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Nonin® Digital Pulse Oximeter - HSA Registration DE0017339

Access comprehensive regulatory information for Nonin® Digital Pulse Oximeter in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0017339 and owned by Nonin Medical, Inc.. The device was registered on July 21, 2015.

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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CLASS C
DE0017339
Nonin® Digital Pulse Oximeter
HSA Registration Number: DE0017339
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Product Description

The Nonin® Digital Pulse Oximeter is a portable, tabletop device indicated for use in simultaneously measuring, displaying, and recording functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate of adult, pediatric, infant, and neonatal patients. It is intended for spot-checking and/or continuous monitoring of patients during motion and no-motion conditions, and for patients who are well or poorly perfused.

Device Classification
Device Class
CLASS C
Medical Speciality Area
General Hospital
HSA Product Code
Refer to CRPNS
HS Code
90181900
Registration Information
Registration Number
DE0017339
Registration Date
July 21, 2015
Change Notification Approval Date
February 12, 2022
Retention Due Date
July 20, 2025
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)
Sensor, Disposable, Adult, 45cm Cable Sensor, Disposable, Infant, 90cm Cable Sensor, Disposable, Neonate, 90cm Cable Sensor, Disposable, Pediatric, 45cm Cable Sensor, Disposable, Adult Analog output cable (unterminated) – 6 feet / 2 meters Battery Pack Serial Download Cable Power Supply – OUS only Nonin® Model 7500 Digital Pulse Oximeter Adult Articulated Internal Spring Finger Clip, 2m cable Adult Articulated Internal Spring Finger Clip, 3m cable Pediatric External Spring Finger Clip, 1m Pediatric External Spring Finger Clip, 3m Adult Flex, 1m Adult Flex, 3m Ear Clip, 1m Neonatal Flex, 1m Infant Flex, 1m Deluxe 5 point rolling stand w/adjustable pole height Standard 5 point rolling stand w/adjustable pole height Pole Mount Clamp Extension Cable – 3 feet / 1 meter Extension Cable – 10 feet / 3 meter Extension Cable – 20 feet / 6 meter Extension Cable – 30 feet / 9 meter nVISION®
Model Identifier(s)
6000CA 6000CI 6000CN 6000CP 6500MA 7500A 7500B 7500SC 7800PS(6527-000) 7926-001 8000AA-2 8000AA-3 8000AP 8000AP-3 8000J 8000J-3 8000Q2 8001J 8008J Avant RS-D Avant RS-S PC UNI-EXT-1 UNI-EXT-3 UNI-EXT-6 UNI-EXT-9  nVISION®