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    <basicUdiDi>4987869ICMV2cfDNA12gCZV</basicUdiDi>
    <tradeName>MagDEA Dx MV Ⅱ cfDNA (12gC)</tradeName>
    <deviceName>MagDEA Dx MV Ⅱ cfDNA (12gC)</deviceName>
    <manufacturerName>Precision System Science Co., Ltd.</manufacturerName>
    <manufacturerSrn>JP-MF-000029061</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>ROBOTIC SAMPLE PROCESSING SYSTEMS - IVD MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>I8312</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:10:53.524Z</lastUpdated>
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    <udiDi>04987869982127</udiDi>
    <basicUdiDi>4987869ICMV212gCV5</basicUdiDi>
    <tradeName>MagDEA Dx MV Ⅱ (12gC)</tradeName>
    <deviceName>MagDEA Dx MV Ⅱ (12gC)</deviceName>
    <manufacturerName>Precision System Science Co., Ltd.</manufacturerName>
    <manufacturerSrn>JP-MF-000029061</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>ROBOTIC SAMPLE PROCESSING SYSTEMS - IVD MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>I8212</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:10:52.726Z</lastUpdated>
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    <udiDi>04987869978120</udiDi>
    <basicUdiDi>4987869ICSV40012gCRJ</basicUdiDi>
    <tradeName>MagDEA Dx SV 400 12gC</tradeName>
    <deviceName>MagDEA Dx SV 400 12gC</deviceName>
    <manufacturerName>Precision System Science Co., Ltd.</manufacturerName>
    <manufacturerSrn>JP-MF-000029061</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>ROBOTIC SAMPLE PROCESSING SYSTEMS - IVD MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>I7812</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:10:51.920Z</lastUpdated>
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    <udiDi>04987869977123</udiDi>
    <basicUdiDi>4987869ICSV20012gCQG</basicUdiDi>
    <tradeName>MagDEA Dx SV 200 12gC</tradeName>
    <deviceName>MagDEA Dx SV 200 12gC</deviceName>
    <manufacturerName>Precision System Science Co., Ltd.</manufacturerName>
    <manufacturerSrn>JP-MF-000029061</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>ROBOTIC SAMPLE PROCESSING SYSTEMS - IVD MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>I7712</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:10:51.113Z</lastUpdated>
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    <udiDi>04987869689002</udiDi>
    <basicUdiDi>4987869gLConsumableG8</basicUdiDi>
    <tradeName>geneLEAD VIII Consumable Set</tradeName>
    <deviceName>geneLEAD VIII Consumable Set</deviceName>
    <manufacturerName>Precision System Science Co., Ltd.</manufacturerName>
    <manufacturerSrn>JP-MF-000029061</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>PIPETTE TIPS WITH FILTER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>F8900</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:10:50.329Z</lastUpdated>
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    <udiDi>04987869688401</udiDi>
    <basicUdiDi>4987869gLRreactionP5</basicUdiDi>
    <tradeName>geneLEAD VIII PCR Reaction Cassette Set</tradeName>
    <deviceName>geneLEAD VIII PCR Reaction Cassette Set</deviceName>
    <manufacturerName>Precision System Science Co., Ltd.</manufacturerName>
    <manufacturerSrn>JP-MF-000029061</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>SAMPLES ANALYSES, PLASTIC MICROTUBES WITHOUT ADDITIVES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>F8840</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:10:49.516Z</lastUpdated>
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    <udiDi>04987869688203</udiDi>
    <basicUdiDi>4987869gLReagentWD</basicUdiDi>
    <tradeName>geneLEAD VIII PCR Reagent Cassette Set</tradeName>
    <deviceName>geneLEAD VIII PCR Reagent Cassette Set</deviceName>
    <manufacturerName>Precision System Science Co., Ltd.</manufacturerName>
    <manufacturerSrn>JP-MF-000029061</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>SAMPLES ANALYSES, PLASTIC MICROTUBES WITHOUT ADDITIVES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>F8820</reference>
    <placedOnMarketCountry>Luxembourg</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:10:48.717Z</lastUpdated>
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    <udiDi>04987869644605</udiDi>
    <basicUdiDi>4987869ConsumableT3</basicUdiDi>
    <tradeName>Micro tube 1.5mL(200pcs)</tradeName>
    <deviceName>Micro tube 1.5mL(200pcs)</deviceName>
    <manufacturerName>Precision System Science Co., Ltd.</manufacturerName>
    <manufacturerSrn>JP-MF-000029061</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>IVD GENERAL USE CONSUMABLES DEVICES - OTHER ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>F4460</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:10:47.932Z</lastUpdated>
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    <udiDi>04987869644308</udiDi>
    <basicUdiDi>4987869mLConsumableP6</basicUdiDi>
    <tradeName>magLEAD Consumable kit</tradeName>
    <deviceName>magLEAD Consumable kit</deviceName>
    <manufacturerName>Precision System Science Co., Ltd.</manufacturerName>
    <manufacturerSrn>JP-MF-000029061</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>PIPETTE TIPS WITH FILTER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>F4430</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:10:47.139Z</lastUpdated>
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    <udiDi>04987869621255</udiDi>
    <basicUdiDi>4987869WasteBoxHZ</basicUdiDi>
    <tradeName>geneLEAD Waste Box</tradeName>
    <deviceName>geneLEAD Waste Box</deviceName>
    <manufacturerName>Precision System Science Co., Ltd.</manufacturerName>
    <manufacturerSrn>JP-MF-000029061</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>IVD GENERAL USE CONSUMABLES DEVICES - OTHER ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>F2125</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:10:46.337Z</lastUpdated>
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    <udiDi>04987869513239</udiDi>
    <basicUdiDi>4987869MagDEAMVDQ</basicUdiDi>
    <tradeName>MagDEA Dx MV Ⅱ</tradeName>
    <deviceName>MagDEA Dx MV Ⅱ</deviceName>
    <manufacturerName>Precision System Science Co., Ltd.</manufacturerName>
    <manufacturerSrn>JP-MF-000029061</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>E1323</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:10:45.534Z</lastUpdated>
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    <udiDi>04987869513000</udiDi>
    <basicUdiDi>4987869MagDEARM</basicUdiDi>
    <tradeName>MagDEA Dx SV</tradeName>
    <deviceName>MagDEA Dx SV</deviceName>
    <manufacturerName>Precision System Science Co., Ltd.</manufacturerName>
    <manufacturerSrn>JP-MF-000029061</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>E1300</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:10:44.718Z</lastUpdated>
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    <udiDi>04987869127009</udiDi>
    <basicUdiDi>4987869geneLEAD8S</basicUdiDi>
    <tradeName>geneLEAD VIII</tradeName>
    <deviceName>geneLEAD VIII</deviceName>
    <manufacturerName>Precision System Science Co., Ltd.</manufacturerName>
    <manufacturerSrn>JP-MF-000029061</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A2700</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:10:43.944Z</lastUpdated>
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    <udiDi>04987869122400</udiDi>
    <basicUdiDi>4987869geneLEAD24UE</basicUdiDi>
    <tradeName>geneLEAD XXIV</tradeName>
    <deviceName>geneLEAD XXIV</deviceName>
    <manufacturerName>Precision System Science Co., Ltd.</manufacturerName>
    <manufacturerSrn>JP-MF-000029061</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A2240</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:10:43.119Z</lastUpdated>
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    <udiDi>04987869111404</udiDi>
    <basicUdiDi>4987869magLEAD4gCFK</basicUdiDi>
    <tradeName>magLEAD 4gC</tradeName>
    <deviceName>magLEAD 4gC</deviceName>
    <manufacturerName>Precision System Science Co., Ltd.</manufacturerName>
    <manufacturerSrn>JP-MF-000029061</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>DNA GENOMIC PREPARATION DEVICES</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>A1140</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:10:42.344Z</lastUpdated>
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    <udiDi>04987869111329</udiDi>
    <basicUdiDi>4987869magLEAD12gCLiNKKM</basicUdiDi>
    <tradeName>magLEAD 12gC LiNK(Abalat)</tradeName>
    <deviceName>magLEAD 12gC LiNK</deviceName>
    <manufacturerName>Precision System Science Co., Ltd.</manufacturerName>
    <manufacturerSrn>JP-MF-000029061</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>DNA GENOMIC PREPARATION DEVICES</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>A1132</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:10:41.538Z</lastUpdated>
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    <udiDi>04987869111206</udiDi>
    <basicUdiDi>4987869magLEADHX</basicUdiDi>
    <tradeName>magLEAD 12gC</tradeName>
    <deviceName>magLEAD 12gC</deviceName>
    <manufacturerName>Precision System Science Co., Ltd.</manufacturerName>
    <manufacturerSrn>JP-MF-000029061</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>DNA GENOMIC PREPARATION DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A1120</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:10:40.719Z</lastUpdated>
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