<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>00894472000800</udiDi>
    <basicUdiDi>B-00894472000800</basicUdiDi>
    <tradeName>OPTI CCA E-LYTE CASSETTE</tradeName>
    <deviceName>OPTI CCA E-LYTE CASSETTE</deviceName>
    <manufacturerName>OPTI Medical Systems, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000027152</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0580</emdnCode>
    <emdnDescription>IVD GENERAL USE CONSUMABLES DEVICES - OTHER ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BP7667</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T13:02:11.717Z</lastUpdated>
  </row>
  <row>
    <udiDi>00894472000749</udiDi>
    <basicUdiDi>B-00894472000749</basicUdiDi>
    <tradeName>OPTI CCA -TS2 ANALYZER CALIBRATION GAS</tradeName>
    <deviceName>OPTI CCA -TS2 ANALYZER CALIBRATION GAS</deviceName>
    <manufacturerName>OPTI Medical Systems, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000027152</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0580</emdnCode>
    <emdnDescription>IVD GENERAL USE CONSUMABLES DEVICES - OTHER ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BP7162</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T13:02:10.118Z</lastUpdated>
  </row>
  <row>
    <udiDi>00894472000718</udiDi>
    <basicUdiDi>B-00894472000718</basicUdiDi>
    <tradeName>OPTI CCA-TS2 Hb Cal Cassette</tradeName>
    <deviceName>OPTI CCA-TS2 Hb Cal Cassette</deviceName>
    <manufacturerName>OPTI Medical Systems, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000027152</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0580</emdnCode>
    <emdnDescription>IVD GENERAL USE CONSUMABLES DEVICES - OTHER ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BP7653</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T13:02:09.315Z</lastUpdated>
  </row>
  <row>
    <udiDi>00894472000701</udiDi>
    <basicUdiDi>B-00894472000701</basicUdiDi>
    <tradeName>OPTI CCA-TS2 MULTI-LEVEL SRC</tradeName>
    <deviceName>OPTI CCA-TS2 MULTI-LEVEL SRC</deviceName>
    <manufacturerName>OPTI Medical Systems, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000027152</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0580</emdnCode>
    <emdnDescription>IVD GENERAL USE CONSUMABLES DEVICES - OTHER ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BP7652</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T13:02:07.715Z</lastUpdated>
  </row>
  <row>
    <udiDi>00894472000695</udiDi>
    <basicUdiDi>B-00894472000695</basicUdiDi>
    <tradeName>OPTI CCA B-60 CASSETTE</tradeName>
    <deviceName>OPTI CCA B-60 CASSETTE</deviceName>
    <manufacturerName>OPTI Medical Systems, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000027152</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0580</emdnCode>
    <emdnDescription>IVD GENERAL USE CONSUMABLES DEVICES - OTHER ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BP7586</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T13:02:05.310Z</lastUpdated>
  </row>
  <row>
    <udiDi>00894472000688</udiDi>
    <basicUdiDi>B-00894472000688</basicUdiDi>
    <tradeName>OPTI CCA B-LAC CASSETTE</tradeName>
    <deviceName>OPTI CCA B-LAC CASSETTE</deviceName>
    <manufacturerName>OPTI Medical Systems, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000027152</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0580</emdnCode>
    <emdnDescription>IVD GENERAL USE CONSUMABLES DEVICES - OTHER ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BP7561</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T13:02:03.712Z</lastUpdated>
  </row>
  <row>
    <udiDi>00894472000275</udiDi>
    <basicUdiDi>B-00894472000275</basicUdiDi>
    <tradeName>OPTI CCA E-GLU CASSETTE</tradeName>
    <deviceName>OPTI CCA E-GLU CASSETTE</deviceName>
    <manufacturerName>OPTI Medical Systems, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000027152</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0580</emdnCode>
    <emdnDescription>IVD GENERAL USE CONSUMABLES DEVICES - OTHER ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BP7564</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T13:02:02.908Z</lastUpdated>
  </row>
  <row>
    <udiDi>00894472000268</udiDi>
    <basicUdiDi>B-00894472000268</basicUdiDi>
    <tradeName>OPTI CCA E-CL CASSETTE</tradeName>
    <deviceName>OPTI CCA E-CL CASSETTE</deviceName>
    <manufacturerName>OPTI Medical Systems, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000027152</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0580</emdnCode>
    <emdnDescription>IVD GENERAL USE CONSUMABLES DEVICES - OTHER ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BP7559</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T13:02:01.309Z</lastUpdated>
  </row>
  <row>
    <udiDi>00894472000251</udiDi>
    <basicUdiDi>B-00894472000251</basicUdiDi>
    <tradeName>OPTI CCA E-CA CASSETTE</tradeName>
    <deviceName>OPTI CCA E-CA CASSETTE</deviceName>
    <manufacturerName>OPTI Medical Systems, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000027152</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0580</emdnCode>
    <emdnDescription>IVD GENERAL USE CONSUMABLES DEVICES - OTHER ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BP7560</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T13:01:58.909Z</lastUpdated>
  </row>
  <row>
    <udiDi>00894472000237</udiDi>
    <basicUdiDi>B-00894472000237</basicUdiDi>
    <tradeName>OPTI CCA CASSETTES B</tradeName>
    <deviceName>OPTI CCA B Cassette</deviceName>
    <manufacturerName>OPTI Medical Systems, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000027152</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0580</emdnCode>
    <emdnDescription>IVD GENERAL USE CONSUMABLES DEVICES - OTHER ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BP7562</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T13:01:57.306Z</lastUpdated>
  </row>
  <row>
    <udiDi>00894472000114</udiDi>
    <basicUdiDi>B-00894472000114</basicUdiDi>
    <tradeName>OPTI CHECK PLUS</tradeName>
    <deviceName>OPTI CHECK PLUS</deviceName>
    <manufacturerName>OPTI Medical Systems, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000027152</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0580</emdnCode>
    <emdnDescription>IVD GENERAL USE CONSUMABLES DEVICES - OTHER ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HC7009</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T13:01:56.504Z</lastUpdated>
  </row>
  <row>
    <udiDi>00894472000107</udiDi>
    <basicUdiDi>B-00894472000107</basicUdiDi>
    <tradeName>OPTI CHECK</tradeName>
    <deviceName>OPTI CHECK</deviceName>
    <manufacturerName>OPTI Medical Systems, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000027152</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0580</emdnCode>
    <emdnDescription>IVD GENERAL USE CONSUMABLES DEVICES - OTHER ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HC7008</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T13:01:54.899Z</lastUpdated>
  </row>
  <row>
    <udiDi>00894472000053</udiDi>
    <basicUdiDi>B-00894472000053</basicUdiDi>
    <tradeName>OPTI Hb Cal Cassette</tradeName>
    <deviceName>OPTI Hb Cal Cassette</deviceName>
    <manufacturerName>OPTI Medical Systems, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000027152</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0580</emdnCode>
    <emdnDescription>IVD GENERAL USE CONSUMABLES DEVICES - OTHER ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BP7542</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T13:01:52.499Z</lastUpdated>
  </row>
  <row>
    <udiDi>00894472000046</udiDi>
    <basicUdiDi>B-00894472000046</basicUdiDi>
    <tradeName>OPTI CCA  SRC LEVEL 1</tradeName>
    <deviceName>OPTI SRC LEVEL 1</deviceName>
    <manufacturerName>OPTI Medical Systems, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000027152</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0580</emdnCode>
    <emdnDescription>IVD GENERAL USE CONSUMABLES DEVICES - OTHER ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BP7536</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T13:01:50.902Z</lastUpdated>
  </row>
  <row>
    <udiDi>00894472000039</udiDi>
    <basicUdiDi>B-00894472000039</basicUdiDi>
    <tradeName>OPTI CCA SRC LEVEL 3</tradeName>
    <deviceName>OPTI SRC LEVEL 3</deviceName>
    <manufacturerName>OPTI Medical Systems, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000027152</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0580</emdnCode>
    <emdnDescription>IVD GENERAL USE CONSUMABLES DEVICES - OTHER ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BP7543</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T13:01:50.399Z</lastUpdated>
  </row>
  <row>
    <udiDi>00894472000022</udiDi>
    <basicUdiDi>B-00894472000022</basicUdiDi>
    <tradeName>OPTI CCA SRC LEVEL 2</tradeName>
    <deviceName>OPTI SRC LEVEL 2</deviceName>
    <manufacturerName>OPTI Medical Systems, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000027152</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0580</emdnCode>
    <emdnDescription>IVD GENERAL USE CONSUMABLES DEVICES - OTHER ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BP7554</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T13:01:48.506Z</lastUpdated>
  </row>
  <row>
    <udiDi>00894472000015</udiDi>
    <basicUdiDi>B-00894472000015</basicUdiDi>
    <tradeName>OPTI CALIBRATION GAS</tradeName>
    <deviceName>OPTI CALIBRATION GAS</deviceName>
    <manufacturerName>OPTI Medical Systems, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000027152</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0580</emdnCode>
    <emdnDescription>IVD GENERAL USE CONSUMABLES DEVICES - OTHER ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BP7001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T13:01:46.096Z</lastUpdated>
  </row>
  <row>
    <udiDi>00894472000152</udiDi>
    <basicUdiDi>00894472GD70133M</basicUdiDi>
    <tradeName>OPTI CCA -TS Blood Gas Analyzer</tradeName>
    <deviceName></deviceName>
    <manufacturerName>OPTI Medical Systems, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000027152</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GD7013</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T02:35:49.787Z</lastUpdated>
  </row>
  <row>
    <udiDi>00894472000732</udiDi>
    <basicUdiDi>00894472GD704644</basicUdiDi>
    <tradeName>OPTI CCA -TS2 Blood Gas Analyzer</tradeName>
    <deviceName></deviceName>
    <manufacturerName>OPTI Medical Systems, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000027152</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GD7046</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T02:35:49.754Z</lastUpdated>
  </row>
</eudamedExport>