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INVIVO CORPORATION

USA · Gainesville

✓ Record-verifiedregistrations found in 10 markets

This company has registrations in United States, Brazil, Saudi Arabia, Canada, Taiwan, Singapore, 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

n/aThis registry lists domestic registrants only

EUEuropean UnionEUDAMED

pendingnot queried

USUnited StatesFDA openFDA

3listed device types

Class I 1Class II 2Class III 0

plus 6 registration records and 39 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

2registered devices

Class II 2

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

SASaudi ArabiaSFDA

2registered imported devices

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

CACanadaMDALL

21active device licences

Class II 21

25 including historic records

TWTaiwanTFDA

1valid device licences

Class II 1

SGSingaporeHSA SMDR

6device registrations

CLASS B 3CLASS C 3

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

14active ARTG entries

Class I 5IIa 6IIb 1Class Is (sterile) 2

HKHong KongMDACS

1valid listings

Class III 1

ILIsraelAMAR

6registrations

RURussiaRoszdravnadzor

1active registrations

Class 2b 1

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 States6 registration records, 39 510(k), 0 PMA, 5 excluded

Brazil2 confirmed, 2 excluded

Saudi Arabia2 confirmed, 2 excluded

Canada21 confirmed, 2 excluded

Manufacturer names merged into this page: INVIVO CORPORATION · Invivo Corporation

FDA 510(k) clearances by year

42005

52006

22007

32008

22009

22010

32011

42012

32013

12014

22015

22016

12018

22019

32021

FDA listed device types

Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) 1Electrode, Electrocardiograph 1Recorder, Paper Chart 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K213766	dS FootAnkle 16Ch Coils for 1.5T and 3.0T, dS HiRes HandWrist 16Ch Coils for 1.5T and 3.0T, ds Small Extremity 16Ch Coils for 1.5T and 3.0T	2021-12-23
US	K212227	Philips MR Patient Care Portal	2021-09-30
US	K212175	DynaCAD	2021-08-02
BR	10216710283	DYNASUITE NEURO	Class II
BR	10216710234	DYNATRIM	Class II
SA	ME0000003238SFDAA00088	SensaVue fMRI	—
SA	ME0000003238SFDAA00087	SensaVue HD	—
CA	63618	455 PHASED ARRAY WRIST COILS	Class II
CA	63630	QUADRATURE LOWER EXTREMITY COILS	Class II
CA	63893	QUADRATURE WRIST COILS	Class II

INVIVO CORPORATION

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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