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    <basicUdiDi>4987562RDSampleVial3J</basicUdiDi>
    <tradeName>04987562499250</tradeName>
    <deviceName>RD Sample Vial</deviceName>
    <manufacturerName>SYSMEX CORPORATION</manufacturerName>
    <manufacturerSrn>JP-MF-000014037</manufacturerSrn>
    <authorisedRepresentativeName>Sysmex Europe SE</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000022333</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0503020180</emdnCode>
    <emdnDescription>PIPETTES - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BP-675-300</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T04:35:56.281Z</lastUpdated>
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    <udiDi>04987562460427</udiDi>
    <basicUdiDi>4987562CELLCLEANU9X</basicUdiDi>
    <tradeName>CELLCLEAN U</tradeName>
    <deviceName>CELLCLEAN U</deviceName>
    <manufacturerName>SYSMEX CORPORATION</manufacturerName>
    <manufacturerSrn>JP-MF-000014037</manufacturerSrn>
    <authorisedRepresentativeName>Sysmex Europe SE</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000022333</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0599</emdnCode>
    <emdnDescription>IVD GENERAL USE CONSUMABLE DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CM-942-712</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T04:35:46.953Z</lastUpdated>
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    <udiDi>04987562418664</udiDi>
    <basicUdiDi>4987562SBCuvetteB5</basicUdiDi>
    <tradeName>04987562418664</tradeName>
    <deviceName>SB Cuvette</deviceName>
    <manufacturerName>SYSMEX CORPORATION</manufacturerName>
    <manufacturerSrn>JP-MF-000014037</manufacturerSrn>
    <authorisedRepresentativeName>Sysmex Europe SE</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000022333</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0503010203</emdnCode>
    <emdnDescription>SAMPLES ANALYSES, PLASTIC CUVETTES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>06410419</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T04:34:59.098Z</lastUpdated>
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    <udiDi>04987562408269</udiDi>
    <basicUdiDi>4987562LYC-400A5E</basicUdiDi>
    <tradeName>04987562408269</tradeName>
    <deviceName>Detection Cell</deviceName>
    <manufacturerName>SYSMEX CORPORATION</manufacturerName>
    <manufacturerSrn>JP-MF-000014037</manufacturerSrn>
    <authorisedRepresentativeName>Sysmex Europe SE</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000022333</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0503040199</emdnCode>
    <emdnDescription>CELL AND TISSUE CULTURES, CONTAINERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>054-3781-8</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T04:34:52.474Z</lastUpdated>
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    <udiDi>04987486039129</udiDi>
    <basicUdiDi>4987486BC0108243GS</basicUdiDi>
    <tradeName>Centrifuge Tube (for SPOTCHEM EZ)</tradeName>
    <deviceName>Centrifuge Tube (for SPOTCHEM EZ)</deviceName>
    <manufacturerName>ARKRAY Factory, Inc.</manufacturerName>
    <manufacturerSrn>JP-MF-000003008</manufacturerSrn>
    <authorisedRepresentativeName>ARKRAY Europe, B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002056</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W050301029099</emdnCode>
    <emdnDescription>SAMPLES ANALYSES, PLASTIC CONTAINERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>108243</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T04:33:52.386Z</lastUpdated>
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    <udiDi>04987486039105</udiDi>
    <basicUdiDi>4987486BC0108241GN</basicUdiDi>
    <tradeName>Whole Blood Sample Tube</tradeName>
    <deviceName>Whole Blood Sample Tube</deviceName>
    <manufacturerName>ARKRAY Factory, Inc.</manufacturerName>
    <manufacturerSrn>JP-MF-000003008</manufacturerSrn>
    <authorisedRepresentativeName>ARKRAY Europe, B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002056</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W050301029099</emdnCode>
    <emdnDescription>SAMPLES ANALYSES, PLASTIC CONTAINERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>108241</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T04:33:51.581Z</lastUpdated>
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    <udiDi>04987486039099</udiDi>
    <basicUdiDi>4987486BC0108240GL</basicUdiDi>
    <tradeName>Centrifuge Cup (for D-Concept)</tradeName>
    <deviceName>Centrifuge Cup (for D-Concept)</deviceName>
    <manufacturerName>ARKRAY Factory, Inc.</manufacturerName>
    <manufacturerSrn>JP-MF-000003008</manufacturerSrn>
    <authorisedRepresentativeName>ARKRAY Europe, B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002056</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W050301029099</emdnCode>
    <emdnDescription>SAMPLES ANALYSES, PLASTIC CONTAINERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>108240</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T04:33:49.977Z</lastUpdated>
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    <udiDi>04987486039075</udiDi>
    <basicUdiDi>4987486BC0108238GZ</basicUdiDi>
    <tradeName>Cuvette (heparin)</tradeName>
    <deviceName>Cuvette (heparin)</deviceName>
    <manufacturerName>ARKRAY Factory, Inc.</manufacturerName>
    <manufacturerSrn>JP-MF-000003008</manufacturerSrn>
    <authorisedRepresentativeName>ARKRAY Europe, B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002056</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W050301029099</emdnCode>
    <emdnDescription>SAMPLES ANALYSES, PLASTIC CONTAINERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>108238</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T04:33:47.584Z</lastUpdated>
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    <udiDi>04987295636311</udiDi>
    <basicUdiDi>4987295BU003ZV</basicUdiDi>
    <tradeName>EXTEL HEMO・AUTO MC Collection Picker</tradeName>
    <deviceName>EXTEL HEMO・AUTO MC Collection Picker</deviceName>
    <manufacturerName>Canon Medical Diagnostics Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000020364</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W05019001</emdnCode>
    <emdnDescription>FAECES COLLECTION DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>63631</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-31T04:32:36.312Z</lastUpdated>
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    <udiDi>04987274125874</udiDi>
    <basicUdiDi>4987274W0580WSA00G9</basicUdiDi>
    <tradeName>Wash Solution A</tradeName>
    <deviceName>Wash Solution A</deviceName>
    <manufacturerName>Alfresa Pharma Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000008778</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0580</emdnCode>
    <emdnDescription>IVD GENERAL USE CONSUMABLES DEVICES - OTHER ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>912587</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-31T04:32:01.496Z</lastUpdated>
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    <udiDi>04987274058608</udiDi>
    <basicUdiDi>4987274W05019001SCC007Z</basicUdiDi>
    <tradeName>Specimen Collection Container A</tradeName>
    <deviceName>Specimen Collection Container A</deviceName>
    <manufacturerName>Alfresa Pharma Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000008778</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W05019001</emdnCode>
    <emdnDescription>FAECES COLLECTION DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>905860</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-31T04:31:53.131Z</lastUpdated>
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    <udiDi>04987026212289</udiDi>
    <basicUdiDi>4987026TD-OCLBYU</basicUdiDi>
    <tradeName>OC-Light™ S FIT Sampling Bottles</tradeName>
    <deviceName></deviceName>
    <manufacturerName>EIKEN CHEMICAL CO., LTD.</manufacturerName>
    <manufacturerSrn>JP-MF-000018097</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W05019001</emdnCode>
    <emdnDescription>FAECES COLLECTION DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>V-PH82</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-31T04:31:42.024Z</lastUpdated>
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    <udiDi>04987026130088</udiDi>
    <basicUdiDi>4987026TD-OCSBZH</basicUdiDi>
    <tradeName>OC-Auto Sampling Bottle 3 (VCPZ25)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>EIKEN CHEMICAL CO., LTD.</manufacturerName>
    <manufacturerSrn>JP-MF-000018097</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W05019001</emdnCode>
    <emdnDescription>FAECES COLLECTION DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>V-PZ25</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-31T04:31:38.732Z</lastUpdated>
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    <udiDi>04980679161515</udiDi>
    <basicUdiDi>498067916151L8</basicUdiDi>
    <tradeName>04980679161515</tradeName>
    <deviceName>Wash solution</deviceName>
    <manufacturerName>JOKOH CO.,LTD.</manufacturerName>
    <manufacturerSrn>JP-MF-000025161</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0580</emdnCode>
    <emdnDescription>IVD GENERAL USE CONSUMABLES DEVICES - OTHER ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>J16151</reference>
    <placedOnMarketCountry>Lithuania</placedOnMarketCountry>
    <lastUpdated>2026-07-31T04:31:33.137Z</lastUpdated>
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    <udiDi>04980679064656</udiDi>
    <basicUdiDi>498067906465LP</basicUdiDi>
    <tradeName>04980679064656</tradeName>
    <deviceName>Smart Sed</deviceName>
    <manufacturerName>JOKOH CO.,LTD.</manufacturerName>
    <manufacturerSrn>JP-MF-000025161</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W050101010201</emdnCode>
    <emdnDescription>BLOOD COLLECTION, TUBES WITH ADDITIVES OR SERUM SEPARATOR</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>J06465</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-07-31T04:31:27.613Z</lastUpdated>
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    <udiDi>04946247463252</udiDi>
    <basicUdiDi>49462474MVG19SW</basicUdiDi>
    <tradeName>MV Glass LBC Adhesive Glass Slide</tradeName>
    <deviceName>Microscope Slide</deviceName>
    <manufacturerName>Matsunami Glass Ind., Ltd.</manufacturerName>
    <manufacturerSrn>JP-MF-000023949</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0503900201</emdnCode>
    <emdnDescription>MICROSCOPE SLIDES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MV-1190</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T04:23:37.396Z</lastUpdated>
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    <udiDi>04779054721365</udiDi>
    <basicUdiDi>477905472RS26015KR</basicUdiDi>
    <tradeName>IVD Sample Collection Kit</tradeName>
    <deviceName>IVD Sample Collection Kit</deviceName>
    <manufacturerName>RDA Spot, UAB</manufacturerName>
    <manufacturerSrn>LT-MF-000027300</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0501010299</emdnCode>
    <emdnDescription>CAPILLARY BLOOD COLLECTION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RS26015</reference>
    <placedOnMarketCountry>Lithuania</placedOnMarketCountry>
    <lastUpdated>2026-07-31T04:08:03.205Z</lastUpdated>
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    <udiDi>04779054721334</udiDi>
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    <tradeName>IVD Sample Collection Kit</tradeName>
    <deviceName>IVD Sample Collection Kit</deviceName>
    <manufacturerName>RDA Spot, UAB</manufacturerName>
    <manufacturerSrn>LT-MF-000027300</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
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    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0501010299</emdnCode>
    <emdnDescription>CAPILLARY BLOOD COLLECTION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RS26012</reference>
    <placedOnMarketCountry>Lithuania</placedOnMarketCountry>
    <lastUpdated>2026-07-31T04:08:02.416Z</lastUpdated>
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    <tradeName>IVD Sample Collection Kit</tradeName>
    <deviceName>IVD Sample Collection Kit</deviceName>
    <manufacturerName>RDA Spot, UAB</manufacturerName>
    <manufacturerSrn>LT-MF-000027300</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0501010199</emdnCode>
    <emdnDescription>VENOUS OR ARTERIOUS BLOOD COLLECTION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RS26005</reference>
    <placedOnMarketCountry>Lithuania</placedOnMarketCountry>
    <lastUpdated>2026-07-31T04:07:58.400Z</lastUpdated>
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    <udiDi>04779054721310</udiDi>
    <basicUdiDi>477905472RS26006KQ</basicUdiDi>
    <tradeName>IVD Sample Collection Kit</tradeName>
    <deviceName>IVD Sample Collection Kit</deviceName>
    <manufacturerName>RDA Spot, UAB</manufacturerName>
    <manufacturerSrn>LT-MF-000027300</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0501010199</emdnCode>
    <emdnDescription>VENOUS OR ARTERIOUS BLOOD COLLECTION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RS26006</reference>
    <placedOnMarketCountry>Lithuania</placedOnMarketCountry>
    <lastUpdated>2026-07-31T04:07:57.607Z</lastUpdated>
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