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    <deviceName>17α-hydroxyprogesterone (17α-OHP) ELISA</deviceName>
    <manufacturerName>Diagnostics Biochem Canada Inc.</manufacturerName>
    <manufacturerSrn>CA-MF-000032449</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>CAN-P-320</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-31T22:40:43.061Z</lastUpdated>
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    <udiDi>++B261CANP400FJ</udiDi>
    <basicUdiDi>B-++B261CANP400FJ</basicUdiDi>
    <tradeName>++B261CANP400FJ</tradeName>
    <deviceName>17α-hydroxyprogesterone (17α-OHP) ELISA</deviceName>
    <manufacturerName>Diagnostics Biochem Canada Inc.</manufacturerName>
    <manufacturerSrn>CA-MF-000032449</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
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    <legislation>IVDD</legislation>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>CAN-P-400</reference>
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    <udiDi>06942359543668</udiDi>
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    <tradeName>17α-OHP CLIA Microparticles</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Autobio Diagnostics Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000003348</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
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    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102050107</emdnCode>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>CMF0903</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
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    <udiDi>06925912718048</udiDi>
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    <tradeName>iFlash-17α-OH-P</tradeName>
    <deviceName>iFlash-17α-OH-P</deviceName>
    <manufacturerName>SHENZHEN YHLO BIOTECH CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000001137</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
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    <emdnDescription>17 OH PROGESTERONE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C86061</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T15:31:37.175Z</lastUpdated>
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    <udiDi>05060169690738</udiDi>
    <basicUdiDi>5060169690738XP</basicUdiDi>
    <tradeName>IDS-iSYS 17-OH Progesterone</tradeName>
    <deviceName>IDS-iSYS 17-OH Progesterone</deviceName>
    <manufacturerName>Immunodiagnostic Systems Limited</manufacturerName>
    <manufacturerSrn>GB-MF-000015851</manufacturerSrn>
    <authorisedRepresentativeName>Immunodiagnostic Systems SA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000015342</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102050107</emdnCode>
    <emdnDescription>17 OH PROGESTERONE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IS-5100</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-31T05:32:41.880Z</lastUpdated>
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    <udiDi>15099590214715</udiDi>
    <basicUdiDi>150995905IM14525M</basicUdiDi>
    <tradeName>RIA 17α-Hydroxyprogesterone</tradeName>
    <deviceName>RIA 17α-Hydroxyprogesterone</deviceName>
    <manufacturerName>IMMUNOTECH s.r.o.</manufacturerName>
    <manufacturerSrn>CZ-MF-000001761</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102050107</emdnCode>
    <emdnDescription>17 OH PROGESTERONE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IM1452</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-30T17:43:47.139Z</lastUpdated>
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    <udiDi>D-A072D8</udiDi>
    <basicUdiDi>B-A072D8</basicUdiDi>
    <tradeName>D-A072D8</tradeName>
    <deviceName>INDICAID® FSH Rapid Test</deviceName>
    <manufacturerName>Phase Scientific International Limited</manufacturerName>
    <manufacturerSrn>HK-MF-000025791</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102050107</emdnCode>
    <emdnDescription>17 OH PROGESTERONE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>INDICAID® FSH Rapid Test</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:43:32.817Z</lastUpdated>
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    <udiDi>D-A034CY</udiDi>
    <basicUdiDi>B-A034CY</basicUdiDi>
    <tradeName>INDICAID™ FSH Rapid Test</tradeName>
    <deviceName>INDICAID™ FSH Rapid Test</deviceName>
    <manufacturerName>Phase Scientific International Limited</manufacturerName>
    <manufacturerSrn>HK-MF-000025791</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102050107</emdnCode>
    <emdnDescription>17 OH PROGESTERONE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>INDICAID™ FSH Rapid Test</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:41:45.554Z</lastUpdated>
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    <udiDi>+ENTIDNOV00405</udiDi>
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    <tradeName>+ENTIDNOV00405</tradeName>
    <deviceName>17-OH Progesterone</deviceName>
    <manufacturerName>Gold Standard Diagnostics Frankfurt GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000025020</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102050107</emdnCode>
    <emdnDescription>17 OH PROGESTERONE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DNOV004</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T10:11:40.285Z</lastUpdated>
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    <udiDi>06978139075678</udiDi>
    <basicUdiDi>69703416803205116JF</basicUdiDi>
    <tradeName>17 α-OHP (eCLIA)</tradeName>
    <deviceName>17 α-OHP (eCLIA)</deviceName>
    <manufacturerName>Shenzhen Lifotronic Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005654</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>W0102050107</emdnCode>
    <emdnDescription>17 OH PROGESTERONE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0320514604</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T08:04:03.874Z</lastUpdated>
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    <udiDi>D-K00192WD</udiDi>
    <basicUdiDi>B-K00192WD</basicUdiDi>
    <tradeName>D-K00192WD</tradeName>
    <deviceName>17-a-OH Progesterone</deviceName>
    <manufacturerName>DIALAB Produktion und Vertrieb von chemisch-technischen Produkten und Laborinstrumenten Gesellschaft m.b.H.</manufacturerName>
    <manufacturerSrn>AT-MF-000000254</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102050107</emdnCode>
    <emdnDescription>17 OH PROGESTERONE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>K00192</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-14T00:35:32.269Z</lastUpdated>
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    <udiDi>D-DC76519G9</udiDi>
    <basicUdiDi>B-DC76519G9</basicUdiDi>
    <tradeName>iStar-17α-OH-P</tradeName>
    <deviceName>iStar-17α-OH-P</deviceName>
    <manufacturerName>Shenzhen Drawray Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008763</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102050107</emdnCode>
    <emdnDescription>17 OH PROGESTERONE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DC76519</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T13:16:34.121Z</lastUpdated>
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    <udiDi>D-DC76518G7</udiDi>
    <basicUdiDi>B-DC76518G7</basicUdiDi>
    <tradeName>iStar-17α-OH-P</tradeName>
    <deviceName>iStar-17α-OH-P</deviceName>
    <manufacturerName>Shenzhen Drawray Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008763</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102050107</emdnCode>
    <emdnDescription>17 OH PROGESTERONE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DC76518</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T13:16:33.246Z</lastUpdated>
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    <udiDi>D-DC76517G5</udiDi>
    <basicUdiDi>B-DC76517G5</basicUdiDi>
    <tradeName>iStar-17α-OH-P</tradeName>
    <deviceName>iStar-17α-OH-P</deviceName>
    <manufacturerName>Shenzhen Drawray Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008763</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102050107</emdnCode>
    <emdnDescription>17 OH PROGESTERONE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DC76517</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T13:16:31.664Z</lastUpdated>
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    <udiDi>D-DC76516G3</udiDi>
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    <tradeName>iStar-17α-OH-P</tradeName>
    <deviceName>iStar-17α-OH-P</deviceName>
    <manufacturerName>Shenzhen Drawray Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008763</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102050107</emdnCode>
    <emdnDescription>17 OH PROGESTERONE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DC76516</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-13T13:16:29.269Z</lastUpdated>
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    <udiDi>06978139075715</udiDi>
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    <tradeName>17 α-OHP (eCLIA)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Lifotronic Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005654</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>W0102050107</emdnCode>
    <emdnDescription>17 OH PROGESTERONE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0320514601</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:10:31.415Z</lastUpdated>
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    <udiDi>06978139075708</udiDi>
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    <tradeName>17 α-OHP (eCLIA)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Lifotronic Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005654</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>W0102050107</emdnCode>
    <emdnDescription>17 OH PROGESTERONE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0320514602</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:10:31.059Z</lastUpdated>
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    <udiDi>06978139075692</udiDi>
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    <tradeName>17 α-OHP (eCLIA)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Lifotronic Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005654</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>W0102050107</emdnCode>
    <emdnDescription>17 OH PROGESTERONE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0320514603</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:10:30.598Z</lastUpdated>
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    <udiDi>06925912721130</udiDi>
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    <tradeName>iFlash-17α-OH-P</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SHENZHEN YHLO BIOTECH CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000001137</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102050107</emdnCode>
    <emdnDescription>17 OH PROGESTERONE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C86061-S</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-11T10:48:11.366Z</lastUpdated>
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    <basicUdiDi>697015090000034GZ</basicUdiDi>
    <tradeName>17α-OHP CLIA Microparticles</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Autobio Diagnostics Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000003348</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102050107</emdnCode>
    <emdnDescription>17 OH PROGESTERONE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CMF0905</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-08T16:47:20.122Z</lastUpdated>
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