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Bioview , Ltd.

Israel · Rehovot

✓ Record-verifiedregistrations found in 6 markets

This company has registrations in United States, Brazil, Canada, South Korea, Australia, Israel — 6 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 2 registration records and 5 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

1registered devices

Class 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

1 including historic records

TWTaiwanTFDA

0valid device licences

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

1GMP quality-system certificates

Import 1

AUAustraliaTGA ARTG

2active ARTG entries

IVD Class 1 1IVD Class 3 1

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

1registrations

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 States2 registration records, 5 510(k), 0 PMA

Brazil1 confirmed, 0 excluded

Manufacturer names merged into this page: BIOVIEW LTD.

FDA 510(k) clearances by year

12003 · K030192

12004 · K040591

12005 · K050840

12007 · K061602

12014 · K130775

FDA listed device types

System, Automated Scanning Microscope And Image Analysis For Fluorescence In Situ Hybridization (Fish) Assays 1Device, Automated Cell-Locating 1General Purpose Reagent 1

Market	Identifier	Name	Class / date
US	K130775	DUET SYSTEM	2014-05-09
US	K061602	DUET SYSTEM	2007-01-23
US	K050840	MODIFICATION TO DUET SYSTEM	2005-08-16
BR	80810330002	Família Duet	Class II

Bioview , Ltd.

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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