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    <tradeName>GenomEra® C. difficile Control Set</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Abacus Diagnostica Oy</manufacturerName>
    <manufacturerSrn>FI-MF-000024114</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105080808</emdnCode>
    <emdnDescription>ALL INFECTIOUS DISEASES CONTROLS - NAT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CDX-20-561</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-13T00:59:42.436Z</lastUpdated>
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    <udiDi>D-81649002AMTBZK01WRV9</udiDi>
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    <tradeName>D-81649002AMTBZK01WRV9</tradeName>
    <deviceName>MTBC Controls</deviceName>
    <manufacturerName>Healgen Life Science LLC</manufacturerName>
    <manufacturerSrn>US-MF-000043017</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105080808</emdnCode>
    <emdnDescription>ALL INFECTIOUS DISEASES CONTROLS - NAT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AMTBZK01-AHG2E</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-12T07:04:27.193Z</lastUpdated>
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    <udiDi>03760369292023</udiDi>
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    <tradeName>NatQal HAV</tradeName>
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    <manufacturerName>ETABLISSEMENT FRANCAIS DU SANG</manufacturerName>
    <manufacturerSrn>FR-MF-000013221</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
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    <emdnCode>W0105080808</emdnCode>
    <emdnDescription>ALL INFECTIOUS DISEASES CONTROLS - NAT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>247842</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-11T02:58:01.504Z</lastUpdated>
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    <udiDi>03760369292061</udiDi>
    <basicUdiDi>376036929DGV0019K</basicUdiDi>
    <tradeName>NatQal HBV</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ETABLISSEMENT FRANCAIS DU SANG</manufacturerName>
    <manufacturerSrn>FR-MF-000013221</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105080808</emdnCode>
    <emdnDescription>ALL INFECTIOUS DISEASES CONTROLS - NAT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>190016</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-11T02:58:01.414Z</lastUpdated>
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    <udiDi>03760369292085</udiDi>
    <basicUdiDi>376036929DGV0019K</basicUdiDi>
    <tradeName>NatQal HIV</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ETABLISSEMENT FRANCAIS DU SANG</manufacturerName>
    <manufacturerSrn>FR-MF-000013221</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105080808</emdnCode>
    <emdnDescription>ALL INFECTIOUS DISEASES CONTROLS - NAT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>190011</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-11T02:58:01.385Z</lastUpdated>
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    <udiDi>03760369292092</udiDi>
    <basicUdiDi>376036929DGV0019K</basicUdiDi>
    <tradeName>NatQal HIV</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ETABLISSEMENT FRANCAIS DU SANG</manufacturerName>
    <manufacturerSrn>FR-MF-000013221</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105080808</emdnCode>
    <emdnDescription>ALL INFECTIOUS DISEASES CONTROLS - NAT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>190012</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-11T02:58:01.355Z</lastUpdated>
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  <row>
    <udiDi>03760369292146</udiDi>
    <basicUdiDi>376036929DGV0019K</basicUdiDi>
    <tradeName>NatQal HEV</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ETABLISSEMENT FRANCAIS DU SANG</manufacturerName>
    <manufacturerSrn>FR-MF-000013221</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105080808</emdnCode>
    <emdnDescription>ALL INFECTIOUS DISEASES CONTROLS - NAT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>274284</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-11T02:58:01.290Z</lastUpdated>
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  <row>
    <udiDi>09351179004056</udiDi>
    <basicUdiDi>B-09351179004056</basicUdiDi>
    <tradeName>EasyScreen</tradeName>
    <deviceName>EasyScreen® Respiratory PCR Positive Control</deviceName>
    <manufacturerName>Genetic Signatures Ltd</manufacturerName>
    <manufacturerSrn>AU-MF-000030901</manufacturerSrn>
    <authorisedRepresentativeName>mdi Europa GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006218</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105080808</emdnCode>
    <emdnDescription>ALL INFECTIOUS DISEASES CONTROLS - NAT</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>PC-RES-007</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-07-10T20:49:47.247Z</lastUpdated>
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  <row>
    <udiDi>09351179004032</udiDi>
    <basicUdiDi>B-09351179004032</basicUdiDi>
    <tradeName>EasyScreen™</tradeName>
    <deviceName>EasyScreen™ Enteric PCR Positive Control</deviceName>
    <manufacturerName>Genetic Signatures Ltd</manufacturerName>
    <manufacturerSrn>AU-MF-000030901</manufacturerSrn>
    <authorisedRepresentativeName>mdi Europa GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006218</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105080808</emdnCode>
    <emdnDescription>ALL INFECTIOUS DISEASES CONTROLS - NAT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PC-ENT-003</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-10T20:49:43.278Z</lastUpdated>
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  <row>
    <udiDi>03760369292030</udiDi>
    <basicUdiDi>376036929DGV0029M</basicUdiDi>
    <tradeName>NatQal HAV</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ETABLISSEMENT FRANCAIS DU SANG</manufacturerName>
    <manufacturerSrn>FR-MF-000013221</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105080808</emdnCode>
    <emdnDescription>ALL INFECTIOUS DISEASES CONTROLS - NAT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>247841</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-08T19:50:47.968Z</lastUpdated>
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  <row>
    <udiDi>03760369291972</udiDi>
    <basicUdiDi>376036929DGV0029M</basicUdiDi>
    <tradeName>NatQal B19-L</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ETABLISSEMENT FRANCAIS DU SANG</manufacturerName>
    <manufacturerSrn>FR-MF-000013221</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105080808</emdnCode>
    <emdnDescription>ALL INFECTIOUS DISEASES CONTROLS - NAT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>247900</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-08T19:49:22.595Z</lastUpdated>
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    <udiDi>03760369291996</udiDi>
    <basicUdiDi>376036929DGV0029M</basicUdiDi>
    <tradeName>NatQal B19-M</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ETABLISSEMENT FRANCAIS DU SANG</manufacturerName>
    <manufacturerSrn>FR-MF-000013221</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105080808</emdnCode>
    <emdnDescription>ALL INFECTIOUS DISEASES CONTROLS - NAT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>247849</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-08T19:49:12.952Z</lastUpdated>
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  <row>
    <udiDi>03760369292009</udiDi>
    <basicUdiDi>376036929DGV0029M</basicUdiDi>
    <tradeName>NatQal B19-M</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ETABLISSEMENT FRANCAIS DU SANG</manufacturerName>
    <manufacturerSrn>FR-MF-000013221</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105080808</emdnCode>
    <emdnDescription>ALL INFECTIOUS DISEASES CONTROLS - NAT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>247848</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-08T19:49:09.097Z</lastUpdated>
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  <row>
    <udiDi>03760369292153</udiDi>
    <basicUdiDi>376036929DGV0019K</basicUdiDi>
    <tradeName>NatQal HEV</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ETABLISSEMENT FRANCAIS DU SANG</manufacturerName>
    <manufacturerSrn>FR-MF-000013221</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105080808</emdnCode>
    <emdnDescription>ALL INFECTIOUS DISEASES CONTROLS - NAT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>274283</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-08T19:46:12.917Z</lastUpdated>
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    <udiDi>06973315739382</udiDi>
    <basicUdiDi>B-06973315739382</basicUdiDi>
    <tradeName>Quality Control Kit for Logilet STl Panel</tradeName>
    <deviceName>Quality Control Kit for Logilet STl Panel</deviceName>
    <manufacturerName>Nanjing Vazyme Medical Technology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000031032</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105080808</emdnCode>
    <emdnDescription>ALL INFECTIOUS DISEASES CONTROLS - NAT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>QC4021</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T14:03:06.248Z</lastUpdated>
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    <udiDi>06973315739306</udiDi>
    <basicUdiDi>B-06973315739306</basicUdiDi>
    <tradeName>Quality Control Kit for Logilet HPV Panel</tradeName>
    <deviceName>Quality Control Kit for Logilet HPV Panel</deviceName>
    <manufacturerName>Nanjing Vazyme Medical Technology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000031032</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105080808</emdnCode>
    <emdnDescription>ALL INFECTIOUS DISEASES CONTROLS - NAT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>QC4011</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T14:03:03.848Z</lastUpdated>
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    <udiDi>03532670503736</udiDi>
    <basicUdiDi>B-03532670503736</basicUdiDi>
    <tradeName>Control Set for rapid SARS-CoV-2 PCR</tradeName>
    <deviceName>Control set for rapid SARS-CoV-2 PCR</deviceName>
    <manufacturerName>BIOSYNEX</manufacturerName>
    <manufacturerSrn>FR-MF-000014073</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105080808</emdnCode>
    <emdnDescription>ALL INFECTIOUS DISEASES CONTROLS - NAT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6150006</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-05T13:38:48.325Z</lastUpdated>
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    <udiDi>00884883007321</udiDi>
    <basicUdiDi>B-00884883007321</basicUdiDi>
    <tradeName>00884883007321</tradeName>
    <deviceName>AcroMetrix Blue</deviceName>
    <manufacturerName>Microgenics Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000030375</manufacturerSrn>
    <authorisedRepresentativeName>B·R·A·H·M·S GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000026031</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105080808</emdnCode>
    <emdnDescription>ALL INFECTIOUS DISEASES CONTROLS - NAT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>969032</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T09:24:43.575Z</lastUpdated>
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    <udiDi>00884883007307</udiDi>
    <basicUdiDi>B-00884883007307</basicUdiDi>
    <tradeName>00884883007307</tradeName>
    <deviceName>AcroMetrix NATBBV- Control</deviceName>
    <manufacturerName>Microgenics Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000030375</manufacturerSrn>
    <authorisedRepresentativeName>B·R·A·H·M·S GmbH</authorisedRepresentativeName>
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    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105080808</emdnCode>
    <emdnDescription>ALL INFECTIOUS DISEASES CONTROLS - NAT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>964600</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T09:24:29.781Z</lastUpdated>
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    <udiDi>00884883007291</udiDi>
    <basicUdiDi>B-00884883007291</basicUdiDi>
    <tradeName>00884883007291</tradeName>
    <deviceName>AcroMetrix HIVRNA+</deviceName>
    <manufacturerName>Microgenics Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000030375</manufacturerSrn>
    <authorisedRepresentativeName>B·R·A·H·M·S GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000026031</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105080808</emdnCode>
    <emdnDescription>ALL INFECTIOUS DISEASES CONTROLS - NAT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>961240</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T09:24:28.196Z</lastUpdated>
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