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Respironics Novametrix, Inc.

USA · Andover

✓ Record-verifiedregistrations found in 6 markets

This company has registrations in United States, Canada, Singapore, Australia, Hong Kong, Israel — 6 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

17listed device types

Class I 3Class II 14Class III 0

plus 17 registration records and 11 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

0registered devices

this export covers Class I / II only (the cadastro route)

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

16active device licences

Class II 11Class III 5

26 including historic records

TWTaiwanTFDA

0valid device licences

SGSingaporeHSA SMDR

4device registrations

CLASS B 3CLASS C 1

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

38active ARTG entries

Class I 9IIa 13IIb 16

HKHong KongMDACS

4valid listings

Class II 1Class III 3

ILIsraelAMAR

7registrations

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 States17 registration records, 11 510(k), 0 PMA, 1 excluded

Canada16 confirmed, 0 excluded

Manufacturer names merged into this page: RESPIRONICS NOVAMETRIX, LLC

FDA 510(k) clearances by year

12003

52004 · K042601

12006 · K053174

12008 · K080652

22009 · K092217

12011 · K103578

FDA listed device types

showing 8 of 17

Computer, Diagnostic, Programmable 1Mixer, Breathing Gases, Anesthesia Inhalation 1Detector And Alarm, Arrhythmia 1Spirometer, Monitoring (W/Wo Alarm) 1System, Measurement, Blood-Pressure, Non-Invasive 1Plethysmograph, Impedance 1Electrocardiograph 1Analyzer, Gas, Oxygen, Gaseous-Phase 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K103578	PHILIPS NM3 RESPIRATORY MONITOR WITH VENTASSIST	2011-06-02
US	K092217	MERCURY VCO2	2009-08-21
US	K091459	PHILIPS NM3 MONITOR, MODEL 7900	2009-07-28
CA	6895	TIDALWAVE HANDHELD END TIDAL MONITOR	Class II
CA	12833	WHISPERPAK CPAP RESPIRATORY TREATMENT KITS	Class II
CA	14273	TIDALWAVE SP CAPNOGRAPH UNITS	Class III

Respironics Novametrix, 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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