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<eudamedExport entity="devices">
  <row>
    <udiDi>06944904037721</udiDi>
    <basicUdiDi>69449040004EFUN********G8</basicUdiDi>
    <tradeName>Fructosamine (FUN) Kit (Colorimetric Assay)</tradeName>
    <deviceName>Fructosamine (FUN) Kit (Colorimetric Assay)、FUN Control</deviceName>
    <manufacturerName>Shenzhen Mindray Bio-Medical Electronics Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014156</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01010210</emdnCode>
    <emdnDescription>FRUCTOSAMINE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>105-002195-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T16:44:11.730Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-R063162F</udiDi>
    <basicUdiDi>B-R063162F</basicUdiDi>
    <tradeName>D-R063162F</tradeName>
    <deviceName>Fructosamine Assay Reagent Kit (NBT Method)</deviceName>
    <manufacturerName>Rayto Life and Analytical Sciences Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000011141</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010210</emdnCode>
    <emdnDescription>FRUCTOSAMINE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R06316</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-22T11:55:20.072Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-R063152D</udiDi>
    <basicUdiDi>B-R063152D</basicUdiDi>
    <tradeName>D-R063152D</tradeName>
    <deviceName>Fructosamine Assay Reagent Kit (NBT Method)</deviceName>
    <manufacturerName>Rayto Life and Analytical Sciences Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000011141</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010210</emdnCode>
    <emdnDescription>FRUCTOSAMINE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R06315</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-22T11:55:16.163Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-R063142B</udiDi>
    <basicUdiDi>B-R063142B</basicUdiDi>
    <tradeName>D-R063142B</tradeName>
    <deviceName>Fructosamine Assay Reagent Kit (NBT Method)</deviceName>
    <manufacturerName>Rayto Life and Analytical Sciences Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000011141</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010210</emdnCode>
    <emdnDescription>FRUCTOSAMINE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R06314</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-22T11:55:15.284Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-R0631227</udiDi>
    <basicUdiDi>B-R0631227</basicUdiDi>
    <tradeName>D-R0631227</tradeName>
    <deviceName>Fructosamine Assay Reagent Kit (NBT Method)</deviceName>
    <manufacturerName>Rayto Life and Analytical Sciences Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000011141</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010210</emdnCode>
    <emdnDescription>FRUCTOSAMINE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R06312</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-22T11:55:14.471Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-R0631125</udiDi>
    <basicUdiDi>B-R0631125</basicUdiDi>
    <tradeName>D-R0631125</tradeName>
    <deviceName>Fructosamine Assay Reagent Kit (NBT Method)</deviceName>
    <manufacturerName>Rayto Life and Analytical Sciences Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000011141</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010210</emdnCode>
    <emdnDescription>FRUCTOSAMINE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R06311</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-22T11:55:13.689Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-FRUTTOSAMINA-LRKJ</udiDi>
    <basicUdiDi>B-FRUTTOSAMINA-LRKJ</basicUdiDi>
    <tradeName>FRUTTOSAMINA LR</tradeName>
    <deviceName>FRUTTOSAMINA LR</deviceName>
    <manufacturerName>FUTURLAB S.R.L.</manufacturerName>
    <manufacturerSrn>IT-MF-000046539</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010210</emdnCode>
    <emdnDescription>FRUCTOSAMINE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FCC246-2</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-13T18:46:49.739Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-FMN601CA</udiDi>
    <basicUdiDi>B-FMN601CA</basicUdiDi>
    <tradeName>Fructosamine Reagent Kit</tradeName>
    <deviceName>Fructosamine Reagent Kit</deviceName>
    <manufacturerName>Hangzhou Aichek Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000028093</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010210</emdnCode>
    <emdnDescription>FRUCTOSAMINE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FMN6011Y, FMN6012Y, FMN6013Y, FMN6014Y, FMN6015Y, FMN6011N, FMN6012N, FMN6013N, FMN6014N, FMN6015N</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T18:36:50.302Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ECH05031106D</udiDi>
    <basicUdiDi>B-ECH05031106D</basicUdiDi>
    <tradeName>D-ECH05031106D</tradeName>
    <deviceName>Fructosamine (FMN)</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010210</emdnCode>
    <emdnDescription>FRUCTOSAMINE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ECH0503110</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:44:31.748Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ECH050211066</udiDi>
    <basicUdiDi>B-ECH050211066</basicUdiDi>
    <tradeName>D-ECH050211066</tradeName>
    <deviceName>Fructosamine (FMN)</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010210</emdnCode>
    <emdnDescription>FRUCTOSAMINE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ECH0502110</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:43:42.746Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ECH05011105X</udiDi>
    <basicUdiDi>B-ECH05011105X</basicUdiDi>
    <tradeName>D-ECH05011105X</tradeName>
    <deviceName>Fructosamine (FMN)</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010210</emdnCode>
    <emdnDescription>FRUCTOSAMINE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ECH0501110</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:43:09.938Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ECH01051035A</udiDi>
    <basicUdiDi>B-ECH01051035A</basicUdiDi>
    <tradeName>D-ECH01051035A</tradeName>
    <deviceName>Fructosamine (FMN)</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010210</emdnCode>
    <emdnDescription>FRUCTOSAMINE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ECH0105103</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:36:24.090Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ECH01021034M</udiDi>
    <basicUdiDi>B-ECH01021034M</basicUdiDi>
    <tradeName>D-ECH01021034M</tradeName>
    <deviceName>Fructosamine (FMN)</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010210</emdnCode>
    <emdnDescription>FRUCTOSAMINE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ECH0102103</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:35:12.257Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-ECH01011034E</udiDi>
    <basicUdiDi>B-ECH01011034E</basicUdiDi>
    <tradeName>D-ECH01011034E</tradeName>
    <deviceName>Fructosamine (FMN)</deviceName>
    <manufacturerName>Maccura Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014618</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010210</emdnCode>
    <emdnDescription>FRUCTOSAMINE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ECH0101103</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T15:33:41.911Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-77942K9</udiDi>
    <basicUdiDi>B-77942K9</basicUdiDi>
    <tradeName>SPOTCHEM D FRA</tradeName>
    <deviceName>SPOTCHEM D FRA</deviceName>
    <manufacturerName>ARKRAY Factory, Inc.</manufacturerName>
    <manufacturerSrn>JP-MF-000003008</manufacturerSrn>
    <authorisedRepresentativeName>ARKRAY Europe, B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002056</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010210</emdnCode>
    <emdnDescription>FRUCTOSAMINE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>77942</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:24:53.948Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-77413J9</udiDi>
    <basicUdiDi>B-77413J9</basicUdiDi>
    <tradeName>SPOTCHEM II Fructosamine</tradeName>
    <deviceName>SPOTCHEM II Fructosamine</deviceName>
    <manufacturerName>ARKRAY Factory, Inc.</manufacturerName>
    <manufacturerSrn>JP-MF-000003008</manufacturerSrn>
    <authorisedRepresentativeName>ARKRAY Europe, B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002056</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010210</emdnCode>
    <emdnDescription>FRUCTOSAMINE</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>77413</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:22:27.328Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-77178JN</udiDi>
    <basicUdiDi>B-77178JN</basicUdiDi>
    <tradeName>SPOTCHEM II Fructosamine</tradeName>
    <deviceName>SPOTCHEM II Fructosamine</deviceName>
    <manufacturerName>ARKRAY Factory, Inc.</manufacturerName>
    <manufacturerSrn>JP-MF-000003008</manufacturerSrn>
    <authorisedRepresentativeName>ARKRAY Europe, B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002056</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010210</emdnCode>
    <emdnDescription>FRUCTOSAMINE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>77178</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:19:52.114Z</lastUpdated>
  </row>
  <row>
    <udiDi>08435287110463</udiDi>
    <basicUdiDi>B-08435287110463</basicUdiDi>
    <tradeName>08435287110463</tradeName>
    <deviceName>FRUCTOSAMINE</deviceName>
    <manufacturerName>BIOSYSTEMS S.A.</manufacturerName>
    <manufacturerSrn>ES-MF-000000231</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010210</emdnCode>
    <emdnDescription>FRUCTOSAMINE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>11046</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-07T20:43:22.757Z</lastUpdated>
  </row>
  <row>
    <udiDi>08053172972929</udiDi>
    <basicUdiDi>B-08053172972929</basicUdiDi>
    <tradeName>Fruttosamina - Biotecnica Systems</tradeName>
    <deviceName>Fruttosamina/Fructosamine - Biotecnica Systems</deviceName>
    <manufacturerName>GIESSE DIAGNOSTICS SRL</manufacturerName>
    <manufacturerSrn>IT-MF-000039031</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010210</emdnCode>
    <emdnDescription>FRUCTOSAMINE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BT5531</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-07T16:49:05.592Z</lastUpdated>
  </row>
  <row>
    <udiDi>08053172970475</udiDi>
    <basicUdiDi>B-08053172970475</basicUdiDi>
    <tradeName>Fruttosamina</tradeName>
    <deviceName>Fruttosamina/Fructosamine</deviceName>
    <manufacturerName>GIESSE DIAGNOSTICS SRL</manufacturerName>
    <manufacturerSrn>IT-MF-000039031</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010210</emdnCode>
    <emdnDescription>FRUCTOSAMINE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5531</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-07T16:42:39.555Z</lastUpdated>
  </row>
</eudamedExport>