Stratec Se

FDA Filings

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

GERMANY

XETRA

SBS

DUNS 340361455

FDA Registration(s)

• Registration Number: 8043379
• FEI Number: 3003413192
• Name: STRATEC SE
• Owner & Operator: STRATEC BIOMEDICAL AG
• Contact Address: GEWERBESTRASSE 37 --; BIRKENFELD, GRAEFENHAUSEN, BW DE-BW Baden-Wurttemberg 75217 DE
• Official Correspondent:
  • VOLKER - SCHWAAB
  • 49-7082-7916-189
• US Agent:
  • Connie Higgs
  • STRATEC Biomedical USA Inc
  • 805 4098508
  • 805 4261855
  • c.higgs@stratec.com
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: GEWERBESTRASSE 37 ; BIRKENFELD, GRAEFENHAUSEN Baden-Wurttemb, 75217 DE
• Establishment Type:
  • Manufacture Medical Device
  • Manufacture Medical Device for Another Party (Contract Manufacturer)

FDA Filings

Device Company	Device	Date
GUDID 04260678680010 STRATEC SE	GEMINI 10041566	2025-09-15
JJH STRATEC SE [STRATEC BIOMEDICAL AG]	InviGenius?	2014-09-18
JJH STRATEC SE [STRATEC BIOMEDICAL AG]	InviGenius? PLUS	2014-09-18
JJE STRATEC SE [STRATEC BIOMEDICAL AG]	GEMINI Compact Microplate Processor	2008-06-10
JJE STRATEC SE [STRATEC BIOMEDICAL AG]	GEMINI Combo	2008-06-10