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INVIVO, A DIVISION OF PHILIPS MEDICAL SYSTEMS

USA · Orlando

✓ Record-verifiedregistrations found in 7 markets

This company has registrations in United States, Saudi Arabia, Canada, Singapore, Australia, Hong Kong, 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

6510(k) clearances

Class I 0Class II 0Class III 0

plus 0 registration records and 6 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

0registered devices

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

SASaudi ArabiaSFDA

24registered imported devices

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

CACanadaMDALL

22active device licences

Class II 10Class III 12

45 including historic records

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

3device registrations

CLASS C 3

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

30active ARTG entries

Class I 20IIa 5IIb 5

HKHong KongMDACS

1valid listings

Class III 1

ILIsraelAMAR

3registrations

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 States0 registration records, 6 510(k), 0 PMA, 8 excluded

Brazil0 confirmed, 3 excluded

Saudi Arabia24 confirmed, 1 excluded

Canada22 confirmed, 1 excluded

Manufacturer names merged into this page: INVIVO, A DIVISION OF PHILIPS MEDICAL SYSTEMS · INVIVO GERMANY, A DIV. OF PHILIPS MEDICAL SYSTEMS DMC GMBH · Invivo, a division of Philips Medical Systems · INVIVO, a division of Philips Medical Systems

Registration details (sample)

Market	Identifier	Name	Class / date
US	K232762	dS Breast Coil 7ch 1.5T	2023-10-03
US	K222325	8ch Wrist Coil	2022-08-31
US	K222257	1.5 T/R Quad Extremity Coil, 1.5T 8CH T/R Knee Coil	2022-08-23
SA	ME0000009230SFDAA00001	Kit, Water Trap, EtCO2, 3160	—
SA	ME0000003239SFDAA00013	NBP Cuff	—
CA	6062	EPOCHSAT PC SOFTWARE	Class III
CA	33369	SERIES IV/III PHYSIOMONITORING SYSTEM	Class III
CA	61952	CENTURION CENTRAL STATION	Class III

INVIVO, A DIVISION OF PHILIPS MEDICAL SYSTEMS

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

Registration details (sample)

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