<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>04260160470372</udiDi>
    <basicUdiDi>4260160470372RT</basicUdiDi>
    <tradeName>ROTEM® sigma</tradeName>
    <deviceName>ROTEM® sigma</deviceName>
    <manufacturerName>Tem Innovations GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000012176</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0202029001</emdnCode>
    <emdnDescription>THROMBELASTOGRAPHS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>211000</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T22:39:25.036Z</lastUpdated>
  </row>
  <row>
    <udiDi>04260160470150</udiDi>
    <basicUdiDi>4260160470150R7</basicUdiDi>
    <tradeName>Cup &amp; Pin pro</tradeName>
    <deviceName>Cup &amp; Pin pro</deviceName>
    <manufacturerName>Tem Innovations GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000012176</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0503010280</emdnCode>
    <emdnDescription>SAMPLES ANALYSES, PLASTIC CONTAINERS - OTHER ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>200011</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T22:39:24.234Z</lastUpdated>
  </row>
  <row>
    <udiDi>04260160470136</udiDi>
    <basicUdiDi>4260160470136RD</basicUdiDi>
    <tradeName>TRIPTRAY Box eLine</tradeName>
    <deviceName>TIPTRAY Box eLine</deviceName>
    <manufacturerName>Tem Innovations GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000012176</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0503020280</emdnCode>
    <emdnDescription>PIPETTES, TIPS - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>400041</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T22:39:23.428Z</lastUpdated>
  </row>
  <row>
    <udiDi>04260160470129</udiDi>
    <basicUdiDi>4260160470129RG</basicUdiDi>
    <tradeName>TIPTRAY Refill eLine</tradeName>
    <deviceName>TIPTRAY Refill eLine</deviceName>
    <manufacturerName>Tem Innovations GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000012176</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0503020280</emdnCode>
    <emdnDescription>PIPETTES, TIPS - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>400040</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T22:39:17.845Z</lastUpdated>
  </row>
  <row>
    <udiDi>04260160470020</udiDi>
    <basicUdiDi>4260160470020QR</basicUdiDi>
    <tradeName>ROTEM® delta</tradeName>
    <deviceName>ROTEM® delta</deviceName>
    <manufacturerName>Tem Innovations GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000012176</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0202029001</emdnCode>
    <emdnDescription>THROMBELASTOGRAPHS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>200100</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-30T22:39:17.070Z</lastUpdated>
  </row>
  <row>
    <udiDi>04260160470068</udiDi>
    <basicUdiDi>B-04260160470068</basicUdiDi>
    <tradeName>ap-tem</tradeName>
    <deviceName>ap-tem</deviceName>
    <manufacturerName>Tem Innovations GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000012176</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103020899</emdnCode>
    <emdnDescription>HAEMOSTASIS RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>503-04</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T04:51:24.789Z</lastUpdated>
  </row>
</eudamedExport>