Home›USA›Philips Respironics, Inc.

Philips Respironics, Inc.

USA · Murrysville

✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Canada, Singapore — 3 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

3510(k) clearances

Class I 0Class II 0Class III 0

plus 0 registration records and 3 510(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

58active device licences

Class II 47Class III 11

249 including historic records

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

11device registrations

CLASS B 11

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

pendingnot queried

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 States0 registration records, 3 510(k), 0 PMA, 17 excluded

Brazil0 confirmed, 4 excluded

Saudi Arabia0 confirmed, 9 excluded

Canada58 confirmed, 7 excluded

Manufacturer names merged into this page: RESPIRONICS INC. ALSO TRADING AS PHILIPS RS NORTH AMERICA LLC

Same-named companies — This database also contains companies with near-identical names: RESPIRONICS INC. ALSO TRADING AS PHILIPS RS NORTH AMERICA LLC, Respironics Inc. (Dba Philips Respironics). Company name alone cannot separate their registrations, so the figures below may include either.

Registration details (sample)

Market	Identifier	Name	Class / date
US	K233555	AF531 Oro-Nasal EE Leak 1 Face Mask; AF531 Oro-Nasal EE Leak 2 Face Mask	2024-07-31
US	K140580	REVOLUTION FULLFACE MASK	2015-01-16
US	K111378	OXIMETRY INTERFACE KIT	2011-10-04
CA	12771	NU-MO GARMENTS	Class III
CA	12775	CHEST SHELLS	Class III
CA	13087	BIPAP SYSTEMS AND REMOTE CONTROL UNIT	Class III

Philips Respironics, Inc.

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

Registration details (sample)

Similar companies