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Philips Oral Healthcare, Inc.

USA · Bothell

✓ Record-verifiedregistrations found in 4 markets

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

14listed device types

Class I 13Class II 1Class III 0

plus 14 registration records and 1 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

0registered devices

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

SASaudi ArabiaSFDA

40registered imported devices

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

CACanadaMDALL

2active device licences

Class II 2

9 including historic records

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

1active ARTG entries

Class I 1

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 States14 registration records, 1 510(k), 0 PMA, 42 excluded

Brazil0 confirmed, 3 excluded

Saudi Arabia40 confirmed, 3 excluded

Canada2 confirmed, 6 excluded

Manufacturer names merged into this page: PHILIPS ORAL HEALTHCARE, LLC · Philips Oral Healthcare, LLC · Philips Oral Healthcare LLC · philips oral healthcare

FDA 510(k) clearances by year

12004 · K040416

FDA listed device types

showing 8 of 14

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	K040416	SONICARE ADVANCE TOOTHBRUSH, MODEL 4900	2004-07-02
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

Philips Oral Healthcare, 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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