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Philips Healthcare (Suzhou) Co., Ltd.

China · Suzhou

✓ Record-verifiedregistrations found in 10 markets

This company has registrations in United States, Brazil, Canada, Taiwan, Singapore, South Korea, Australia, Hong Kong, Israel, Russia — 10 overseas markets. The China NMPA lookup is still pending.

Registrations by market

Each market counts a different unit; figures are not directly comparable

CNChinaNMPA

pendingnot queried

EUEuropean UnionEUDAMED

pendingnot queried

USUnited StatesFDA openFDA

5listed device types

Class I 0Class II 5Class III 0

plus 18 registration records and 20 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

2registered devices

Class II 2

6 including historic records

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

1active device licences

Class II 1

10 including historic records

TWTaiwanTFDA

7valid device licences

Class II 7

SGSingaporeHSA SMDR

11device registrations

CLASS B 3CLASS C 8

KRSouth KoreaMFDS GMP

4GMP quality-system certificates

Import 4

AUAustraliaTGA ARTG

3active ARTG entries

IIa 1IIb 2

HKHong KongMDACS

5valid listings

Class III 5

ILIsraelAMAR

4registrations

RURussiaRoszdravnadzor

11active registrations

Class 2a 2Class 2b 9

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 States18 registration records, 20 510(k), 0 PMA, 101 excluded

Brazil2 confirmed, 19 excluded

Saudi Arabia0 confirmed, 14 excluded

Canada1 confirmed, 28 excluded

Manufacturer names merged into this page: Philips Healthcare (Suzhou) Co., Ltd. · PHILIPS HEALTHCARE · PHILIPS HEALTHCARE (SUZHOU) CO., LTD. · PHILIPS HEALTHCARE (SUZHOU) CO., LTD

FDA 510(k) clearances by year

12012

12014

12015

12017

22018

12019

22020

32021

22022

12023

32024

22026

FDA listed device types

Coil, Magnetic Resonance, Specialty 1System, Planning, Radiation Therapy Treatment 1Solid State X-Ray Imager (Flat Panel/Digital Imager) 1System, X-Ray, Tomography, Computed 1System, X-Ray, Stationary 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	10216710293	EQUIPAMENTO DE RESSONANCIA MAGNETICA	Class II
BR	10216710351	Prodiva 1.5T	Class II
CA	93854	DURADIAGNOST COMPACT	Class II

Philips Healthcare (Suzhou) Co., Ltd.

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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