Home›USA›Philips DS North America, LLC

Philips DS North America, LLC

USA · Gainsville

✓ Record-verifiedregistrations found in 7 markets

This company has registrations in United States, Brazil, Canada, Taiwan, Singapore, Australia, Israel — 7 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

4listed device types

Class I 1Class II 3Class III 0

plus 10 registration records and 1 510(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

2active device licences

Class II 2

6 including historic records

TWTaiwanTFDA

1valid device licences

Class II 1

SGSingaporeHSA SMDR

2device registrations

CLASS B 2

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

1active ARTG entries

IIa 1

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

2registrations

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 States10 registration records, 1 510(k), 0 PMA, 8 excluded

Brazil1 confirmed, 1 excluded

Saudi Arabia0 confirmed, 2 excluded

Canada2 confirmed, 2 excluded

Manufacturer names merged into this page: Philips DS North America LLC · PHILIPS DS NORTH AMERICA LLC

FDA 510(k) clearances by year

12025 · K250800

FDA listed device types

System, Nuclear Magnetic Resonance Imaging 1System, Image Processing, Radiological 1Radiological Image Processing Software For Ablation Therapy Planning And Evaluation 1Guide, Needle, Surgical 1

Market	Identifier	Name	Class / date
US	K250800	UroNav 4	2025-06-05
BR	10216710266	DYNACAD	Class II
CA	83325	BIOPSY GUNS	Class II
CA	106696	CLARIFEYE NEEDLE	Class II

Philips DS North America, LLC

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

Similar companies