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NONIN MEDICAL, INC.

USA · Plymouth

✓ Record-verifiedregistrations found in 9 markets

This company has registrations in United States, Brazil, Canada, Taiwan, Singapore, South Korea, Australia, Hong Kong, Israel — 9 overseas markets. The China NMPA lookup is still pending.

Registrations by market

Each market counts a different unit; figures are not directly comparable

CNChinaNMPA

n/aThis registry lists domestic registrants only

EUEuropean UnionEUDAMED

pendingnot queried

USUnited StatesFDA openFDA

7listed device types

Class I 1Class II 6Class III 0

plus 33 registration records and 50 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

0registered devices

4 including historic records

SASaudi ArabiaSFDA

0registered imported devices

low-risk imported devices only; a 2023 snapshot, not updated since

CACanadaMDALL

15active device licences

Class III 15

31 including historic records

TWTaiwanTFDA

7valid device licences

Class II 7

SGSingaporeHSA SMDR

8device registrations

CLASS B 2CLASS C 6

KRSouth KoreaMFDS GMP

2GMP quality-system certificates

Import 2

AUAustraliaTGA ARTG

22active ARTG entries

Class I 3IIa 1IIb 18

HKHong KongMDACS

8valid listings

Class III 8

ILIsraelAMAR

5registrations

RURussiaRoszdravnadzor

pendingnot queried

Not yet connected: India CDSCO, Indonesia Kemenkes. The public search for Japan PMDA and Vietnam IMDA does not return manufacturer names, so entries cannot be linked to companies coming — where there is no data it is shown as "pending", never estimated.

How these numbers were verified

record-verified

Company-name search in every official database is a substring match and returns same-named but different companies. Each figure below is the count after re-checking every record against the manufacturer name.

United States33 registration records, 50 510(k), 0 PMA

Canada15 confirmed, 0 excluded

Manufacturer names merged into this page: NONIN MEDICAL, INC. · NONIN MEDICAL INC. · NONIN MEDICAL, INC

FDA 510(k) clearances by year

11999

32000

12002

22003

42004

52005

12006

32007

22008

32009

42010

22012

12013

22014

12015

22016

12018

22019

12020

12024

FDA listed device types

System, Measurement, Blood-Pressure, Non-Invasive 1Oximeter, Ear 1Oximeter, Tissue Saturation 1Oximeter, Wellness 1Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase 1Oximeter 1Medical Device Data System 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K211498	Nonin OTC Pulse Oximeter Model 3250	2024-11-13
US	K192900	H500 Multi-Sensing Oximetry System	2020-06-29
US	K191403	Pulse Oximeter	2019-12-20
CA	11776	8800 CARDIORESPIRATORY PULSE OXIMETER	Class III
CA	13757	PULSE OXIMETER W/CARBON DIOXIDE DETECTOR	Class III
CA	30302	MODEL 8600 PULSE OXIMETER	Class III

NONIN MEDICAL, INC.

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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