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    TEM Innovations GmbH

    FDA registration
    TEM Innovations GmbH·2 products·🇩🇪 Germany

    ROTEM®

    FDA UDI
    Tem Innovations GmbH·04260160470044·The ROTEM® delta is designed for in-vitro diagn...

    ROTEM®

    FDA UDI
    Tem Innovations GmbH·04260160470099·The ROTEM® delta is designed for in-vitro diagn...

    ROTEM®

    FDA UDI
    Tem Innovations GmbH·04260160470105·ROTROL N is a quality control material for moni...

    ROTEM®

    FDA UDI
    Tem Innovations GmbH·04260160470112·ROTROL P is a quality control material for moni...

    ROTEM®

    FDA UDI
    Tem Innovations GmbH·04260160470020·The ROTEM® delta is designed for in-vitro diagn...

    ROTEM®

    FDA UDI
    Tem Innovations GmbH·04260160470327·The ROTEM sigma is an in vitro diagnostic (IVD)...

    ROTEM®

    FDA UDI
    Tem Innovations GmbH·04260160470358·The ROTEM sigma is an in vitro diagnostic (IVD)...

    ROTEM®

    FDA UDI
    Tem Innovations GmbH·04260160470242·The EXTEM assay is a semi-quantitative in vitro...

    ROTEM®

    FDA UDI
    Tem Innovations GmbH·04260160470082·The ROTEM® delta is designed for in-vitro diagn...

    ROTEM®

    FDA UDI
    Tem Innovations GmbH·04260160470587·The ROTEM® delta is designed for in-vitro diagn...

    ROTEM®

    FDA UDI
    Tem Innovations GmbH·04260160470075·The FIBTEM assay is a semi-quantitative in vitr...

    ROTEM®

    FDA UDI
    Tem Innovations GmbH·04260160470372·The ROTEM sigma is an in vitro diagnostic (IVD)...

    ROTEM®

    FDA UDI
    Tem Innovations GmbH·04260160470068·The APTEM assay is a semi-quantitative in vitro...

    ROTEM®

    FDA UDI
    Tem Innovations GmbH·04260160470341·The ROTEM sigma is an in vitro diagnostic (IVD)...

    ROTEM DELTA SYSTEM

    FDA Adverse Event
    Injury ·TEM INNOVATIONS GMBH·Product code JPA·August 31, 2018

    ROTEM DELTA SYSTEM

    FDA Adverse Event
    Malfunction ·TEM INNOVATIONS GMBH·Product code JPA·May 16, 2018

    ROTEM SIGMA SYSTEM

    FDA Adverse Event
    Malfunction ·TEM INNOVATIONS GMBH·Product code JPA·November 17, 2023

    ROTEM DELTA SYSTEM

    FDA Adverse Event
    Death ·TEM INNOVATIONS GMBH·Product code JPA·March 17, 2026

    ROTEM DELTA SYSTEM

    FDA Adverse Event
    Malfunction ·TEM INNOVATIONS GMBH·Product code JPA·February 9, 2018