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    <tradeName>06975090500300</tradeName>
    <deviceName>Human Chorionic Gonadotropin (EECL)</deviceName>
    <manufacturerName>Accucise Diagnostics Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000045017</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102050205</emdnCode>
    <emdnDescription>TOTAL HUMAN CHORIONIC GONADOTROPIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1030101000</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T18:53:12.094Z</lastUpdated>
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    <udiDi>06975070768911</udiDi>
    <basicUdiDi>B-06975070768911</basicUdiDi>
    <tradeName>Sharay Inhibin B (CLIA)</tradeName>
    <deviceName>Sharay Inhibin B (CLIA)</deviceName>
    <manufacturerName>C-Luminary Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000035089</manufacturerSrn>
    <authorisedRepresentativeName>Sungo Cert GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000010869</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102050214</emdnCode>
    <emdnDescription>INHIBIN A/B (PRENATAL SCREENING)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T18:49:49.473Z</lastUpdated>
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    <udiDi>06975070766191</udiDi>
    <basicUdiDi>B-06975070766191</basicUdiDi>
    <tradeName>Sharay Inhibin B (CLIA)</tradeName>
    <deviceName>Sharay Inhibin B (CLIA)</deviceName>
    <manufacturerName>C-Luminary Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000035089</manufacturerSrn>
    <authorisedRepresentativeName>Sungo Cert GmbH</authorisedRepresentativeName>
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    <legislation>IVDD</legislation>
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    <emdnDescription>INHIBIN A/B (PRENATAL SCREENING)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T18:43:11.942Z</lastUpdated>
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    <udiDi>06975070762988</udiDi>
    <basicUdiDi>B-06975070762988</basicUdiDi>
    <tradeName>Sharay free-β-HCG (CLIA)</tradeName>
    <deviceName>Sharay free-β-HCG (CLIA)</deviceName>
    <manufacturerName>C-Luminary Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000035089</manufacturerSrn>
    <authorisedRepresentativeName>Sungo Cert GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000010869</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102050206</emdnCode>
    <emdnDescription>B- HUMAN CHORIONIC GONADOTROPIN (INCL. SUBUNIT)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>18717001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T18:40:06.045Z</lastUpdated>
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    <udiDi>06975070762971</udiDi>
    <basicUdiDi>B-06975070762971</basicUdiDi>
    <tradeName>Sharay PAPP-A (CLIA)</tradeName>
    <deviceName>Sharay PAPP-A (CLIA)</deviceName>
    <manufacturerName>C-Luminary Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000035089</manufacturerSrn>
    <authorisedRepresentativeName>Sungo Cert GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000010869</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102050210</emdnCode>
    <emdnDescription>PREGNANCY ASSOCIATED PLASMA PROTEIN - A (DOWNS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>18716001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T18:40:05.251Z</lastUpdated>
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    <udiDi>06975070762964</udiDi>
    <basicUdiDi>B-06975070762964</basicUdiDi>
    <tradeName>Sharay uE3 (CLIA)</tradeName>
    <deviceName>Sharay uE3 (CLIA)</deviceName>
    <manufacturerName>C-Luminary Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000035089</manufacturerSrn>
    <authorisedRepresentativeName>Sungo Cert GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000010869</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102050203</emdnCode>
    <emdnDescription>UNCONJUGATED (FREE) ESTRIOL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>18715001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T18:40:03.645Z</lastUpdated>
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    <udiDi>06975070762940</udiDi>
    <basicUdiDi>B-06975070762940</basicUdiDi>
    <tradeName>Sharay β-HCG (CLIA)</tradeName>
    <deviceName>Sharay β-HCG (CLIA)</deviceName>
    <manufacturerName>C-Luminary Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000035089</manufacturerSrn>
    <authorisedRepresentativeName>Sungo Cert GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000010869</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102050205</emdnCode>
    <emdnDescription>TOTAL HUMAN CHORIONIC GONADOTROPIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>18711001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T18:39:59.651Z</lastUpdated>
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    <udiDi>06975070762407</udiDi>
    <basicUdiDi>B-06975070762407</basicUdiDi>
    <tradeName>Sharay AMH (CLIA)</tradeName>
    <deviceName>Sharay AMH (CLIA)</deviceName>
    <manufacturerName>C-Luminary Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000035089</manufacturerSrn>
    <authorisedRepresentativeName>Sungo Cert GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000010869</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102050215</emdnCode>
    <emdnDescription>ANTI-MÛLLERIAN HORMONE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>14000896</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T18:38:08.269Z</lastUpdated>
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    <udiDi>06975070761950</udiDi>
    <basicUdiDi>B-06975070761950</basicUdiDi>
    <tradeName>Sharay AMH (CLIA)</tradeName>
    <deviceName>Sharay AMH (CLIA)</deviceName>
    <manufacturerName>C-Luminary Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000035089</manufacturerSrn>
    <authorisedRepresentativeName>Sungo Cert GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000010869</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102050215</emdnCode>
    <emdnDescription>ANTI-MÛLLERIAN HORMONE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>18401001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T18:36:54.288Z</lastUpdated>
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    <udiDi>06975068490657</udiDi>
    <basicUdiDi>B-06975068490657</basicUdiDi>
    <tradeName>Beta-Human Chorionic Gonadotropin（Beta-HCG）Rapid Quantitative Test（Fluorescence Immunoassay）</tradeName>
    <deviceName>Beta-Human Chorionic Gonadotropin（Beta-HCG）Rapid Quantitative Test（Fluorescence Immunoassay）</deviceName>
    <manufacturerName>WWHS Biotech.Inc</manufacturerName>
    <manufacturerSrn>CN-MF-000027179</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102050206</emdnCode>
    <emdnDescription>B- HUMAN CHORIONIC GONADOTROPIN (INCL. SUBUNIT)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CP061.B1</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-06T18:31:32.513Z</lastUpdated>
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    <udiDi>06974986814972</udiDi>
    <basicUdiDi>B-06974986814972</basicUdiDi>
    <tradeName>Beta-Human Chorionic Gonadotropin (Beta-HCG) Assay Kit (Chemiluminescent Immunoassay)</tradeName>
    <deviceName>Beta-Human Chorionic Gonadotropin (Beta-HCG) Assay Kit (Chemiluminescent Immunoassay)</deviceName>
    <manufacturerName>Wuhan Life Origin Biotech Joint Stock Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000027340</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102050206</emdnCode>
    <emdnDescription>B- HUMAN CHORIONIC GONADOTROPIN (INCL. SUBUNIT)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>100 Tests/Kit</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T18:26:43.180Z</lastUpdated>
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    <udiDi>06974986814965</udiDi>
    <basicUdiDi>B-06974986814965</basicUdiDi>
    <tradeName>Beta-Human Chorionic Gonadotropin (Beta-HCG) Assay Kit (Chemiluminescent Immunoassay)</tradeName>
    <deviceName>Beta-Human Chorionic Gonadotropin (Beta-HCG) Assay Kit (Chemiluminescent Immunoassay)</deviceName>
    <manufacturerName>Wuhan Life Origin Biotech Joint Stock Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000027340</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102050206</emdnCode>
    <emdnDescription>B- HUMAN CHORIONIC GONADOTROPIN (INCL. SUBUNIT)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>50 Tests/Kit</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T18:26:42.363Z</lastUpdated>
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    <udiDi>06974986814958</udiDi>
    <basicUdiDi>B-06974986814958</basicUdiDi>
    <tradeName>Beta-Human Chorionic Gonadotropin (Beta-HCG) Assay Kit (Chemiluminescent Immunoassay)</tradeName>
    <deviceName>Beta-Human Chorionic Gonadotropin (Beta-HCG) Assay Kit (Chemiluminescent Immunoassay)</deviceName>
    <manufacturerName>Wuhan Life Origin Biotech Joint Stock Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000027340</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102050206</emdnCode>
    <emdnDescription>B- HUMAN CHORIONIC GONADOTROPIN (INCL. SUBUNIT)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>25 Tests/Kit</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T18:26:41.555Z</lastUpdated>
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    <udiDi>06974986814767</udiDi>
    <basicUdiDi>B-06974986814767</basicUdiDi>
    <tradeName>Anti-Mullerian Hormone (AMH) Assay Kit (Chemiluminescent Immunoassay)</tradeName>
    <deviceName>Anti-Mullerian Hormone (AMH) Assay Kit (Chemiluminescent Immunoassay)</deviceName>
    <manufacturerName>Wuhan Life Origin Biotech Joint Stock Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000027340</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102050215</emdnCode>
    <emdnDescription>ANTI-MÛLLERIAN HORMONE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>100 Tests/Kit</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T18:24:22.007Z</lastUpdated>
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    <basicUdiDi>B-06974986814750</basicUdiDi>
    <tradeName>Anti-Mullerian Hormone (AMH) Assay Kit (Chemiluminescent Immunoassay)</tradeName>
    <deviceName>Anti-Mullerian Hormone (AMH) Assay Kit (Chemiluminescent Immunoassay)</deviceName>
    <manufacturerName>Wuhan Life Origin Biotech Joint Stock Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000027340</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102050215</emdnCode>
    <emdnDescription>ANTI-MÛLLERIAN HORMONE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>50 Tests/Kit</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T18:24:21.213Z</lastUpdated>
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    <udiDi>06974986814743</udiDi>
    <basicUdiDi>B-06974986814743</basicUdiDi>
    <tradeName>Anti-Mullerian Hormone (AMH) Assay Kit (Chemiluminescent Immunoassay)</tradeName>
    <deviceName>Anti-Mullerian Hormone (AMH) Assay Kit (Chemiluminescent Immunoassay)</deviceName>
    <manufacturerName>Wuhan Life Origin Biotech Joint Stock Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000027340</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102050215</emdnCode>
    <emdnDescription>ANTI-MÛLLERIAN HORMONE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>25 Tests/Kit</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T18:24:20.408Z</lastUpdated>
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    <basicUdiDi>B-06974986814187</basicUdiDi>
    <tradeName>Anti-Mullerian hormone Assay Kit (Immunochromatographic Assay)</tradeName>
    <deviceName>Anti-Mullerian hormone Assay Kit (Immunochromatographic Assay)</deviceName>
    <manufacturerName>Wuhan Life Origin Biotech Joint Stock Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000027340</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102050215</emdnCode>
    <emdnDescription>ANTI-MÛLLERIAN HORMONE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>100 tests/kit</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T18:22:25.034Z</lastUpdated>
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    <basicUdiDi>B-06974986814170</basicUdiDi>
    <tradeName>Anti-Mullerian hormone Assay Kit (Immunochromatographic Assay)</tradeName>
    <deviceName>Anti-Mullerian hormone Assay Kit (Immunochromatographic Assay)</deviceName>
    <manufacturerName>Wuhan Life Origin Biotech Joint Stock Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000027340</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102050215</emdnCode>
    <emdnDescription>ANTI-MÛLLERIAN HORMONE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>50 tests/kit</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T18:22:21.043Z</lastUpdated>
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    <basicUdiDi>B-06974986814163</basicUdiDi>
    <tradeName>Anti-Mullerian hormone Assay Kit (Immunochromatographic Assay)</tradeName>
    <deviceName>Anti-Mullerian hormone Assay Kit (Immunochromatographic Assay)</deviceName>
    <manufacturerName>Wuhan Life Origin Biotech Joint Stock Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000027340</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102050215</emdnCode>
    <emdnDescription>ANTI-MÛLLERIAN HORMONE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>25 tests/kit</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T18:22:20.242Z</lastUpdated>
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    <basicUdiDi>B-06974986814156</basicUdiDi>
    <tradeName>Anti-Mullerian hormone Assay Kit (Immunochromatographic Assay)</tradeName>
    <deviceName>Anti-Mullerian hormone Assay Kit (Immunochromatographic Assay)</deviceName>
    <manufacturerName>Wuhan Life Origin Biotech Joint Stock Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000027340</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102050215</emdnCode>
    <emdnDescription>ANTI-MÛLLERIAN HORMONE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10 tests/kit</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T18:22:19.435Z</lastUpdated>
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