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    <tradeName>06952804837099</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Assure Tech. (Hangzhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000002170</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C905005</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T20:00:22.468Z</lastUpdated>
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    <udiDi>06952804837112</udiDi>
    <basicUdiDi>B-06952804837112</basicUdiDi>
    <tradeName>06952804837112</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Assure Tech. (Hangzhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000002170</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C904005</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T20:00:21.874Z</lastUpdated>
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    <udiDi>06952804825867</udiDi>
    <basicUdiDi>B-06952804825867</basicUdiDi>
    <tradeName>06952804825867</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Assure Tech. (Hangzhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000002170</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>G112A08X</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T20:00:13.148Z</lastUpdated>
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    <udiDi>06952804837075</udiDi>
    <basicUdiDi>B-06952804837075</basicUdiDi>
    <tradeName>06952804837075</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Assure Tech. (Hangzhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000002170</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>G100A08X</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T20:00:12.961Z</lastUpdated>
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    <udiDi>06952804837082</udiDi>
    <basicUdiDi>B-06952804837082</basicUdiDi>
    <tradeName>06952804837082</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Assure Tech. (Hangzhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000002170</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>G217A08X</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T20:00:12.666Z</lastUpdated>
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    <udiDi>06952804825645</udiDi>
    <basicUdiDi>69528048CLI1000XN4</basicUdiDi>
    <tradeName>06952804825645</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Assure Tech. (Hangzhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000002170</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CLI1000X</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-29T20:00:08.543Z</lastUpdated>
  </row>
  <row>
    <udiDi>06952804835088</udiDi>
    <basicUdiDi>69528048LAC-101FF</basicUdiDi>
    <tradeName>Lactate Test Meter</tradeName>
    <deviceName>Lactate Test Meter</deviceName>
    <manufacturerName>Assure Tech. (Hangzhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000002170</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201069099</emdnCode>
    <emdnDescription>VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LAC-101</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-28T09:34:37.743Z</lastUpdated>
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  <row>
    <udiDi>06952804835071</udiDi>
    <basicUdiDi>69528048GPHB-101UT</basicUdiDi>
    <tradeName>G6PD and Hemoglobin Biosensor Test Meter</tradeName>
    <deviceName>G6PD and Hemoglobin Biosensor Test Meter</deviceName>
    <manufacturerName>Assure Tech. (Hangzhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000002170</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201069099</emdnCode>
    <emdnDescription>VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GPHB-101</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-28T09:34:34.262Z</lastUpdated>
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  <row>
    <udiDi>06952804835064</udiDi>
    <basicUdiDi>69528048CS-S01MK</basicUdiDi>
    <tradeName>Saliva Collection System</tradeName>
    <deviceName>Saliva Collection System</deviceName>
    <manufacturerName>Assure Tech. (Hangzhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000002170</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W05019002</emdnCode>
    <emdnDescription>SALIVA COLLECTION DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CS-S01，CS-S02</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-28T09:34:31.740Z</lastUpdated>
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  <row>
    <udiDi>06952804835057</udiDi>
    <basicUdiDi>69528048ADT100JP</basicUdiDi>
    <tradeName>Colloidal Immunoassay Analyzer</tradeName>
    <deviceName>Colloidal Immunoassay Analyzer</deviceName>
    <manufacturerName>Assure Tech. (Hangzhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000002170</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201069099</emdnCode>
    <emdnDescription>VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ADT100</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-28T09:34:30.534Z</lastUpdated>
  </row>
  <row>
    <udiDi>06952804835040</udiDi>
    <basicUdiDi>69528048TFL1000RG</basicUdiDi>
    <tradeName>Fluorescence Immunoassay Analyzer</tradeName>
    <deviceName>Fluorescence Immunoassay Analyzer</deviceName>
    <manufacturerName>Assure Tech. (Hangzhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000002170</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201069099</emdnCode>
    <emdnDescription>VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TFL1000</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-28T09:34:27.346Z</lastUpdated>
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  <row>
    <udiDi>06952804835033</udiDi>
    <basicUdiDi>69528048GOH-101ProH4</basicUdiDi>
    <tradeName>Blood Glucose Test Meter</tradeName>
    <deviceName>Blood Glucose Test Meter</deviceName>
    <manufacturerName>Assure Tech. (Hangzhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000002170</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201069099</emdnCode>
    <emdnDescription>VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GOH-101Pro</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-28T09:34:23.355Z</lastUpdated>
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  <row>
    <udiDi>06952804835019</udiDi>
    <basicUdiDi>69528048ACG10000CV</basicUdiDi>
    <tradeName>Colloidal Gold Test Analyzer</tradeName>
    <deviceName>Colloidal Gold Test Analyzer</deviceName>
    <manufacturerName>Assure Tech. (Hangzhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000002170</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201069099</emdnCode>
    <emdnDescription>VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ACG1000</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-28T09:34:21.032Z</lastUpdated>
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  <row>
    <udiDi>06952804835002</udiDi>
    <basicUdiDi>69528048HbA1C-1018B</basicUdiDi>
    <tradeName>Portable Glycosylated Hemoglobin Analyzer</tradeName>
    <deviceName>Portable Glycosylated Hemoglobin Analyzer</deviceName>
    <manufacturerName>Assure Tech. (Hangzhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000002170</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201069099</emdnCode>
    <emdnDescription>VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HbA1c-101</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-28T09:34:20.256Z</lastUpdated>
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    <udiDi>06952804834999</udiDi>
    <basicUdiDi>69528048JB00F00CB</basicUdiDi>
    <tradeName>Fully Automatic Biochemistry Analyzer</tradeName>
    <deviceName>Fully Automatic Biochemistry Analyzer</deviceName>
    <manufacturerName>Assure Tech. (Hangzhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000002170</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201069099</emdnCode>
    <emdnDescription>VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AS-60C</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-28T09:34:17.341Z</lastUpdated>
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    <udiDi>06952804834982</udiDi>
    <basicUdiDi>69528048C9040002X</basicUdiDi>
    <tradeName>Blood Glucose and β-Ketone Test Meter</tradeName>
    <deviceName>Blood Glucose and β-Ketone Test Meter</deviceName>
    <manufacturerName>Assure Tech. (Hangzhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000002170</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201069099</emdnCode>
    <emdnDescription>VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>69528048C9040002X</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-28T09:34:14.160Z</lastUpdated>
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    <udiDi>06952804834975</udiDi>
    <basicUdiDi>69528048C9030002Q</basicUdiDi>
    <tradeName>Blood Glucose and Uric Acid Test Meter</tradeName>
    <deviceName>Blood Glucose and Uric Acid Test Meter</deviceName>
    <manufacturerName>Assure Tech. (Hangzhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000002170</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201069099</emdnCode>
    <emdnDescription>VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GUE-101</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-28T09:34:10.277Z</lastUpdated>
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    <udiDi>06952804834968</udiDi>
    <basicUdiDi>695280480857K9</basicUdiDi>
    <tradeName>Handheld DOA Reader</tradeName>
    <deviceName>Handheld DOA Reader</deviceName>
    <manufacturerName>Assure Tech. (Hangzhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000002170</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201069099</emdnCode>
    <emdnDescription>VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ADT2000</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-28T09:34:08.915Z</lastUpdated>
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    <udiDi>06952804833503</udiDi>
    <basicUdiDi>69528048FOB-B001NL</basicUdiDi>
    <tradeName>Fecal Occult Blood Buffer</tradeName>
    <deviceName>Fecal Occult Blood Buffer</deviceName>
    <manufacturerName>Assure Tech. (Hangzhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000002170</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105900201</emdnCode>
    <emdnDescription>BUFFERS (UNASSIGNABLE ), SUPPLEM. REAGENTS, ETC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FOB-B001</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-28T09:34:06.517Z</lastUpdated>
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  <row>
    <udiDi>06952804833459</udiDi>
    <basicUdiDi>69528048A030100WF</basicUdiDi>
    <tradeName>Human Chorionic Gonadotropin Combo Rapid Test (20/20mIU)</tradeName>
    <deviceName>Human Chorionic Gonadotropin Combo Rapid Test (20/20mIU)</deviceName>
    <manufacturerName>Assure Tech. (Hangzhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000002170</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102050205</emdnCode>
    <emdnDescription>TOTAL HUMAN CHORIONIC GONADOTROPIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Format(Strip):A02600;Format(Device):A03010</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-28T09:34:03.388Z</lastUpdated>
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