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Respironics California, Inc.

USA · Carlsbad

✓ Record-verifiedregistrations found in 7 markets

This company has registrations in United States, Saudi Arabia, Canada, Singapore, Australia, Israel, Russia — 7 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

11510(k) clearances

Class I 0Class II 0Class III 0

plus 0 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

4registered imported devices

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

CACanadaMDALL

15active device licences

Class II 5Class III 10

16 including historic records

TWTaiwanTFDA

0valid device licences

SGSingaporeHSA SMDR

2device registrations

CLASS C 2

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

3active ARTG entries

Class I 1IIb 2

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

1registrations

RURussiaRoszdravnadzor

1active registrations

Class 2b 1

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 States0 registration records, 11 510(k), 0 PMA, 19 excluded

Brazil0 confirmed, 4 excluded

Saudi Arabia4 confirmed, 6 excluded

Canada15 confirmed, 7 excluded

Manufacturer names merged into this page: RESPIRONICS CALIFORNIA LLC · Respironics California LLC · Respironics California, LLC · Respironics California, Inc.

Registration details (sample)

Market	Identifier	Name	Class / date
US	K110083	V200 VENTILATOR WITH APRV MODE, ESPRIT VENTILATOR WITH APRV MODE	2012-01-13
US	K110795	V200 INTELLI-TRAK OPTION	2011-08-19
US	K102054	V200 VENTILATOR	2010-12-22
SA	ME0000008125SFDAA00001	Battery V60	—
SA	ME0000003257SFDAA00004	V60 STAND	—
CA	6901	MODEL 860 TRANSCUTANEOUS CO2/O2 MONITOR SYSTEM	Class II
CA	11136	RESPIRATORY MECHANICS MONITORS	Class III
CA	13706	END TIDAL MONITOR SYSTEM	Class III

Respironics California, Inc.

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

Registration details (sample)

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