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Philips North America, LLC

USA · Cambridge
✓ Record-verifiedregistrations found in 7 markets

This company has registrations in United States, Brazil, Canada, Taiwan, Singapore, South Korea, 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
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
8valid device licences
Class II 8
SGSingaporeHSA SMDR
1device registrations
CLASS C 1
KRSouth KoreaMFDS GMP
4GMP quality-system certificates
Import 4
AUAustraliaTGA ARTG
pendingnot queried
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
1registrations
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
Same-named companies — This database also contains companies with near-identical names: North American Philips Corp.. Company name alone cannot separate their registrations, so the figures below may include either.

Company information

Country
USA
City
Cambridge

Fields marked "pending" have not been obtained yet; that does not mean they do not exist. Risk records (litigation, penalties, operating anomalies) are kept internal and not published.

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)

MarketIdentifierNameClass / date
USK250800UroNav 42025-06-05
USK203231Switched Internal Paddles2021-01-11
USK101311EP NAVIGATOR R32010-09-30
BR10216710266DYNACADClass II
CA12771NU-MO GARMENTSClass III
CA12775CHEST SHELLSClass III
CA13087BIPAP SYSTEMS AND REMOTE CONTROL UNITClass III

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