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<eudamedExport entity="devices">
  <row>
    <udiDi>00816426020115</udiDi>
    <basicUdiDi>B-00816426020115</basicUdiDi>
    <tradeName>K-ASSAY IgM</tradeName>
    <deviceName>IgM Reagent</deviceName>
    <manufacturerName>KAMIYA BIOMEDICAL COMPANY, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000002769</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102010107</emdnCode>
    <emdnDescription>IMMUNOGLOBULIN M</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KAI-015</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-04T18:38:05.253Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816426020108</udiDi>
    <basicUdiDi>B-00816426020108</basicUdiDi>
    <tradeName>K-ASSAY IgG</tradeName>
    <deviceName>IgG Reagent</deviceName>
    <manufacturerName>KAMIYA BIOMEDICAL COMPANY, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000002769</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102010105</emdnCode>
    <emdnDescription>IMMUNOGLOBULIN G</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KAI-014</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-04T18:38:04.456Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816426020092</udiDi>
    <basicUdiDi>B-00816426020092</basicUdiDi>
    <tradeName>K-ASSAY IgA</tradeName>
    <deviceName>IgA Reagent</deviceName>
    <manufacturerName>KAMIYA BIOMEDICAL COMPANY, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000002769</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102010101</emdnCode>
    <emdnDescription>IMMUNOGLOBULIN A</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KAI-013</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-04T18:36:27.498Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816426020085</udiDi>
    <basicUdiDi>B-00816426020085</basicUdiDi>
    <tradeName>K-ASSAY Complement C4</tradeName>
    <deviceName>Complement C4 Reagent</deviceName>
    <manufacturerName>KAMIYA BIOMEDICAL COMPANY, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000002769</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102010205</emdnCode>
    <emdnDescription>COMPLEMENT COMPONENT C4</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KAI-010</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-04T18:36:26.677Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816426020078</udiDi>
    <basicUdiDi>B-00816426020078</basicUdiDi>
    <tradeName>K-ASSAY Complement C3</tradeName>
    <deviceName>Complement C3 Reagent</deviceName>
    <manufacturerName>KAMIYA BIOMEDICAL COMPANY, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000002769</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102010203</emdnCode>
    <emdnDescription>COMPLEMENT COMPONENT C3/C3C</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KAI-009</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-04T18:36:25.875Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816426020061</udiDi>
    <basicUdiDi>B-00816426020061</basicUdiDi>
    <tradeName>K-ASSAY Apo E</tradeName>
    <deviceName>Apo E Reagent</deviceName>
    <manufacturerName>KAMIYA BIOMEDICAL COMPANY, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000002769</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102010499</emdnCode>
    <emdnDescription>LIPOPROTEINS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KAI-007</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-04T18:36:25.089Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816426020054</udiDi>
    <basicUdiDi>B-00816426020054</basicUdiDi>
    <tradeName>K-ASSAY Apo CIII</tradeName>
    <deviceName>Apo CIII Reagent</deviceName>
    <manufacturerName>KAMIYA BIOMEDICAL COMPANY, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000002769</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102010499</emdnCode>
    <emdnDescription>LIPOPROTEINS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KAI-006</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-04T18:36:21.068Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816426020047</udiDi>
    <basicUdiDi>B-00816426020047</basicUdiDi>
    <tradeName>K-ASSAY Apo CII</tradeName>
    <deviceName>Apo CII</deviceName>
    <manufacturerName>KAMIYA BIOMEDICAL COMPANY, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000002769</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102010499</emdnCode>
    <emdnDescription>LIPOPROTEINS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KAI-005</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-04T18:36:20.268Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816426020030</udiDi>
    <basicUdiDi>B-00816426020030</basicUdiDi>
    <tradeName>K-ASSAY Apo B</tradeName>
    <deviceName>Apo B Reagent</deviceName>
    <manufacturerName>KAMIYA BIOMEDICAL COMPANY, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000002769</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102010403</emdnCode>
    <emdnDescription>APOLIPOPROTEIN B</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KAI-004</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-04T18:36:19.466Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816426020023</udiDi>
    <basicUdiDi>B-00816426020023</basicUdiDi>
    <tradeName>K-ASSAY Apo AII</tradeName>
    <deviceName>Apo AII Reagent</deviceName>
    <manufacturerName>KAMIYA BIOMEDICAL COMPANY, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000002769</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102010402</emdnCode>
    <emdnDescription>APOLIPOPROTEIN A II</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KAI-003</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-04T18:36:18.673Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816426020016</udiDi>
    <basicUdiDi>B-00816426020016</basicUdiDi>
    <tradeName>K-ASSAY Apo AI</tradeName>
    <deviceName>Apo AI Reagent</deviceName>
    <manufacturerName>KAMIYA BIOMEDICAL COMPANY, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000002769</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102010401</emdnCode>
    <emdnDescription>APOLIPOPROTEIN A I</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KAI-002</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-04T18:36:14.685Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816207021706</udiDi>
    <basicUdiDi>B-00816207021706</basicUdiDi>
    <tradeName>00816207021706</tradeName>
    <deviceName>Biopsy Brush</deviceName>
    <manufacturerName>Endo-Therapeutics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000002267</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>G03080399</emdnCode>
    <emdnDescription>GASTROINTESTINAL ENDOSCOPY AND ECHOENDOSCOPY, BRUSHES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TNL-80</reference>
    <placedOnMarketCountry>Malta</placedOnMarketCountry>
    <lastUpdated>2026-07-04T18:30:13.238Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816207021157</udiDi>
    <basicUdiDi>B-00816207021157</basicUdiDi>
    <tradeName>EndoTNeedle</tradeName>
    <deviceName>Endoscopic Injection Needle</deviceName>
    <manufacturerName>Endo-Therapeutics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000002267</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>G03020101</emdnCode>
    <emdnDescription>DIGESTIVE ENDOSCOPY, SINGLE-LUMEN NEEDLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ET1322</reference>
    <placedOnMarketCountry>Malta</placedOnMarketCountry>
    <lastUpdated>2026-07-04T18:30:09.239Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816207021140</udiDi>
    <basicUdiDi>B-00816207021140</basicUdiDi>
    <tradeName>EndoTNeedle</tradeName>
    <deviceName>Endoscopic Injection Needle</deviceName>
    <manufacturerName>Endo-Therapeutics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000002267</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>G03020101</emdnCode>
    <emdnDescription>DIGESTIVE ENDOSCOPY, SINGLE-LUMEN NEEDLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ET1321</reference>
    <placedOnMarketCountry>Malta</placedOnMarketCountry>
    <lastUpdated>2026-07-04T18:30:08.437Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816207021690</udiDi>
    <basicUdiDi>B-00816207021690</basicUdiDi>
    <tradeName>00816207021690</tradeName>
    <deviceName>Biopsy Brush</deviceName>
    <manufacturerName>Endo-Therapeutics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000002267</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>G03080399</emdnCode>
    <emdnDescription>GASTROINTESTINAL ENDOSCOPY AND ECHOENDOSCOPY, BRUSHES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TNE-110</reference>
    <placedOnMarketCountry>Malta</placedOnMarketCountry>
    <lastUpdated>2026-07-04T18:30:07.632Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816207021164</udiDi>
    <basicUdiDi>B-00816207021164</basicUdiDi>
    <tradeName>EndoTNeedle</tradeName>
    <deviceName>Endoscopic Injection Needle</deviceName>
    <manufacturerName>Endo-Therapeutics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000002267</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>G03020101</emdnCode>
    <emdnDescription>DIGESTIVE ENDOSCOPY, SINGLE-LUMEN NEEDLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ET1323</reference>
    <placedOnMarketCountry>Malta</placedOnMarketCountry>
    <lastUpdated>2026-07-04T18:30:06.839Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816207021133</udiDi>
    <basicUdiDi>B-00816207021133</basicUdiDi>
    <tradeName>EndoTNeedle</tradeName>
    <deviceName>Endoscopic Injection Needle</deviceName>
    <manufacturerName>Endo-Therapeutics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000002267</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>G03020101</emdnCode>
    <emdnDescription>DIGESTIVE ENDOSCOPY, SINGLE-LUMEN NEEDLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ET1320</reference>
    <placedOnMarketCountry>Malta</placedOnMarketCountry>
    <lastUpdated>2026-07-04T18:29:49.172Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816207021065</udiDi>
    <basicUdiDi>B-00816207021065</basicUdiDi>
    <tradeName>EndoTNeedle</tradeName>
    <deviceName>Endoscopic Injection Needle</deviceName>
    <manufacturerName>Endo-Therapeutics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000002267</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>G03020101</emdnCode>
    <emdnDescription>DIGESTIVE ENDOSCOPY, SINGLE-LUMEN NEEDLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ET1303</reference>
    <placedOnMarketCountry>Malta</placedOnMarketCountry>
    <lastUpdated>2026-07-04T18:29:48.378Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816207021058</udiDi>
    <basicUdiDi>B-00816207021058</basicUdiDi>
    <tradeName>EndoTNeedle</tradeName>
    <deviceName>Endoscopic Injection Needle</deviceName>
    <manufacturerName>Endo-Therapeutics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000002267</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>G03020101</emdnCode>
    <emdnDescription>DIGESTIVE ENDOSCOPY, SINGLE-LUMEN NEEDLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ET1301</reference>
    <placedOnMarketCountry>Malta</placedOnMarketCountry>
    <lastUpdated>2026-07-04T18:29:47.573Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816207021041</udiDi>
    <basicUdiDi>B-00816207021041</basicUdiDi>
    <tradeName>00816207021041</tradeName>
    <deviceName>Biopsy Brush</deviceName>
    <manufacturerName>Endo-Therapeutics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000002267</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>G03080399</emdnCode>
    <emdnDescription>GASTROINTESTINAL ENDOSCOPY AND ECHOENDOSCOPY, BRUSHES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EGD-230-006</reference>
    <placedOnMarketCountry>Malta</placedOnMarketCountry>
    <lastUpdated>2026-07-04T18:29:46.790Z</lastUpdated>
  </row>
</eudamedExport>