Stratec Biomedical Ag

FDA Filings

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

FDA Registration(s)
Registration Number8043379
FEI Number3003413192
NameSTRATEC SE
Owner & OperatorSTRATEC BIOMEDICAL AG
Contact AddressGEWERBESTRASSE 37 --
BIRKENFELD, GRAEFENHAUSEN, BW DE-BW Baden-Wurttemberg 75217 DE
Official Correspondent
  • VOLKER - SCHWAAB
  • 49-7082-7916-189
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration AddressGEWERBESTRASSE 37
BIRKENFELD, GRAEFENHAUSEN Baden-Wurttemb, 75217 DE
Establishment Type
  • Manufacture Medical Device
  • Manufacture Medical Device for Another Party (Contract Manufacturer)

FDA Owner/Operator Registration

FDA Filings

Device
Company
DeviceDate
STRATEC SE [STRATEC BIOMEDICAL AG]
InviGenius?2014-09-18
STRATEC SE [STRATEC BIOMEDICAL AG]
InviGenius? PLUS2014-09-18
STRATEC SE [STRATEC BIOMEDICAL AG]
GEMINI Compact Microplate Processor2008-06-10
STRATEC SE [STRATEC BIOMEDICAL AG]
GEMINI Combo2008-06-10

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Related Finance Registrations
U.S. Import Records [external site]
Import IDShipmentCargo DescriptionQuantity
2020082459148Bremerhaven,Federal Republic of Germany -> Savannah, GeorgiaLABORATORY EQUIPMENTHS CODE 9027801720 PKG
2020071532931Bremerhaven,Federal Republic of Germany -> Savannah, GeorgiaLABORATORY EQUIPMENTHS CODE 9027801720 PKG
2020052019834Bremerhaven,Federal Republic of Germany -> Savannah, GeorgiaLABORATORY EQUIPMENTHS CODE 9027801740 PKG
2020051920707Bremerhaven,Federal Republic of Germany -> Savannah, GeorgiaLABORATORY EQUIPMENTHS CODE 9027801740 PKG
2020033134645Bremerhaven,Federal Republic of Germany -> Savannah, GeorgiaLABORATORY EQUIPMENTHS CODE 9027801720 PKG
2020032723126Bremerhaven,Federal Republic of Germany -> Savannah, GeorgiaLABORATORY EQUIPMENTHS CODE 9027801720 PKG
2020030718126Bremerhaven,Federal Republic of Germany -> Savannah, GeorgiaLABORATORY EQUIPMENTHS CODE 9027801720 PKG
2020011719547Bremerhaven,Federal Republic of Germany -> Savannah, GeorgiaLABORATORY EQUIPMENTHS CODE 9027801720 PKG
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