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VENTANA MEDICAL SYSTEMS, INC.

USA · Tucson

✓ Record-verifiedregistrations found in 10 markets

This company has registrations in United States, Brazil, Canada, Taiwan, Singapore, South Korea, 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

55listed device types

Class I 33Class II 9Class III 11unclassified 2

plus 69 registration records and 50 510(k), 269 PMA

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

29registered devices

Class I 26Class II 3

53 including historic records

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

122active device licences

Class II 122

316 including historic records

TWTaiwanTFDA

67valid device licences

Class I 37Class II 18Class III 12

SGSingaporeHSA SMDR

38device registrations

CLASS B 30CLASS C 8

KRSouth KoreaMFDS GMP

3GMP quality-system certificates

IVD import 3

AUAustraliaTGA ARTG

16active ARTG entries

IVD Class 1 2IVD Class 2 5IVD Class 3 9

HKHong KongMDACS

91valid listings

IVD B 18IVD C 73

ILIsraelAMAR

43registrations

RURussiaRoszdravnadzor

30active registrations

Class 2a 6Class 2b 24

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 States69 registration records, 50 510(k), 269 PMA, 1 excluded

Brazil29 confirmed, 0 excluded

Canada122 confirmed, 0 excluded

Manufacturer names merged into this page: VENTANA MEDICAL SYSTEMS, INC. · VENTANA MEDICAL SYSTEMS INC · VENTANA MEDICAL SYSTEM, INC · VENTANA MEDICAL SYSTEMS, INC · VENTANA MEDICAL SYSTEMS

Same-named companies — This database also contains companies with near-identical names: VENTANA MEDICAL INC, VENTANA MEDICAL SYSTEM, INC, Ventana Medical Systems, Inc. (Roche Tissue Diagnostics). Company name alone cannot separate their registrations, so the figures below may include either.

FDA 510(k) clearances by year

21992

41993

21994

11995

61996

131997

11999

32011

52012

42013

12014

12015

22017

12018

12021

32024

FDA listed device types

showing 8 of 55

Immunohistochemistry Assay, Antibody, Programmed Death-Ligand 1 1Immunocytochemistry Assay, P16/Ki-67 1Kit, Dna Detection, Human Papillomavirus 1System, Test, Her-2/Neu, Ihc 1Immunohistochemistry Assay, Antibody, Folr1 1Immunohistochemistry Assay, Antibody, Claudin 18 1Immunohistochemistry Assay, Antibody, Anaplastic Lymphoma Kinase 1Immunohistochemistry Assay, Antibody, Met 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K242783	Roche Digital Pathology Dx	2024-12-17
US	DEN240025	VENTANA Kappa and Lambda Dual ISH mRNA Probe Cocktail (08507023001)	2024-12-05
US	K232879	Roche Digital Pathology Dx (VENTANA DP 200)	2024-06-14
BR	10287410845	BENCHMARK	Class I
BR	10287411794	Família de Corantes Stain Core	Class I
BR	10287411753	Rabbit Monoclonal Negative Control Ig	Class II
CA	4401	ANTI-CEA (TF 3H8-1) PRIMARY ANTIBODY	Class II
CA	4402	ANTI-ACTIN, MUSCLE (HUC 1-1) PRIMARY ANTIBODY	Class II
CA	4405	CONFIRM ANTI-VIMENTIN (VIM3B4) PRIMARY ANTIBODY	Class II