Tem Innovations G M B H

FDA Filings

This page includes the latest FDA filings for Tem Innovations G M B H. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)
Registration Number3005792925
FEI Number3005792925
NameTEM Innovations GmbH
Owner & OperatorTEM Innovations GmbH
Contact AddressMartin-Kollar-Strasse 15
Munich DE-BY Bayern 81829 DE
Official Correspondent
  • Volker-Joachim Friemert
  • 49-89-45429511-x
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration AddressMartin-Kollar Strasse, 15
Munich Bayern, 81829 DE
Establishment TypeDevelop Specifications But Do Not Manufacture At This Facility



FDA Filings

Device
Company
DeviceDate
Tem Innovations GmbH
ROTEM Sigma Thromboelastometry System2022-07-08
Tem Innovations GmbH
ROTEM® 2010012020-02-03
Tem Innovations GmbH
ROTEM® 503-05-US2018-07-06
Tem Innovations GmbH
ROTEM® 503-25-US2018-07-06
Tem Innovations GmbH
ROTEM® 503-24-US2018-07-06
Tem Innovations GmbH
ROTEM® 503-10-US2018-07-06
Tem Innovations GmbH
ROTEM® 503-09-US2018-07-06
Tem Innovations GmbH
ROTEM® 503-06-US2018-07-06
Tem Innovations GmbH
ROTEM® 503-04-US2018-07-06
Tem Innovations GmbH
ROTEM® 503-02-US2018-07-06
Tem Innovations GmbH
ROTEM® 200100-US2018-07-06
TEM Innovations GmbH
EX-TEM. FIB-TEM, AND AP-TEM FOR ROTEM DELTA THROMBOELASTOMET2011-09-19
Tem Innovations GmbH
EX-TEM. FIB-TEM, AND AP-TEM FOR ROTEM DELTA THROMBOELASTOMETRY SYSTEM2011-08-10
TEM Innovations GmbH
star-TEM2010-03-25
TEM Innovations GmbH
in-TEM Assay2010-03-25
TEM Innovations GmbH
hep-TEM Assay2010-03-25
TEM Innovations GmbH
ROTROL P2010-03-25
TEM Innovations GmbH
ROTROL N2010-03-25
TEM Innovations GmbH
ROTEM Delta Instrument2010-03-25
TEM Innovations GmbH
NATEM Assay2010-03-25
TEM Innovations GmbH
star-TEM2010-03-25
TEM Innovations GmbH
in-TEM Assay2010-03-25
TEM Innovations GmbH
hep-TEM Assay2010-03-25
TEM Innovations GmbH
ROTROL P2010-03-25
TEM Innovations GmbH
ROTROL N2010-03-25
TEM Innovations GmbH
ROTEM Delta Instrument2010-03-25
TEM Innovations GmbH
NATEM Assay2010-03-25

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