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    <basicUdiDi>B-M749101050111</basicUdiDi>
    <tradeName>ANCA Ethanol Fluorescent Test System</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Immuno Concepts N.A., Ltd.</manufacturerName>
    <manufacturerSrn>US-MF-000054193</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>101050-11</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T19:20:33.789Z</lastUpdated>
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    <udiDi>M749102100111</udiDi>
    <basicUdiDi>B-M749102100111</basicUdiDi>
    <tradeName>ANCA Ethanol Fluorescent Test System</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Immuno Concepts N.A., Ltd.</manufacturerName>
    <manufacturerSrn>US-MF-000054193</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>102100-11</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T19:19:43.396Z</lastUpdated>
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    <udiDi>M74910350111</udiDi>
    <basicUdiDi>B-M74910350111</basicUdiDi>
    <tradeName>ANCA Ethanol Fluorescent Test System</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Immuno Concepts N.A., Ltd.</manufacturerName>
    <manufacturerSrn>US-MF-000054193</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10350-11</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T19:19:29.618Z</lastUpdated>
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    <udiDi>M74910700111</udiDi>
    <basicUdiDi>B-M74910700111</basicUdiDi>
    <tradeName>ANCA Ethanol Fluorescent Test System</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Immuno Concepts N.A., Ltd.</manufacturerName>
    <manufacturerSrn>US-MF-000054193</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10700-11</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T19:19:13.739Z</lastUpdated>
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    <udiDi>M74910140111</udiDi>
    <basicUdiDi>B-M74910140111</basicUdiDi>
    <tradeName>ANCA Ethanol Fluorescent Test System</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Immuno Concepts N.A., Ltd.</manufacturerName>
    <manufacturerSrn>US-MF-000054193</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10140-11</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T19:16:12.801Z</lastUpdated>
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    <udiDi>M74910070111</udiDi>
    <basicUdiDi>B-M74910070111</basicUdiDi>
    <tradeName>ANCA Ethanol Fluorescent Test System</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Immuno Concepts N.A., Ltd.</manufacturerName>
    <manufacturerSrn>US-MF-000054193</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10070-11</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T19:16:10.842Z</lastUpdated>
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    <udiDi>M749100091111</udiDi>
    <basicUdiDi>B-M749100091111</basicUdiDi>
    <tradeName>ANCA Ethanol Fluorescent Test System</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Immuno Concepts N.A., Ltd.</manufacturerName>
    <manufacturerSrn>US-MF-000054193</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10009-11 (1)</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T19:16:10.274Z</lastUpdated>
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    <udiDi>M749122610211</udiDi>
    <basicUdiDi>B-M749122610211</basicUdiDi>
    <tradeName>HISTOFLUOR® Rodent LKS Fluorescent Autoantibody Test System</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Immuno Concepts N.A., Ltd.</manufacturerName>
    <manufacturerSrn>US-MF-000054193</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>12261-02 (1)</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T18:45:14.077Z</lastUpdated>
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    <udiDi>M749120210211</udiDi>
    <basicUdiDi>B-M749120210211</basicUdiDi>
    <tradeName>HISTOFLUOR® Rodent LKS Fluorescent Autoantibody Test System</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Immuno Concepts N.A., Ltd.</manufacturerName>
    <manufacturerSrn>US-MF-000054193</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>12021-02 (1)</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T18:45:12.226Z</lastUpdated>
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  <row>
    <udiDi>M7491003121</udiDi>
    <basicUdiDi>B-M7491003121</basicUdiDi>
    <tradeName>ANCA Ethanol Fluorescent Test System</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Immuno Concepts N.A., Ltd.</manufacturerName>
    <manufacturerSrn>US-MF-000054193</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10031 (2)</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T18:44:58.794Z</lastUpdated>
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    <udiDi>M7491010011</udiDi>
    <basicUdiDi>B-M7491010011</basicUdiDi>
    <tradeName>ANCA Ethanol Fluorescent Test System</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Immuno Concepts N.A., Ltd.</manufacturerName>
    <manufacturerSrn>US-MF-000054193</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10100 (1)</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T18:44:57.863Z</lastUpdated>
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  <row>
    <udiDi>M74910350L111</udiDi>
    <basicUdiDi>B-M74910350L111</basicUdiDi>
    <tradeName>ANCA Ethanol Fluorescent Test System</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Immuno Concepts N.A., Ltd.</manufacturerName>
    <manufacturerSrn>US-MF-000054193</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10350L-11</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T18:44:57.252Z</lastUpdated>
  </row>
  <row>
    <udiDi>M74910700L111</udiDi>
    <basicUdiDi>B-M74910700L111</basicUdiDi>
    <tradeName>ANCA Ethanol Fluorescent Test System</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Immuno Concepts N.A., Ltd.</manufacturerName>
    <manufacturerSrn>US-MF-000054193</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10700L-11</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T18:44:56.769Z</lastUpdated>
  </row>
  <row>
    <udiDi>M74910140L111</udiDi>
    <basicUdiDi>B-M74910140L111</basicUdiDi>
    <tradeName>ANCA Ethanol Fluorescent Test System</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Immuno Concepts N.A., Ltd.</manufacturerName>
    <manufacturerSrn>US-MF-000054193</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10140L-11</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T18:44:56.149Z</lastUpdated>
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  <row>
    <udiDi>M74910070L111</udiDi>
    <basicUdiDi>B-M74910070L111</basicUdiDi>
    <tradeName>ANCA Ethanol Fluorescent Test System</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Immuno Concepts N.A., Ltd.</manufacturerName>
    <manufacturerSrn>US-MF-000054193</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10070L-11</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T18:44:55.111Z</lastUpdated>
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  <row>
    <udiDi>M749100211221</udiDi>
    <basicUdiDi>B-M749100211221</basicUdiDi>
    <tradeName>ANCA Ethanol Fluorescent Test System</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Immuno Concepts N.A., Ltd.</manufacturerName>
    <manufacturerSrn>US-MF-000054193</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10021-12 (2)</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T18:44:44.481Z</lastUpdated>
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  <row>
    <udiDi>M749100261221</udiDi>
    <basicUdiDi>B-M749100261221</basicUdiDi>
    <tradeName>ANCA Ethanol Fluorescent Test System</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Immuno Concepts N.A., Ltd.</manufacturerName>
    <manufacturerSrn>US-MF-000054193</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10026-12 (2)</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T18:44:42.670Z</lastUpdated>
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    <udiDi>M749100211121</udiDi>
    <basicUdiDi>B-M749100211121</basicUdiDi>
    <tradeName>ANCA Ethanol Fluorescent Test System</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Immuno Concepts N.A., Ltd.</manufacturerName>
    <manufacturerSrn>US-MF-000054193</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10021-11 (2)</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T18:43:16.940Z</lastUpdated>
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    <udiDi>M749100261121</udiDi>
    <basicUdiDi>B-M749100261121</basicUdiDi>
    <tradeName>ANCA Ethanol Fluorescent Test System</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Immuno Concepts N.A., Ltd.</manufacturerName>
    <manufacturerSrn>US-MF-000054193</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10026-11 (2)</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T18:43:09.016Z</lastUpdated>
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    <udiDi>M74910350121</udiDi>
    <basicUdiDi>B-M74910350121</basicUdiDi>
    <tradeName>ANCA Formalin Fluorescent Test System</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Immuno Concepts N.A., Ltd.</manufacturerName>
    <manufacturerSrn>US-MF-000054193</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10350-12</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T18:43:07.981Z</lastUpdated>
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