MN 55441, UNITED STATES
Registrant
Address
4 LENG KEE ROAD, SIS BUILDING, #03-03, SINGAPORE 159088
Importer
Address
4 LENG KEE ROAD, SIS BUILDING, #03-03, SINGAPORE 159088
Model Information
Model Name(s)
Lanyard, GO2-L Onyx Vantage Model 9590 Oximeter Onyx Vantage Model 9590 Oximeter Onyx Vantage Model 9590 Oximeter Onyx Vantage Model 9590 Oximeter
Model Identifier(s)
6918-000 8195-001 8195-002 8195-003 8195-004