Bioview L T D

FDA Filings

This page includes the latest FDA filings for Bioview L T D. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

Registration Number	3003834059
FEI Number	3003834059
Name	BIOVIEW
Owner & Operator	BIOVIEW LTD.
Contact Address	3 Pekeris Street -- Rehovot IL-NOTA 7670203 IL
Official Correspondent	YUVAL - HARARI 972-893-66868-x
Registration Status	1
Initial Importer	Y
Registration Expiration	2020-04-25
Registration Address	44 MANNING RD STE 4 Billerica, MA 01821 US

Registration Number

3003909093

FEI Number

3003909093

Name

David Kutas

Owner & Operator

BIOVIEW LTD.

Contact Address

3 Pekeris Street --
Rehovot IL-NOTA 7670203 IL

Official Correspondent

YUVAL - HARARI
972-893-66868-x

US Agent

David Kutas
BIOVIEW USA INC.
978 6704741
978 6704740
david@BIOVIEW.CO.IL

Importing Logistics Registration

Importer	BioView Inc.
Address	44 Manning Road Billerica, MA 01821 UNITED STATES
Importer Type	Agent

Registration Status

Initial Importer

Registration Expiration

2020-04-25

Registration Address

44 MANNING RD.
BILLERICA, MA 01821 US

Establishment Type

Manufacture Medical Device

FDA Filings

Device Company	Device	Date
PMN K130775 \| NTH David Kutas [BIOVIEW LTD.]	SoloWeb analysis configuration	2015-04-21
PMN K130775 \| NTH David Kutas [BIOVIEW LTD.]	Solo? Review workstation	2015-04-21
PMN K130775 \| NTH David Kutas [BIOVIEW LTD.]	Solo-Touch Review workstation	2015-04-21
PMN K130775 \| NTH David Kutas [BIOVIEW LTD.]	SIMP ? (?Slide Interface Messaging Protocol?)	2015-04-21
PMN K130775 \| NTH David Kutas [BIOVIEW LTD.]	Encore	2015-04-21
PMN K130775 \| NTH David Kutas [BIOVIEW LTD.]	Duet-3	2015-04-21
PMN K130775 \| NTH David Kutas [BIOVIEW LTD.]	Allegro Plus	2015-04-21
PMN K130775 \| NTH David Kutas [BIOVIEW LTD.]	Accord Plus	2015-04-21
PMN K130775 \| JOY David Kutas [BIOVIEW LTD.]	SoloWeb analysis configuration	2015-04-21
PMN K130775 \| JOY David Kutas [BIOVIEW LTD.]	Solo? Review workstation	2015-04-21
PMN K130775 \| JOY David Kutas [BIOVIEW LTD.]	Solo-Touch Review workstation	2015-04-21
PMN K130775 \| JOY David Kutas [BIOVIEW LTD.]	SIMP ? (?Slide Interface Messaging Protocol?)	2015-04-21
PMN K130775 \| JOY David Kutas [BIOVIEW LTD.]	Encore	2015-04-21
PMN K130775 \| JOY David Kutas [BIOVIEW LTD.]	Duet-3	2015-04-21
PMN K130775 \| JOY David Kutas [BIOVIEW LTD.]	Allegro Plus	2015-04-21
PMN K130775 \| JOY David Kutas [BIOVIEW LTD.]	Accord Plus	2015-04-21
PMN K130775 BIOVIEW LTD.	DUET SYSTEM	2014-05-09
PMN K061602 BIOVIEW LTD.	DUET SYSTEM	2007-01-23
PMN K050840 BIOVIEW LTD.	MODIFICATION TO DUET SYSTEM	2005-08-16
PMN K040591 BIOVIEW LTD.	DUET SYSTEM	2004-09-16
PMN K030192 BIOVIEW LTD.	DUET SYSTEM	2003-08-20
PPM David Kutas [BIOVIEW LTD.]	BIOWHITE	2003-05-05
PPM David Kutas [BIOVIEW LTD.]	BIOWHITE-SUPPLEMENT	2003-05-05
PPM David Kutas [BIOVIEW LTD.]	BIOWHITE-AMNIO	2003-05-05
PPM David Kutas [BIOVIEW LTD.]	BIOBLUE	2003-05-05
PPM David Kutas [BIOVIEW LTD.]	BIOBLUE DROP	2003-05-05
PPM David Kutas [BIOVIEW LTD.]	BIOBLUE AMNIO	2003-05-05

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