Qbtech Ab

FDA Filings

This page includes the latest FDA filings for Qbtech Ab. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

• Registration Number: 3004529412
• FEI Number: 3004529412
• Name: Rene Van De Zande
• Owner & Operator: QBTECH AB
• Contact Address: KUNGSGATAN 29 --; STOCKHOLM SE-NOTA 11156 SE
• US Agent:
  • Rene Van De Zande
  • Emergo Global Representation LLC
  • 512 3279997
  • 512 3279998
  • USAgent@ul.com
• Importing Logistics Registration:
  • Importer: Qbtech Inc
  • Address: c/o The Corporation Trust Company 1209 Orange Street ; Wilmington, DE 19801 UNITED STATES
  • Email Address: gunnar.haawind@qbtech.se
  • Phone: 1 650 3506000
  • Importer Type: Retailer
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 2500 Bee Cave Road Bldg 1, Suite 300; Austin, TX 78746 US
• Establishment Type: Manufacture Medical Device

FDA Filings

Device Company	Device	Date
GUDID 07350103930067 Qbtech AB	QbTest	2023-06-22
GUDID 07350103930012 Qbtech AB	QbCheck	2023-06-22
PMN K143468 QBTECH AB	QbCheck	2016-03-22
PMN K133382 | LQD Rene Van De Zande [QBTECH AB]	QbTest	2014-12-30
PMN K133382 QBTECH AB	QB TEST	2014-03-24
PMN K122149 | LQD Rene Van De Zande [QBTECH AB]	QbTest	2012-12-21
PMN K122149 QBTECH AB	QBTES	2012-10-17
PMN K040894 | LQD Rene Van De Zande [QBTECH AB]	QbTest	2007-11-23
PMN K040894 QBTECH AB	QBTEST	2004-06-22