Stratec Biomedical Uk L T D

FDA Filings

This page includes the latest FDA filings for Stratec Biomedical Uk 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: 3003966680
• FEI Number: 3003966680
• Name: STRATEC Biomedical UK Limited
• Owner & Operator: STRATEC Biomedical UK Limited
• Contact Address: Centrum Point, Third Avenue Centrum 100; BURTON-ON-TENT GB-STS Staffordshire DE14 2WD GB
• US Agent:
  • Eric H. Waltz
  • STRATEC BIOMEDICAL Inc
  • 805 4098508
  • 860 4261855
  • e.waltz@stratec.com
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: Third Avenue Centrum 100; BURTON-ON-TRENT Staffordshire, DE14 2WD GB
• Establishment Type: Manufacture Medical Device

FDA Filings

Device Company	Device	Date
PMN BK190434 STRATEC Biomedical UK Limited	Automated Blood Grouping And Antibody Test Systems	2020-03-10
GUDID 05060496770059 STRATEC BIOMEDICAL UK LIMITED	Sanguin Liberty SRIMPORT	2018-11-29
GUDID 05060496770035 STRATEC BIOMEDICAL UK LIMITED	Sanguin Aurora	2018-11-23
PMN BK160071 | MMH STRATEC Biomedical UK Limited	Aurora Enterprise	2018-11-21
GUDID 05060496770028 STRATEC BIOMEDICAL UK LIMITED	ORTHO CONNECT	2018-11-02
GUDID 05060496770011 STRATEC BIOMEDICAL UK LIMITED	Procleix NAT Manager	2018-11-02
GUDID 05060496770004 STRATEC BIOMEDICAL UK LIMITED	cobas Synergy	2018-10-19
PMN BK160125 | PQQ STRATEC Biomedical UK Limited	Procleix NAT Manager v1.2 Software	2018-09-19
PMN BK160124 | KSZ STRATEC Biomedical UK Limited	ORTHO CONNECT	2018-09-19
PMN BK160113 | PQQ STRATEC Biomedical UK Limited	cobas Synergy Software	2018-09-19
PMN BK160071 STRATEC Biomedical UK Limited	510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Food Drugs Medical Devices	2017-10-30
PMN BK160124 STRATEC Biomedical UK Limited	Automated Blood Grouping And Antibody Test Systems	2017-10-17
PMN BK160125 STRATEC Biomedical UK Limited	510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Food Drugs Medical Devices	2017-04-25
PMN BK160113 STRATEC Biomedical UK Limited	510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Food Drugs Medical Devices	2017-04-19
PMN BK130052 | MMH STRATEC Biomedical UK Limited	Procleix NAT Manager Software (Version 1.1)	2016-05-06
PMN BK130052 STRATEC Biomedical UK Limited	510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Food Drugs Medical Devices	2014-04-17
PMN BK100030 | MMH STRATEC Biomedical UK Limited	Sanguin Liberty SR Import v3.1	2012-12-17
PMN BK090061 | MMH STRATEC Biomedical UK Limited	Sanguin Aurora v2.0	2012-12-17
PMN BK090061 | MMH STRATEC Biomedical UK Limited	STRATEC Aurora	2012-12-17
PMN BK090061 | MMH STRATEC Biomedical UK Limited	STRATEC Aurora TOUCH	2012-12-17