<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>06978949820215</udiDi>
    <basicUdiDi>697894982NWS0058A</basicUdiDi>
    <tradeName>06978949820215</tradeName>
    <deviceName>V-Wipes</deviceName>
    <manufacturerName>NINGBO HEALTHWAY IMPORT &amp; EXPORT CO.,LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000048759</manufacturerSrn>
    <authorisedRepresentativeName>HyperCert Limited B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000047746</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>M020205</emdnCode>
    <emdnDescription>NON-WOVEN GAUZES IN ROLLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>90401</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-02T21:17:20.207Z</lastUpdated>
  </row>
  <row>
    <udiDi>06978949820123</udiDi>
    <basicUdiDi>697894982APN010X7</basicUdiDi>
    <tradeName>06978949820123</tradeName>
    <deviceName>PE Apron</deviceName>
    <manufacturerName>NINGBO HEALTHWAY IMPORT &amp; EXPORT CO.,LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000048759</manufacturerSrn>
    <authorisedRepresentativeName>HyperCert Limited B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000047746</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>T0299</emdnCode>
    <emdnDescription>PROTECTION DRAPES AND GARMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>90202</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-02T21:17:19.419Z</lastUpdated>
  </row>
  <row>
    <udiDi>06978949820116</udiDi>
    <basicUdiDi>697894982HC0010P8</basicUdiDi>
    <tradeName>06978949820116</tradeName>
    <deviceName>Non-woven Cap</deviceName>
    <manufacturerName>NINGBO HEALTHWAY IMPORT &amp; EXPORT CO.,LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000048759</manufacturerSrn>
    <authorisedRepresentativeName>HyperCert Limited B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000047746</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>T0207</emdnCode>
    <emdnDescription>CAPS AND HEADWEAR (EXCLUDING PERSONAL PROTECTIVE EQUIPMENT - PPE)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>90201</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-02T21:17:15.401Z</lastUpdated>
  </row>
  <row>
    <udiDi>06978949820109</udiDi>
    <basicUdiDi>697894982BC0010LS</basicUdiDi>
    <tradeName>06978949820109</tradeName>
    <deviceName>Bed Cover</deviceName>
    <manufacturerName>NINGBO HEALTHWAY IMPORT &amp; EXPORT CO.,LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000048759</manufacturerSrn>
    <authorisedRepresentativeName>HyperCert Limited B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000047746</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>T030502</emdnCode>
    <emdnDescription>BED AND STRETCHER HYGIENIC COVERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>90206</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-02T21:17:14.602Z</lastUpdated>
  </row>
  <row>
    <udiDi>06978949820086</udiDi>
    <basicUdiDi>697894982FM0030S2</basicUdiDi>
    <tradeName>06978949820086</tradeName>
    <deviceName>Face mask</deviceName>
    <manufacturerName>NINGBO HEALTHWAY IMPORT &amp; EXPORT CO.,LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000048759</manufacturerSrn>
    <authorisedRepresentativeName>HyperCert Limited B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000047746</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>T020604</emdnCode>
    <emdnDescription>MEDICAL USE FACE MASKS, TYPE II AND IIR</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>50064</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-02T21:17:13.827Z</lastUpdated>
  </row>
  <row>
    <udiDi>06978949820079</udiDi>
    <basicUdiDi>697894982DKD001UG</basicUdiDi>
    <tradeName>06978949820079</tradeName>
    <deviceName>Kidney Bowls</deviceName>
    <manufacturerName>NINGBO HEALTHWAY IMPORT &amp; EXPORT CO.,LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000048759</manufacturerSrn>
    <authorisedRepresentativeName>HyperCert Limited B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000047746</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>V0499</emdnCode>
    <emdnDescription>CLINICAL USE CONTAINERS (NON-IVD) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>90700</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-02T21:17:13.002Z</lastUpdated>
  </row>
  <row>
    <udiDi>06978949820048</udiDi>
    <basicUdiDi>697894982NWR0037X</basicUdiDi>
    <tradeName>06978949820048</tradeName>
    <deviceName>Non-woven</deviceName>
    <manufacturerName>NINGBO HEALTHWAY IMPORT &amp; EXPORT CO.,LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000048759</manufacturerSrn>
    <authorisedRepresentativeName>HyperCert Limited B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000047746</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>M020205</emdnCode>
    <emdnDescription>NON-WOVEN GAUZES IN ROLLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>90550</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-02T21:17:09.013Z</lastUpdated>
  </row>
  <row>
    <udiDi>06978949820031</udiDi>
    <basicUdiDi>697894982NWR0027V</basicUdiDi>
    <tradeName>06978949820031</tradeName>
    <deviceName>Non-woven</deviceName>
    <manufacturerName>NINGBO HEALTHWAY IMPORT &amp; EXPORT CO.,LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000048759</manufacturerSrn>
    <authorisedRepresentativeName>HyperCert Limited B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000047746</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>M020205</emdnCode>
    <emdnDescription>NON-WOVEN GAUZES IN ROLLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>90520</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-02T21:17:08.205Z</lastUpdated>
  </row>
  <row>
    <udiDi>06978949820024</udiDi>
    <basicUdiDi>697894982NWS00182</basicUdiDi>
    <tradeName>06978949820024</tradeName>
    <deviceName>Non-woven</deviceName>
    <manufacturerName>NINGBO HEALTHWAY IMPORT &amp; EXPORT CO.,LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000048759</manufacturerSrn>
    <authorisedRepresentativeName>HyperCert Limited B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000047746</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>M020204</emdnCode>
    <emdnDescription>NON-WOVEN GAUZES IN PIECES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>90511</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-02T21:17:07.409Z</lastUpdated>
  </row>
  <row>
    <udiDi>06978949820017</udiDi>
    <basicUdiDi>697894982DWC00015J</basicUdiDi>
    <tradeName>06978949820017</tradeName>
    <deviceName>Disposable Washcloths</deviceName>
    <manufacturerName>NINGBO HEALTHWAY IMPORT &amp; EXPORT CO.,LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000048759</manufacturerSrn>
    <authorisedRepresentativeName>HyperCert Limited B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000047746</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>M020204</emdnCode>
    <emdnDescription>NON-WOVEN GAUZES IN PIECES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>90500</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-02T21:17:06.965Z</lastUpdated>
  </row>
  <row>
    <udiDi>06978678610637</udiDi>
    <basicUdiDi>697867861WDF42</basicUdiDi>
    <tradeName>06978678610637</tradeName>
    <deviceName>Dental File</deviceName>
    <manufacturerName>SWORDENTAL CO.,LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000051060</manufacturerSrn>
    <authorisedRepresentativeName>HyperCert Limited B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000047746</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>L159019</emdnCode>
    <emdnDescription>DENTAL FINISHING RASPS AND FILES, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>K type</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-02T20:55:11.392Z</lastUpdated>
  </row>
  <row>
    <udiDi>06978678610019</udiDi>
    <basicUdiDi>697867861WDB3S</basicUdiDi>
    <tradeName>06978678610019</tradeName>
    <deviceName>Dental Bur</deviceName>
    <manufacturerName>SWORDENTAL CO.,LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000051060</manufacturerSrn>
    <authorisedRepresentativeName>HyperCert Limited B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000047746</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q010501</emdnCode>
    <emdnDescription>DENTAL BURS AND ABRASIVE DISKS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SD-1 Round</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-02T20:55:07.392Z</lastUpdated>
  </row>
  <row>
    <udiDi>06978465236606</udiDi>
    <basicUdiDi>697846523AGAUL</basicUdiDi>
    <tradeName>Automatic Glycohemoglobin Analyzer</tradeName>
    <deviceName>Automatic Glycohemoglobin Analyzer</deviceName>
    <manufacturerName>Shenzhen Dake Medical Technology Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000047336</manufacturerSrn>
    <authorisedRepresentativeName>HyperCert Limited B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000047746</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201060101</emdnCode>
    <emdnDescription>GLYCOSILATED HEMOGLOBIN DEVICEs</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Bright h600</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-02T20:35:13.727Z</lastUpdated>
  </row>
  <row>
    <udiDi>06978465236408</udiDi>
    <basicUdiDi>697846523TumorB019Q</basicUdiDi>
    <tradeName>Growth Hormone Assay kit(Chemiluminescence Immunoassay Method）</tradeName>
    <deviceName>Growth Hormone Assay kit(Chemiluminescence Immunoassay Method）</deviceName>
    <manufacturerName>Shenzhen Dake Medical Technology Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000047336</manufacturerSrn>
    <authorisedRepresentativeName>HyperCert Limited B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000047746</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102060402</emdnCode>
    <emdnDescription>HUMAN GROWTH HORMONE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>25 tests</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-02T20:35:12.924Z</lastUpdated>
  </row>
  <row>
    <udiDi>06978465236156</udiDi>
    <basicUdiDi>697846523OtherB03YS</basicUdiDi>
    <tradeName>Hyaluronic Acid Assay kit(Chemiluminescence Immunoassay Method）</tradeName>
    <deviceName>Hyaluronic Acid Assay kit(Chemiluminescence Immunoassay Method）</deviceName>
    <manufacturerName>Shenzhen Dake Medical Technology Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000047336</manufacturerSrn>
    <authorisedRepresentativeName>HyperCert Limited B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000047746</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102120103</emdnCode>
    <emdnDescription>HYALURONIC ACID</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>25 tests</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-02T20:35:12.102Z</lastUpdated>
  </row>
  <row>
    <udiDi>06978465236101</udiDi>
    <basicUdiDi>697846523OtherB01YN</basicUdiDi>
    <tradeName>Thrombin-antithrombin Assay kit(Chemiluminescence Immunoassay Method）</tradeName>
    <deviceName>Thrombin-antithrombin Assay kit(Chemiluminescence Immunoassay Method）</deviceName>
    <manufacturerName>Shenzhen Dake Medical Technology Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000047336</manufacturerSrn>
    <authorisedRepresentativeName>HyperCert Limited B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000047746</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103020307</emdnCode>
    <emdnDescription>THROMBIN-ANTITHROMBIN III-COMPLEX</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>25 tests</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-02T20:35:08.123Z</lastUpdated>
  </row>
  <row>
    <udiDi>06978465235951</udiDi>
    <basicUdiDi>697846523HormoneB19JA</basicUdiDi>
    <tradeName>Adrenocorticotropic Hormone Assay kit(Chemiluminescence Immunoassay Method）</tradeName>
    <deviceName>Adrenocorticotropic Hormone Assay kit(Chemiluminescence Immunoassay Method）</deviceName>
    <manufacturerName>Shenzhen Dake Medical Technology Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000047336</manufacturerSrn>
    <authorisedRepresentativeName>HyperCert Limited B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000047746</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102060401</emdnCode>
    <emdnDescription>ADRENOCORTIOTROPIC HORMONE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>25 tests</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-02T20:35:07.301Z</lastUpdated>
  </row>
  <row>
    <udiDi>06978465235906</udiDi>
    <basicUdiDi>697846523HormoneB18J8</basicUdiDi>
    <tradeName>Sex Hormone Binding Globulin Assay kit(Chemiluminescence Immunoassay Method）</tradeName>
    <deviceName>Sex Hormone Binding Globulin Assay kit(Chemiluminescence Immunoassay Method）</deviceName>
    <manufacturerName>Shenzhen Dake Medical Technology Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000047336</manufacturerSrn>
    <authorisedRepresentativeName>HyperCert Limited B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000047746</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102050109</emdnCode>
    <emdnDescription>SEX HORMONE BINDING GLOBULIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>25 tests</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-02T20:35:06.502Z</lastUpdated>
  </row>
  <row>
    <udiDi>06978465235654</udiDi>
    <basicUdiDi>697846523ProteinB10R9</basicUdiDi>
    <tradeName>Laminin Assay kit(Chemiluminescence Immunoassay Method）</tradeName>
    <deviceName>Laminin Assay kit(Chemiluminescence Immunoassay Method）</deviceName>
    <manufacturerName>Shenzhen Dake Medical Technology Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000047336</manufacturerSrn>
    <authorisedRepresentativeName>HyperCert Limited B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000047746</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102039006</emdnCode>
    <emdnDescription>LAMININ</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>25 tests</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-02T20:35:05.702Z</lastUpdated>
  </row>
  <row>
    <udiDi>06978465235470</udiDi>
    <basicUdiDi>697846523HormoneB10HQ</basicUdiDi>
    <tradeName>Anti-Mullerian Hormone Assay kit(Chemiluminescence Immunoassay Method）</tradeName>
    <deviceName>Anti-Mullerian Hormone Assay kit(Chemiluminescence Immunoassay Method）</deviceName>
    <manufacturerName>Shenzhen Dake Medical Technology Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000047336</manufacturerSrn>
    <authorisedRepresentativeName>HyperCert Limited B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000047746</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102050215</emdnCode>
    <emdnDescription>ANTI-MÛLLERIAN HORMONE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2×100 test</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-02T20:35:01.719Z</lastUpdated>
  </row>
</eudamedExport>