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Invivo Research Labs, Inc.

USA · Mchenry

✓ Record-verifiedregistrations found in 2 markets

This company has registrations in United States, Brazil — 2 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

19510(k) clearances

Class I 0Class II 0Class III 0

plus 0 registration records and 19 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

2registered devices

Class I 1Class 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

0active device licences

TWTaiwanTFDA

0valid device licences

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

pendingnot queried

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, 19 510(k), 0 PMA, 7 excluded

Brazil2 confirmed, 2 excluded

Saudi Arabia0 confirmed, 3 excluded

Canada0 confirmed, 3 excluded

Manufacturer names merged into this page: INVIVO RESEARCH, INC.

Registration details (sample)

Market	Identifier	Name	Class / date
US	K050399	MRI COMPATIBLE PATIENT MONITORING SYSTEM, MODEL 3160	2005-08-26
US	K043354	MODULAR TELEMETRY SYSTEM FOR THE VISION TELEPAK, MODEL 20701	2005-01-10
US	K041918	INTEGRATED PATIENT MONITORING SYSTEM	2004-10-15
BR	80175170006	Brocas Diamantadas Polidoras	Class II
BR	10355879006	ELETRODOS QUADTRODE PARA RM	Class I

Invivo Research Labs, Inc.

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

Registration details (sample)

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