Volpara Health Technologies L T D FDA Filings

FDA Registration(s)

Registration Number

3009117933

FEI Number

3009117933

Name

Sheila Pickering

Owner & Operator

Volpara Health Technologies Limited

Contact Address

Level 14, Simpl House 40 Mercer Street
Wellington Central NZ-WGN Wellington 6011 NZ

Official Correspondent

Ralph P Highnam
064-4-4996029-x

US Agent

Sheila Pickering
650 2790668
sheilawalshpickering@gmail.com

Importing Logistics Registration

Importer	Alpha Imaging
Address	4455 Glenbrook Rd Willoughby, OH 44094 UNITED STATES

Importing Logistics Registration

Importer	Mammography Reporting System Inc.
Address	9709 3rd Ave NE - Suite 208 Seattle, WA 98115 UNITED STATES

Importing Logistics Registration

Importer	Physicians Consultant Medical Sales, Inc.
Address	50 Liberty Avenue Lindenhurst, NY 11757 UNITED STATES

Importing Logistics Registration

Importer	Triangle X-ray Co.
Address	4900 Thornton Road, Suite 117 Raleigh, NC 27616 UNITED STATES

Registration Status

Initial Importer

Registration Expiration

2020-04-25

Registration Address

2081 Longden Cir
Los Altos, CA 94024 US

Establishment Type

Manufacture Medical Device
Complaint File Establishment per 21 CFR 820.198

FDA Filings

Device Company	Device	Date
PMN K211279 Volpara Health Technologies Limited	Volpara Imaging Software	2021-07-27
GUDID 09421904268241 VOLPARA HEALTH TECHNOLOGIES LIMITED	VolparaDensity	2020-10-09
GUDID 09421904268319 VOLPARA HEALTH TECHNOLOGIES LIMITED	Volpara Density Map	2020-10-02
GUDID 09421904268302 VOLPARA HEALTH TECHNOLOGIES LIMITED	VolparaDoseSR	2020-10-02
GUDID 09421904268296 VOLPARA HEALTH TECHNOLOGIES LIMITED	VolparaDoseRT	2020-10-02
GUDID 09421904268289 VOLPARA HEALTH TECHNOLOGIES LIMITED	Volpara Density Map	2020-10-02
GUDID 09421904268272 VOLPARA HEALTH TECHNOLOGIES LIMITED	VolparaDoseSR	2020-10-02
GUDID 09421904268265 VOLPARA HEALTH TECHNOLOGIES LIMITED	VolparaDoseRT	2020-10-02
GUDID 09421904268258 VOLPARA HEALTH TECHNOLOGIES LIMITED	VolparaDensity	2020-09-03
GUDID 09421904268166 VOLPARA HEALTH TECHNOLOGIES LIMITED	VolparaDensity	2019-10-07
GUDID 09421904268128 VOLPARA HEALTH TECHNOLOGIES LIMITED	Volpara Density Map	2019-10-07
GUDID 09421904268104 VOLPARA HEALTH TECHNOLOGIES LIMITED	VolparaDoseRT	2019-10-07
GUDID 09421904268098 VOLPARA HEALTH TECHNOLOGIES LIMITED	VolparaDensity	2019-10-07
GUDID 09421904268074 VOLPARA HEALTH TECHNOLOGIES LIMITED	VolparaServer	2019-10-07
GUDID 09421904268050 VOLPARA HEALTH TECHNOLOGIES LIMITED	Volpara Density Map	2019-10-07
GUDID 09421904268043 VOLPARA HEALTH TECHNOLOGIES LIMITED	VolparaDoseSR	2019-10-07
GUDID 09421904268036 VOLPARA HEALTH TECHNOLOGIES LIMITED	VolparaDoseRT	2019-10-07
GUDID 09421904268029 VOLPARA HEALTH TECHNOLOGIES LIMITED	VolparaDensity	2019-10-07
PMN K182310 Volpara Health Technologies Limited	Volpara Imaging Software	2018-09-21
PMN K153427 \| LLZ Sheila Pickering [Volpara Health Technologies Limited]	VolparaDensityMap	2016-03-13
PMN K153427 \| LLZ Sheila Pickering [Volpara Health Technologies Limited]	VolparaDensity	2016-03-13
PMN K152028 \| LLZ Sheila Pickering [Volpara Health Technologies Limited]	VolpareDensity	2015-11-17
LHO Sheila Pickering [Volpara Health Technologies Limited]	VolparaPressure	2013-12-03
LHO Sheila Pickering [Volpara Health Technologies Limited]	VolparaPosition	2013-12-03
LHO Sheila Pickering [Volpara Health Technologies Limited]	VolparaLive!	2013-12-03
LHO Sheila Pickering [Volpara Health Technologies Limited]	VolparaDoseRT (includes VolparaPressure & VolparaPosition)	2013-12-03
LHO Sheila Pickering [Volpara Health Technologies Limited]	VolparaDose	2013-12-03
PMN K102556 \| LLZ Sheila Pickering [Volpara Health Technologies Limited]	VolparaDensity	2010-11-23
PMN K102556 \| LLZ Sheila Pickering [Volpara Health Technologies Limited]	Volpara	2010-11-23