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<eudamedExport entity="devices">
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    <udiDi>B350003500</udiDi>
    <basicUdiDi>++B35000350BF</basicUdiDi>
    <tradeName>HAILSTORM</tradeName>
    <deviceName>HAILSTORM</deviceName>
    <manufacturerName>Gold Standard Diagnostics, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000027142</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201020101</emdnCode>
    <emdnDescription>AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput &lt;= 100 test/h)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>00350</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T11:54:03.790Z</lastUpdated>
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  <row>
    <udiDi>B35000300CL0</udiDi>
    <basicUdiDi>++B35000300CLHZ</basicUdiDi>
    <tradeName>ThunderBolt EIA (CLIA)</tradeName>
    <deviceName>ThunderBolt EIA (CLIA)</deviceName>
    <manufacturerName>Gold Standard Diagnostics, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000027142</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201020101</emdnCode>
    <emdnDescription>AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput &lt;= 100 test/h)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>00300-CL</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T11:54:02.035Z</lastUpdated>
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  <row>
    <udiDi>B350003000</udiDi>
    <basicUdiDi>++B35000300AY</basicUdiDi>
    <tradeName>ThunderBolt EIA</tradeName>
    <deviceName>ThunderBolt EIA</deviceName>
    <manufacturerName>Gold Standard Diagnostics, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000027142</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201020101</emdnCode>
    <emdnDescription>AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput &lt;= 100 test/h)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>00300</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T11:54:01.071Z</lastUpdated>
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  <row>
    <udiDi>111938738460</udiDi>
    <basicUdiDi>PP13707READER74</basicUdiDi>
    <tradeName>111938738460</tradeName>
    <deviceName>Ledetect96</deviceName>
    <manufacturerName>biomed Dr. Wieser GmbH</manufacturerName>
    <manufacturerSrn>AT-MF-000028269</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201020201</emdnCode>
    <emdnDescription>IMMUNOCHEMISTRY READERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Many</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-15T11:43:56.119Z</lastUpdated>
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  <row>
    <udiDi>D-uRIQUICKU8</udiDi>
    <basicUdiDi>B-uRIQUICKU8</basicUdiDi>
    <tradeName>uRI QUICK</tradeName>
    <deviceName>uRI QUICK PRO UA14</deviceName>
    <manufacturerName>STRUmed Solutions Private Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000023119</manufacturerSrn>
    <authorisedRepresentativeName>Amstermed B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001971</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W02010701</emdnCode>
    <emdnDescription>URINALYSIS (UR) - LABORATORY ANALYSERS- INSTRUMENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>uRI QUICK PRO UA14</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-07-15T11:31:26.967Z</lastUpdated>
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  <row>
    <udiDi>D-iNSTAXPLORPF8</udiDi>
    <basicUdiDi>B-iNSTAXPLORPF8</basicUdiDi>
    <tradeName>iNSTA XPLOR® P</tradeName>
    <deviceName>iNSTA XPLOR P PA 001</deviceName>
    <manufacturerName>STRUmed Solutions Private Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000023119</manufacturerSrn>
    <authorisedRepresentativeName>Amstermed B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001971</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0201020204</emdnCode>
    <emdnDescription>NEPHELOMETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>iNSTA XPLOR® P PA 001</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-07-15T11:19:48.957Z</lastUpdated>
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  <row>
    <udiDi>D-VSG01D-2MH</udiDi>
    <basicUdiDi>B-VSG01D-2MH</basicUdiDi>
    <tradeName>BeneCheck Blood Glucose Monitoring System</tradeName>
    <deviceName>Blood glucose monitoring system</deviceName>
    <manufacturerName>General Life Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>TW-MF-000027109</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0201060102</emdnCode>
    <emdnDescription>BLOOD GLUCOSE METERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VSG01D-2</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T10:27:40.670Z</lastUpdated>
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  <row>
    <udiDi>D-VSG010-2JJ</udiDi>
    <basicUdiDi>B-VSG010-2JJ</basicUdiDi>
    <tradeName>BeneCheck Blood Glucose Monitoring System</tradeName>
    <deviceName>Blood glucose monitoring system</deviceName>
    <manufacturerName>General Life Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>TW-MF-000027109</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0201060102</emdnCode>
    <emdnDescription>BLOOD GLUCOSE METERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VSG010-2</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T10:27:38.153Z</lastUpdated>
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  <row>
    <udiDi>D-T05H7990073KNX5</udiDi>
    <basicUdiDi>B-T05H7990073KNX5</basicUdiDi>
    <tradeName>Soludiab</tradeName>
    <deviceName>LGLMV-02 Blood Glucose Monitoring System</deviceName>
    <manufacturerName>Tyson Bioresearch, Inc.</manufacturerName>
    <manufacturerSrn>TW-MF-000027508</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0201060102</emdnCode>
    <emdnDescription>BLOOD GLUCOSE METERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LGLMV-02</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-15T07:52:39.736Z</lastUpdated>
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  <row>
    <udiDi>D-T05H1690071KNQQ</udiDi>
    <basicUdiDi>B-T05H1690071KNQQ</basicUdiDi>
    <tradeName>Rossmax</tradeName>
    <deviceName>Rossmax HS200 Blood Glucose Monitoring System</deviceName>
    <manufacturerName>Tyson Bioresearch, Inc.</manufacturerName>
    <manufacturerSrn>TW-MF-000027508</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0201060102</emdnCode>
    <emdnDescription>BLOOD GLUCOSE METERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BGM_KIT_002_RM</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-15T07:52:36.358Z</lastUpdated>
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  <row>
    <udiDi>D-T05H1690070KNQK</udiDi>
    <basicUdiDi>B-T05H1690070KNQK</basicUdiDi>
    <tradeName>Rossmax</tradeName>
    <deviceName>Rossmax HS200 Blood Glucose Monitoring System</deviceName>
    <manufacturerName>Tyson Bioresearch, Inc.</manufacturerName>
    <manufacturerSrn>TW-MF-000027508</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Kendi Kendine Test</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0201060102</emdnCode>
    <emdnDescription>BLOOD GLUCOSE METERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BGM_KIT_004_RM</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-15T07:52:34.128Z</lastUpdated>
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  <row>
    <udiDi>D-T05H1690041KNQ3</udiDi>
    <basicUdiDi>B-T05H1690041KNQ3</basicUdiDi>
    <tradeName>Rossmax</tradeName>
    <deviceName>Rossmax HS200 Blood Glucose Monitoring System</deviceName>
    <manufacturerName>Tyson Bioresearch, Inc.</manufacturerName>
    <manufacturerSrn>TW-MF-000027508</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0201060102</emdnCode>
    <emdnDescription>BLOOD GLUCOSE METERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BGM_KIT_001_RM</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-15T07:52:28.524Z</lastUpdated>
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  <row>
    <udiDi>D-T05H1690040KNPW</udiDi>
    <basicUdiDi>B-T05H1690040KNPW</basicUdiDi>
    <tradeName>Rossmax</tradeName>
    <deviceName>Rossmax HS200 Blood Glucose Monitoring System</deviceName>
    <manufacturerName>Tyson Bioresearch, Inc.</manufacturerName>
    <manufacturerSrn>TW-MF-000027508</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0201060102</emdnCode>
    <emdnDescription>BLOOD GLUCOSE METERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BGM_KIT_002_RM</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-15T07:52:27.748Z</lastUpdated>
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  <row>
    <udiDi>D-T05G2J10011KNW9</udiDi>
    <basicUdiDi>B-T05G2J10011KNW9</basicUdiDi>
    <tradeName>Soludiab</tradeName>
    <deviceName>LGLMV-BT-01 Blood Glucose Monitoring System</deviceName>
    <manufacturerName>Tyson Bioresearch, Inc.</manufacturerName>
    <manufacturerSrn>TW-MF-000027508</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0201060102</emdnCode>
    <emdnDescription>BLOOD GLUCOSE METERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LGLMV‐BT‐01</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-15T07:52:26.127Z</lastUpdated>
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    <udiDi>D-T05D5900001KBJP</udiDi>
    <basicUdiDi>B-T05D5900001KBJP</basicUdiDi>
    <tradeName>plusMED fasTTest</tradeName>
    <deviceName>plusMED fasTTest Blood Glucose Monitoring System</deviceName>
    <manufacturerName>Tyson Bioresearch, Inc.</manufacturerName>
    <manufacturerSrn>TW-MF-000027508</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0201060102</emdnCode>
    <emdnDescription>BLOOD GLUCOSE METERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>pM-100</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-15T07:50:52.188Z</lastUpdated>
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    <udiDi>D-T05D5710001KNJS</udiDi>
    <basicUdiDi>B-T05D5710001KNJS</basicUdiDi>
    <tradeName>Spengler TB100</tradeName>
    <deviceName>Spengler TB100 Blood Glucose Monitoring System</deviceName>
    <manufacturerName>Tyson Bioresearch, Inc.</manufacturerName>
    <manufacturerSrn>TW-MF-000027508</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0201060102</emdnCode>
    <emdnDescription>BLOOD GLUCOSE METERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>745000</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-15T07:50:47.378Z</lastUpdated>
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    <udiDi>D-SL-25-IFIXNF</udiDi>
    <basicUdiDi>B-SL-25-IFIXNF</basicUdiDi>
    <tradeName>D-SL-25-IFIXNF</tradeName>
    <deviceName>Immunofixation electrophoresis kit 25 tests</deviceName>
    <manufacturerName>Seleo S.r.l.</manufacturerName>
    <manufacturerSrn>IT-MF-000045668</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0201050101</emdnCode>
    <emdnDescription>AUTOMATED ELECTROPHORESIS SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SL-25-IFIX</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-15T03:30:33.603Z</lastUpdated>
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    <udiDi>D-SELVET242D</udiDi>
    <basicUdiDi>B-SELVET242D</basicUdiDi>
    <tradeName>D-SELVET242D</tradeName>
    <deviceName>Selvet 24</deviceName>
    <manufacturerName>Seleo S.r.l.</manufacturerName>
    <manufacturerSrn>IT-MF-000045668</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0201050101</emdnCode>
    <emdnDescription>AUTOMATED ELECTROPHORESIS SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SLV24</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-15T03:13:30.024Z</lastUpdated>
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    <udiDi>D-PartnumberA097916X</udiDi>
    <basicUdiDi>B-PartnumberA097916X</basicUdiDi>
    <tradeName>IMMAGE UDR Kit (1-pack)</tradeName>
    <deviceName>IMMAGE UDR Kit (1-pack)</deviceName>
    <manufacturerName>Beckman Coulter Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010288</manufacturerSrn>
    <authorisedRepresentativeName>Beckman Coulter Ireland Inc.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000886</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0201010185</emdnCode>
    <emdnDescription>CHEMISTRY ANALYSERS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A09791</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-15T02:22:19.710Z</lastUpdated>
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    <udiDi>06978274250411</udiDi>
    <basicUdiDi>6978274250000DG</basicUdiDi>
    <tradeName>Rapid Test Reader</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ACtest Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000049724</manufacturerSrn>
    <authorisedRepresentativeName>VidaQuick Biotech S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000048138</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201020201</emdnCode>
    <emdnDescription>IMMUNOCHEMISTRY READERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>aca-A02</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-14T19:54:52.460Z</lastUpdated>
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