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    <deviceName>dIFine DNA Classifier</deviceName>
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    <legislation>IVDR 2017/746</legislation>
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    <lastUpdated>2026-07-03T09:22:09.778Z</lastUpdated>
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    <basicUdiDi>805930434dIFineANAMG</basicUdiDi>
    <tradeName>08059304340215</tradeName>
    <deviceName>dIFine ANA HEp-2 Classifier</deviceName>
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    <tradeName>EVO SYSTEM PLUS</tradeName>
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    <manufacturerName>ABD SRL</manufacturerName>
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    <basicUdiDi>805432095AL1200ANALYZER72</basicUdiDi>
    <tradeName>AL1200 analyzer 120</tradeName>
    <deviceName>AL1200 analyzer 120</deviceName>
    <manufacturerName>Technogenetics S.p.A</manufacturerName>
    <manufacturerSrn>IT-MF-000025331</manufacturerSrn>
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    <emdnDescription>AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE ROUTINE (Throughput &gt; 100 and &lt;= 250 test/h)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AL800001</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T07:04:42.131Z</lastUpdated>
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    <udiDi>80536089444764</udiDi>
    <basicUdiDi>805360894ES0000859</basicUdiDi>
    <tradeName>Pulsar 350</tradeName>
    <deviceName>Pulsar 350 - Automated Immunochemistry Analyser</deviceName>
    <manufacturerName>Edif Instruments S.r.l.</manufacturerName>
    <manufacturerSrn>IT-MF-000009556</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
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    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201020103</emdnCode>
    <emdnDescription>AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE TO HIGH ROUTINE (Throughput &gt; 250 and &lt;= 700 test/h)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ES00008</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T06:56:53.020Z</lastUpdated>
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    <udiDi>80536089442234</udiDi>
    <basicUdiDi>805360894KIT08009NU</basicUdiDi>
    <tradeName>NeaT LX Latex Removal Solution 3 x 27 mL</tradeName>
    <deviceName>NeaT LX Latex Removal Solution</deviceName>
    <manufacturerName>Edif Instruments S.r.l.</manufacturerName>
    <manufacturerSrn>IT-MF-000009556</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
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    <emdnCode>W0201020185</emdnCode>
    <emdnDescription>AUTOMATED IMMUNOCHEMISTRY ANALYSERS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KIT08009E-081B</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T06:56:49.032Z</lastUpdated>
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    <udiDi>80536089401330</udiDi>
    <basicUdiDi>805360894KIT08006NN</basicUdiDi>
    <tradeName>NeaT C Cleaning solution 2 x 250 mL</tradeName>
    <deviceName>NeaT C Cleaning solution</deviceName>
    <manufacturerName>Edif Instruments S.r.l.</manufacturerName>
    <manufacturerSrn>IT-MF-000009556</manufacturerSrn>
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    <legislation>IVDR 2017/746</legislation>
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    <emdnDescription>AUTOMATED IMMUNOCHEMISTRY ANALYSERS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KIT08006E-500B</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T06:56:47.418Z</lastUpdated>
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    <basicUdiDi>805360894KIT08005NL</basicUdiDi>
    <tradeName>NeaT S System solution 6 x 50 mL</tradeName>
    <deviceName>NeaT S System solution</deviceName>
    <manufacturerName>Edif Instruments S.r.l.</manufacturerName>
    <manufacturerSrn>IT-MF-000009556</manufacturerSrn>
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    <emdnDescription>AUTOMATED IMMUNOCHEMISTRY ANALYSERS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KIT08005E-300B</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T06:56:41.028Z</lastUpdated>
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    <udiDi>80536089400722</udiDi>
    <basicUdiDi>805360894ES000014T</basicUdiDi>
    <tradeName>Sphera</tradeName>
    <deviceName>Sphera</deviceName>
    <manufacturerName>Edif Instruments S.r.l.</manufacturerName>
    <manufacturerSrn>IT-MF-000009556</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201020102</emdnCode>
    <emdnDescription>AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE ROUTINE (Throughput &gt; 100 and &lt;= 250 test/h)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ES00001-B</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T06:56:24.962Z</lastUpdated>
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    <udiDi>80536089417102</udiDi>
    <basicUdiDi>805360894ACC0710067</basicUdiDi>
    <tradeName>Kit Accessories Sphera</tradeName>
    <deviceName>Kit Accessories</deviceName>
    <manufacturerName>Edif Instruments S.r.l.</manufacturerName>
    <manufacturerSrn>IT-MF-000009556</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
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    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201020180</emdnCode>
    <emdnDescription>AUTOMATED IMMUNOCHEMISTRY ANALYSERS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ACC07101A-001A</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T06:47:01.152Z</lastUpdated>
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    <udiDi>80536089412534</udiDi>
    <basicUdiDi>805360894ACC113015L</basicUdiDi>
    <tradeName>Device external USB pen digital data storage unit</tradeName>
    <deviceName>Device external USB pen digital data storage unit</deviceName>
    <manufacturerName>Edif Instruments S.r.l.</manufacturerName>
    <manufacturerSrn>IT-MF-000009556</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
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    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201020180</emdnCode>
    <emdnDescription>AUTOMATED IMMUNOCHEMISTRY ANALYSERS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ACC11301A-001B</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T06:47:00.346Z</lastUpdated>
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    <udiDi>80536089412466</udiDi>
    <basicUdiDi>805360894ACC100095E</basicUdiDi>
    <tradeName>Multi-device PC communication cable (3m)</tradeName>
    <deviceName>Multi-device PC communication cable (3m)</deviceName>
    <manufacturerName>Edif Instruments S.r.l.</manufacturerName>
    <manufacturerSrn>IT-MF-000009556</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
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    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201020180</emdnCode>
    <emdnDescription>AUTOMATED IMMUNOCHEMISTRY ANALYSERS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ACC10009A-001A</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T06:46:57.158Z</lastUpdated>
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    <udiDi>80536089412398</udiDi>
    <basicUdiDi>805360894CML10007FF</basicUdiDi>
    <tradeName>Peristaltic pump head 38 ml/min</tradeName>
    <deviceName>Peristaltic pump head 38 ml/min</deviceName>
    <manufacturerName>Edif Instruments S.r.l.</manufacturerName>
    <manufacturerSrn>IT-MF-000009556</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201020185</emdnCode>
    <emdnDescription>AUTOMATED IMMUNOCHEMISTRY ANALYSERS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CML10007A-001A</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T06:46:56.358Z</lastUpdated>
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    <basicUdiDi>805360894ACO07080BN</basicUdiDi>
    <tradeName>External desktop reagents barcode scanner</tradeName>
    <deviceName>External desktop reagents barcode scanner</deviceName>
    <manufacturerName>Edif Instruments S.r.l.</manufacturerName>
    <manufacturerSrn>IT-MF-000009556</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <emdnCode>W0201020180</emdnCode>
    <emdnDescription>AUTOMATED IMMUNOCHEMISTRY ANALYSERS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ACO07080A-001B</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T06:46:55.554Z</lastUpdated>
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    <basicUdiDi>805360894CML07075H6</basicUdiDi>
    <tradeName>Reaction segment with 24 wells (Single-use)</tradeName>
    <deviceName>Reaction segment with 24 wells (Single-use)</deviceName>
    <manufacturerName>Edif Instruments S.r.l.</manufacturerName>
    <manufacturerSrn>IT-MF-000009556</manufacturerSrn>
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    <emdnDescription>AUTOMATED IMMUNOCHEMISTRY ANALYSERS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CML07075A-001A</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T06:46:54.746Z</lastUpdated>
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    <tradeName>Closing lid for individual reagent position</tradeName>
    <deviceName>Closing lid for individual reagent position</deviceName>
    <manufacturerName>Edif Instruments S.r.l.</manufacturerName>
    <manufacturerSrn>IT-MF-000009556</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
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    <emdnDescription>AUTOMATED IMMUNOCHEMISTRY ANALYSERS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ACC07047A-001A</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T06:46:50.748Z</lastUpdated>
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    <tradeName>Tank for device special waste liquids (2 L)</tradeName>
    <deviceName>Tank for device special waste liquids (2 L)</deviceName>
    <manufacturerName>Edif Instruments S.r.l.</manufacturerName>
    <manufacturerSrn>IT-MF-000009556</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <emdnDescription>AUTOMATED IMMUNOCHEMISTRY ANALYSERS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T06:46:49.943Z</lastUpdated>
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    <tradeName>Tank for device cleaning solution liquid (2 L)</tradeName>
    <deviceName>Tank for device cleaning solution liquid (2 L)</deviceName>
    <manufacturerName>Edif Instruments S.r.l.</manufacturerName>
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    <authorisedRepresentativeName></authorisedRepresentativeName>
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    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201020180</emdnCode>
    <emdnDescription>AUTOMATED IMMUNOCHEMISTRY ANALYSERS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ACC07036A-001A</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T06:46:49.158Z</lastUpdated>
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    <tradeName>Reagent screw cap tube 10.8 x 44 mm 2mL</tradeName>
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    <manufacturerName>Edif Instruments S.r.l.</manufacturerName>
    <manufacturerSrn>IT-MF-000009556</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201020185</emdnCode>
    <emdnDescription>AUTOMATED IMMUNOCHEMISTRY ANALYSERS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CML10014A-001A</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T06:46:44.337Z</lastUpdated>
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    <tradeName>Adapter for CML07026A-001A / CML07013A-001A reagent bottles</tradeName>
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    <manufacturerName>Edif Instruments S.r.l.</manufacturerName>
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    <authorisedRepresentativeName></authorisedRepresentativeName>
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    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201020180</emdnCode>
    <emdnDescription>AUTOMATED IMMUNOCHEMISTRY ANALYSERS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ACC07028A-001B</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T06:46:42.742Z</lastUpdated>
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