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Philips Healthcare Group

USA · San Diego

✓ Record-verifiedregistrations found in 4 markets

This company has registrations in United States, Brazil, Saudi Arabia, Canada — 4 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

25listed device types

Class I 13Class II 12Class III 0

plus 42 registration records and 49 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

6registered devices

Class II 6

10 including historic records

SASaudi ArabiaSFDA

40registered imported devices

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

CACanadaMDALL

4active device licences

Class II 4

21 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 States42 registration records, 49 510(k), 0 PMA, 95 excluded

Brazil6 confirmed, 18 excluded

Saudi Arabia40 confirmed, 11 excluded

Canada4 confirmed, 25 excluded

Manufacturer names merged into this page: PHILIPS ORAL HEALTHCARE, LLC · Philips (China) Investment Co., Ltd. Philips Healthcare - Shanghai CDC · Philips Healthcare (Suzhou) Co., Ltd. · PHILIPS HEALTHCARE INFORMATICS, INC. · PHILIPS HEALTHCARE · PHILIPS HEALTHCARE, A DIVISION OF PHILIPS ELECTRONICS LTD.

FDA 510(k) clearances by year

12004

32011

72012

52013

22014

22015

32016

32017

32018

42019

52020

32021

22022

12023

32024

22026

FDA listed device types

showing 8 of 25

Absorber, Saliva, Paper 1Toothbrush, Powered 1Oral Irrigation Kit 1Unit, Ultraviolet Sanitation/Sterilization (For Toothbrushes), Non-Sterile 1Accessories, Retractor, Dental 1Cotton, Roll 1Dam, Rubber 1Shield, Eye, Radiological 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K252992	CT Rembra RT; CT Areta RT; CT Rembra	2026-03-23
US	K260519	Smart Fit TorsoCardiac 1.5T	2026-03-20
US	K242329	CT Collaboration Live	2024-11-18
BR	10216710255	RASTREADORES	Class II
BR	10216710256	INTRODUTORES DE POLO-ÚNICO RFA	Class II
BR	10216710252	Introdutores de Biópsia	Class II
SA	ME0000000923SFDAA00028	Philips Sonicare toothbruch 1100 series	—
SA	ME0000000926SFDAA00023	Philips Sonicare C1 ProResults	—
CA	74888	REPLACEMENT BRUSH HEADS FOR SONICARE TOOTHBRUSH	Class II
CA	86712	AIRFLOSS	Class II
CA	62673	PACS	Class II

Philips Healthcare Group

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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