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    <udiDi>06970514081212</udiDi>
    <basicUdiDi>B-06970514081212</basicUdiDi>
    <tradeName>06970514081212</tradeName>
    <deviceName>Bacterial Endotoxin Detection Kit (CLIA)</deviceName>
    <manufacturerName>Genobio Pharmaceutical Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000027997</manufacturerSrn>
    <authorisedRepresentativeName>Caretechion GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005946</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105011799</emdnCode>
    <emdnDescription>BACTERIOLOGY IMMUNOASSAY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BECLIA-01</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-30T01:08:26.697Z</lastUpdated>
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    <udiDi>06970489560699</udiDi>
    <basicUdiDi>B-06970489560699</basicUdiDi>
    <tradeName>Carbapenem-resistant K.N.I.V.O. Detection K-Set (Lateral Flow Assay)</tradeName>
    <deviceName>Carbapenem-resistant K.N.I.V.O. Detection K-Set (Lateral Flow Assay)</deviceName>
    <manufacturerName>Beijing Gold Mountainriver Tech Development Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000028661</manufacturerSrn>
    <authorisedRepresentativeName>Caretechion GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005946</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105011799</emdnCode>
    <emdnDescription>BACTERIOLOGY IMMUNOASSAY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CP5-01</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-30T00:55:39.177Z</lastUpdated>
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  <row>
    <udiDi>06970489560453</udiDi>
    <basicUdiDi>B-06970489560453</basicUdiDi>
    <tradeName>Carbapenem-resistant OXA-23 Detection K-Set (Lateral Flow Assay)</tradeName>
    <deviceName>Carbapenem-resistant OXA-23 Detection K-Set (Lateral Flow Assay)</deviceName>
    <manufacturerName>Beijing Gold Mountainriver Tech Development Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000028661</manufacturerSrn>
    <authorisedRepresentativeName>Caretechion GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005946</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105011799</emdnCode>
    <emdnDescription>BACTERIOLOGY IMMUNOASSAY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CPO23-01</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-30T00:55:37.978Z</lastUpdated>
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    <udiDi>06970489560354</udiDi>
    <basicUdiDi>B-06970489560354</basicUdiDi>
    <tradeName>Bacterial Endotoxin Test (Chromogenic Method)</tradeName>
    <deviceName>Bacterial Endotoxin Test (Chromogenic Method)</deviceName>
    <manufacturerName>Beijing Gold Mountainriver Tech Development Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000028661</manufacturerSrn>
    <authorisedRepresentativeName>Prolinx GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005129</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105011799</emdnCode>
    <emdnDescription>BACTERIOLOGY IMMUNOASSAY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EKT-25M</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-30T00:55:36.767Z</lastUpdated>
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    <udiDi>06970489560347</udiDi>
    <basicUdiDi>B-06970489560347</basicUdiDi>
    <tradeName>Bacterial Endotoxin Test (Chromogenic Method)</tradeName>
    <deviceName>Bacterial Endotoxin Test (Chromogenic Method)</deviceName>
    <manufacturerName>Beijing Gold Mountainriver Tech Development Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000028661</manufacturerSrn>
    <authorisedRepresentativeName>Prolinx GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005129</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105011799</emdnCode>
    <emdnDescription>BACTERIOLOGY IMMUNOASSAY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EKT-12M</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-30T00:55:35.563Z</lastUpdated>
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  <row>
    <udiDi>06970489560330</udiDi>
    <basicUdiDi>B-06970489560330</basicUdiDi>
    <tradeName>Bacterial Endotoxin Test (Chromogenic Method)</tradeName>
    <deviceName>Bacterial Endotoxin Test (Chromogenic Method)</deviceName>
    <manufacturerName>Beijing Gold Mountainriver Tech Development Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000028661</manufacturerSrn>
    <authorisedRepresentativeName>Prolinx GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005129</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105011799</emdnCode>
    <emdnDescription>BACTERIOLOGY IMMUNOASSAY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EKT-10M</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-30T00:55:29.563Z</lastUpdated>
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  <row>
    <udiDi>06970489560323</udiDi>
    <basicUdiDi>B-06970489560323</basicUdiDi>
    <tradeName>Bacterial Endotoxin Test (Chromogenic Method)</tradeName>
    <deviceName>Bacterial Endotoxin Test (Chromogenic Method)</deviceName>
    <manufacturerName>Beijing Gold Mountainriver Tech Development Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000028661</manufacturerSrn>
    <authorisedRepresentativeName>Prolinx GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005129</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105011799</emdnCode>
    <emdnDescription>BACTERIOLOGY IMMUNOASSAY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EKT-5M</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-30T00:55:28.384Z</lastUpdated>
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    <udiDi>06955792731868</udiDi>
    <basicUdiDi>B-06955792731868</basicUdiDi>
    <tradeName>06955792731868</tradeName>
    <deviceName>Influenza A/B Virus Nucleic Acid Diagnostic Kit ( PCR-Fluorescence Probing)</deviceName>
    <manufacturerName>Sansure Biotech Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000011392</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105011710</emdnCode>
    <emdnDescription>HAEMOPHILUS INFLUENZAE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S3353E-24-P</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-06-28T17:32:25.017Z</lastUpdated>
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  <row>
    <udiDi>06955792731851</udiDi>
    <basicUdiDi>B-06955792731851</basicUdiDi>
    <tradeName>06955792731851</tradeName>
    <deviceName>Influenza A/B Virus Nucleic Acid Diagnostic Kit ( PCR-Fluorescence Probing)</deviceName>
    <manufacturerName>Sansure Biotech Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000011392</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105011710</emdnCode>
    <emdnDescription>HAEMOPHILUS INFLUENZAE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S3353E-48</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-06-28T17:32:21.409Z</lastUpdated>
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  <row>
    <udiDi>06952804827151</udiDi>
    <basicUdiDi>B-06952804827151</basicUdiDi>
    <tradeName>Cholera O1 Antigen Fecal Test Kit</tradeName>
    <deviceName>Cholera O1 Antigen Fecal Test Kit</deviceName>
    <manufacturerName>Assure Tech. (Hangzhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000002170</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105011799</emdnCode>
    <emdnDescription>BACTERIOLOGY IMMUNOASSAY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VCO1-F23</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-28T09:32:54.262Z</lastUpdated>
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  <row>
    <udiDi>06952804827069</udiDi>
    <basicUdiDi>B-06952804827069</basicUdiDi>
    <tradeName>Shigella Rapid Test</tradeName>
    <deviceName>Shigella Rapid Test</deviceName>
    <manufacturerName>Assure Tech. (Hangzhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000002170</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105011714</emdnCode>
    <emdnDescription>SHIGELLA</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SGL-f23</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-28T09:32:28.347Z</lastUpdated>
  </row>
  <row>
    <udiDi>06952804816704</udiDi>
    <basicUdiDi>B-06952804816704</basicUdiDi>
    <tradeName>Brucella Antiboby Test</tradeName>
    <deviceName>Brucella Antiboby Test</deviceName>
    <manufacturerName>Assure Tech. (Hangzhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000002170</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105011701</emdnCode>
    <emdnDescription>BRUCELLA</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BRU-W23</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-28T09:29:34.902Z</lastUpdated>
  </row>
  <row>
    <udiDi>06942293582044</udiDi>
    <basicUdiDi>697518250E118062F</basicUdiDi>
    <tradeName>Carbapenem Resistant Enterobacteriaceae Rapid Test Kit</tradeName>
    <deviceName>Carbapenem Resistant Enterobacteriaceae Rapid Test Kit</deviceName>
    <manufacturerName>Beijing Diagreat Biotechnologies Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000019511</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105011799</emdnCode>
    <emdnDescription>BACTERIOLOGY IMMUNOASSAY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>697518250E118062F</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-26T16:27:18.627Z</lastUpdated>
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  <row>
    <udiDi>06936155804580</udiDi>
    <basicUdiDi>B-06936155804580</basicUdiDi>
    <tradeName>Rapid Anti-TB (Mycobacterium Tuberculosis) Test</tradeName>
    <deviceName></deviceName>
    <manufacturerName>InTec PRODUCTS, INC.</manufacturerName>
    <manufacturerSrn>CN-MF-000023625</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0105011799</emdnCode>
    <emdnDescription>BACTERIOLOGY IMMUNOASSAY - OTHER</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>ITP09002-TC40</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T12:13:30.629Z</lastUpdated>
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  <row>
    <udiDi>04260658551439</udiDi>
    <basicUdiDi>B-04260658551439</basicUdiDi>
    <tradeName>Atlas Brucella Antigen Kit with Controls, (5ml Brucella melitensis, 5ml Brucella abortus, 2x1.0 ml Controls)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Atlas Medical GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000029961</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0105011701</emdnCode>
    <emdnDescription>BRUCELLA</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8.01.15.1.0010</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-18T00:34:31.746Z</lastUpdated>
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    <udiDi>04260658551422</udiDi>
    <basicUdiDi>B-04260658551422</basicUdiDi>
    <tradeName>Atlas Brucella Antigen Kit, (5ml Brucella Melitensis, 5ml Brucella Abortus)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Atlas Medical GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000029961</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0105011701</emdnCode>
    <emdnDescription>BRUCELLA</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8.01.15.0.0010</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-18T00:34:30.853Z</lastUpdated>
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    <udiDi>04260658551415</udiDi>
    <basicUdiDi>B-04260658551415</basicUdiDi>
    <tradeName>Atlas Proteus OXK Reagent, 5 ml/vial, 8 vials/Box.</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Atlas Medical GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000029961</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0105011712</emdnCode>
    <emdnDescription>PROTEUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8.01.14.1.0040</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-18T00:34:29.948Z</lastUpdated>
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    <udiDi>04260658551408</udiDi>
    <basicUdiDi>B-04260658551408</basicUdiDi>
    <tradeName>Atlas Proteus OXK Reagent, 5 ml/vial, 1 vial/Box.</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Atlas Medical GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000029961</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0105011712</emdnCode>
    <emdnDescription>PROTEUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8.01.14.0.0005</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-18T00:34:29.046Z</lastUpdated>
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    <udiDi>04260658551392</udiDi>
    <basicUdiDi>B-04260658551392</basicUdiDi>
    <tradeName>Atlas Proteus OX19 Reagent, 5 ml/vial, 8 vials/Box.</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Atlas Medical GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000029961</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0105011712</emdnCode>
    <emdnDescription>PROTEUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8.01.13.1.0040</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-18T00:34:28.148Z</lastUpdated>
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  <row>
    <udiDi>04260658551385</udiDi>
    <basicUdiDi>B-04260658551385</basicUdiDi>
    <tradeName>Atlas Proteus OX19 Reagent, 5 ml/vial, 1 vial/Box.</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Atlas Medical GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000029961</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0105011712</emdnCode>
    <emdnDescription>PROTEUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8.01.13.0.0005</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-18T00:34:27.245Z</lastUpdated>
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