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Tripath Imaging, Inc.

USA · Redmond

✓ Record-verifiedregistrations found in 5 markets

This company has registrations in United States, Brazil, Canada, Israel, Russia — 5 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

5510(k) clearances

Class I 0Class II 0Class III 0

plus 0 registration records and 5 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

2registered devices

Class I 2

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

5active device licences

Class II 4Class III 1

6 including historic records

TWTaiwanTFDA

0valid device licences

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

1registrations

RURussiaRoszdravnadzor

2active registrations

Class 2a 2

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, 5 510(k), 0 PMA

Brazil2 confirmed, 1 excluded

Canada5 confirmed, 0 excluded

Manufacturer names merged into this page: TRIPATH IMAGING INC. · TRIPATH IMAGING, INC. · TRIPATH IMAGING, INC

Registration details (sample)

Market	Identifier	Name	Class / date
US	K061613	VENTANA IMAGE ANALYSIS SYSTEM - PATHWAY HER2 (4B5)	2007-01-10
US	K062428	VENTANA IMAGE ANALYSIS SYSTEM, MODEL VIAS	2006-09-29
US	K053520	VENTANA IMAGE ANALYSIS SYSTEM, MODEL KI-67	2006-04-11
BR	10033439070	BD TOTALYS SLIDEPREP	Class I
BR	10033430551	PREPSTAIN SLIDE PROCESSOR	Class I
CA	317	AUTOPAP 300 QC AUTOMATIC PAP SCREENER SYSTEM	Class III
CA	69542	VENTANA IMAGE ANALYSIS SYSTEM (VIAS)	Class II
CA	71159	SUREDETECT SIHA CELL CONTROL	Class II

Tripath Imaging, Inc.

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

Registration details (sample)

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