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    <tradeName>SpotChem D-Concept 2e (SD-4840)</tradeName>
    <deviceName>SpotChem D-Concept 2e (SD-4840)</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>W0201010105</emdnCode>
    <emdnDescription>CHEMISTRY ANALYSERS - LOW ROUTINE (with ISE mode test/h &lt;= 400)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>110046</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T04:34:00.392Z</lastUpdated>
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    <udiDi>04987486047186</udiDi>
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    <tradeName>SpotChem D-Concept 2c (SD-4830)</tradeName>
    <deviceName>SpotChem D-Concept 2c (SD-4830)</deviceName>
    <manufacturerName>ARKRAY Factory, Inc.</manufacturerName>
    <manufacturerSrn>JP-MF-000003008</manufacturerSrn>
    <authorisedRepresentativeName>ARKRAY Europe, B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002056</authorisedRepresentativeSrn>
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    <legislation>IVDR 2017/746</legislation>
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    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T04:33:58.788Z</lastUpdated>
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    <udiDi>04987486044604</udiDi>
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    <tradeName>WeCheck for S onyx</tradeName>
    <deviceName>WeCheck for S onyx</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>W020106019082</emdnCode>
    <emdnDescription>VARIOUS DIABETES MONITORING INSTRUMENTS - SOFTWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>109504</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-31T04:33:57.989Z</lastUpdated>
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    <udiDi>04987486039594</udiDi>
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    <tradeName>AutionIDaten (AE-4070)</tradeName>
    <deviceName>AutionIDaten (AE-4070)</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>W020101020102</emdnCode>
    <emdnDescription>SEMI-AUTOMATED URINE ANALYSERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>108412</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T04:33:53.988Z</lastUpdated>
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    <udiDi>04987486039044</udiDi>
    <basicUdiDi>4987486BC0108223GL</basicUdiDi>
    <tradeName>The Lab 001 (CE-8810)</tradeName>
    <deviceName>The Lab 001 (CE-8810)</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>W020105010202</emdnCode>
    <emdnDescription>CAPILLARY ELECTROPHORESIS SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>108223</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T04:33:45.984Z</lastUpdated>
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    <udiDi>04987486038009</udiDi>
    <basicUdiDi>4987486BC0107975J3</basicUdiDi>
    <tradeName>SPOTCHEM EL (SE-1520)</tradeName>
    <deviceName>SPOTCHEM EL (SE-1520)</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>W0201040201</emdnCode>
    <emdnDescription>ION SELECTIVE ELECTROLYTE ANALYSERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>107975</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T04:33:45.177Z</lastUpdated>
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    <udiDi>04987486036227</udiDi>
    <basicUdiDi>4987486BC0107687HT</basicUdiDi>
    <tradeName>PocketChem BA (PA-4140)</tradeName>
    <deviceName>PocketChem BA (PA-4140)</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>W0201010203</emdnCode>
    <emdnDescription>BLOOD-AMMONIA CHECKERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>107687</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T04:33:43.576Z</lastUpdated>
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    <udiDi>04987486034605</udiDi>
    <basicUdiDi>4987486BC0107507GW</basicUdiDi>
    <tradeName>SPOTCHEM D-00 QR (SD-9811)</tradeName>
    <deviceName>SPOTCHEM D-00 QR (SD-9811)</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>W0201030180</emdnCode>
    <emdnDescription>MIXED PANEL MULTIPARAMETER ANALYSERS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>107507</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T04:33:39.576Z</lastUpdated>
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    <udiDi>04987486034582</udiDi>
    <basicUdiDi>4987486BC0107505GS</basicUdiDi>
    <tradeName>SPOTCHEM D-03 (SD-4820)</tradeName>
    <deviceName>SPOTCHEM D-03 (SD-4820)</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>W0201030101</emdnCode>
    <emdnDescription>MIXED PANEL MULTIPARAMETER ANALYSERS - LOW ROUTINE (Throughput &lt;= 800 test/h)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>107505</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T04:33:38.784Z</lastUpdated>
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    <udiDi>04987486034575</udiDi>
    <basicUdiDi>4987486BC0107504GQ</basicUdiDi>
    <tradeName>SPOTCHEM D-02 (SD-4810)</tradeName>
    <deviceName>SPOTCHEM D-02 (SD-4810)</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>W0201030101</emdnCode>
    <emdnDescription>MIXED PANEL MULTIPARAMETER ANALYSERS - LOW ROUTINE (Throughput &lt;= 800 test/h)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>107504</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T04:33:37.178Z</lastUpdated>
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    <udiDi>04987486034568</udiDi>
    <basicUdiDi>4987486BC0107503GN</basicUdiDi>
    <tradeName>SPOTCHEM D-01 (SD-3810)</tradeName>
    <deviceName>SPOTCHEM D-01 (SD-3810)</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>W0201030101</emdnCode>
    <emdnDescription>MIXED PANEL MULTIPARAMETER ANALYSERS - LOW ROUTINE (Throughput &lt;= 800 test/h)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>107503</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T04:33:33.191Z</lastUpdated>
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    <udiDi>04987486034551</udiDi>
    <basicUdiDi>4987486BC0107501GJ</basicUdiDi>
    <tradeName>SPOTCHEM EZ (SP-4430)</tradeName>
    <deviceName>SPOTCHEM EZ (SP-4430)</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>W0201010101</emdnCode>
    <emdnDescription>CHEMISTRY ANALYSERS - LOW ROUTINE (Random access without ISE mode test/h &lt;= 400)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>107501</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T04:33:32.386Z</lastUpdated>
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    <udiDi>04987486033769</udiDi>
    <basicUdiDi>4987486BC0107377H9</basicUdiDi>
    <tradeName>ADAMS A1c Lite (HA-8380V)</tradeName>
    <deviceName>ADAMS A1c Lite (HA-8380V)</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>W0201050201</emdnCode>
    <emdnDescription>HIGH PERFORMANCE LIQUID CHROMATOGRAPHY SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>107377</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T04:33:30.773Z</lastUpdated>
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    <udiDi>04987486033684</udiDi>
    <basicUdiDi>4987486BC0107369HA</basicUdiDi>
    <tradeName>COLUMN UNIT 90</tradeName>
    <deviceName>COLUMN UNIT 90</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>W0201050280</emdnCode>
    <emdnDescription>HIGH PERFORMANCE LIQUID CHROMATOGRAPHY SYSTEMS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>107369</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T04:33:13.927Z</lastUpdated>
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    <udiDi>04987486033660</udiDi>
    <basicUdiDi>4987486BC0107366H4</basicUdiDi>
    <tradeName>ADAMS A1c (HA-8190V)</tradeName>
    <deviceName>ADAMS A1c (HA-8190V)</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>W0201050201</emdnCode>
    <emdnDescription>HIGH PERFORMANCE LIQUID CHROMATOGRAPHY SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>107366</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T04:33:10.243Z</lastUpdated>
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    <udiDi>04987486033639</udiDi>
    <basicUdiDi>4987486BC0107363GW</basicUdiDi>
    <tradeName>COLUMN UNIT 80T</tradeName>
    <deviceName>COLUMN UNIT 80T</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>W0201050280</emdnCode>
    <emdnDescription>HIGH PERFORMANCE LIQUID CHROMATOGRAPHY SYSTEMS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>107363</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T04:33:09.116Z</lastUpdated>
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    <udiDi>04987486033622</udiDi>
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    <tradeName>ADAMS A1c (HA-8180T)</tradeName>
    <deviceName>ADAMS A1c (HA-8180T)</deviceName>
    <manufacturerName>ARKRAY Factory, Inc.</manufacturerName>
    <manufacturerSrn>JP-MF-000003008</manufacturerSrn>
    <authorisedRepresentativeName>ARKRAY Europe, B.V.</authorisedRepresentativeName>
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    <riskClass>IVD Sınıf A</riskClass>
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    <emdnCode>W0201050201</emdnCode>
    <emdnDescription>HIGH PERFORMANCE LIQUID CHROMATOGRAPHY SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>107361</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T04:33:08.338Z</lastUpdated>
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    <udiDi>04987486033509</udiDi>
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    <deviceName>COLUMN UNIT 80</deviceName>
    <manufacturerName>ARKRAY Factory, Inc.</manufacturerName>
    <manufacturerSrn>JP-MF-000003008</manufacturerSrn>
    <authorisedRepresentativeName>ARKRAY Europe, B.V.</authorisedRepresentativeName>
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    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201050280</emdnCode>
    <emdnDescription>HIGH PERFORMANCE LIQUID CHROMATOGRAPHY SYSTEMS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>107345</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T04:33:02.729Z</lastUpdated>
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    <tradeName>ADAMS A1c (HA-8180V)</tradeName>
    <deviceName>ADAMS A1c (HA-8180V)</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>W0201050201</emdnCode>
    <emdnDescription>HIGH PERFORMANCE LIQUID CHROMATOGRAPHY SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>107342</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T04:33:01.935Z</lastUpdated>
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    <tradeName>PocketChem UA (PU-4010)</tradeName>
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    <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>W020101020102</emdnCode>
    <emdnDescription>SEMI-AUTOMATED URINE ANALYSERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>107332</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T04:33:01.112Z</lastUpdated>
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