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North American Philips Corp.

USA · Mchenry

✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Brazil, Canada — 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

82listed device types

Class I 12Class II 68Class III 2

plus 242 registration records and 113 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

1registered devices

Class II 1

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

60active device licences

Class II 49Class III 11

257 including historic records

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

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 States242 registration records, 113 510(k), 0 PMA, 98 excluded

Brazil1 confirmed, 20 excluded

Saudi Arabia0 confirmed, 14 excluded

Canada60 confirmed, 27 excluded

Manufacturer names merged into this page: Philips North America LLC · Philips DS North America LLC · RESPIRONICS INC. ALSO TRADING AS PHILIPS RS NORTH AMERICA LLC · PHILIPS DS NORTH AMERICA LLC · PHILIPS NORTH AMERICA, LLC

FDA 510(k) clearances by year

31993

61994

51995

21996

61997

91998

71999

82000

32001

42002

62003

62004

32005

72006

12007

12008

22009

22010

12021

12025

FDA listed device types

showing 8 of 82

Generator, Electroencephalograph Test Signal 1Medical Device Data System 1Infant Heel Warmer (Chemical Heat Pack) 1Bilirubin (Total And Unbound) In The Neonate Test System 1Mask, Oxygen, Non-Rebreathing 1System, Signal Isolation 1Tape And Bandage, Adhesive 1Cannula, Nasal, Oxygen 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K250800	UroNav 4	2025-06-05
US	K203231	Switched Internal Paddles	2021-01-11
US	K101311	EP NAVIGATOR R3	2010-09-30
BR	10216710266	DYNACAD	Class II
CA	12771	NU-MO GARMENTS	Class III
CA	12775	CHEST SHELLS	Class III
CA	13087	BIPAP SYSTEMS AND REMOTE CONTROL UNIT	Class III

North American Philips Corp.

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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