<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>08699015281713</udiDi>
    <basicUdiDi>B-08699015281713</basicUdiDi>
    <tradeName>CK-MB KİTİ</tradeName>
    <deviceName>CK-MB REAGENT</deviceName>
    <manufacturerName>ARCHEM SAĞLIK SANAYİ VE TİCARET ANONİM ŞİRKETİ</manufacturerName>
    <manufacturerSrn>TR-MF-000027166</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010114</emdnCode>
    <emdnDescription>CREATINE KINASE - MB ACTIVITY (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>01R88-31</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-09T13:12:25.219Z</lastUpdated>
  </row>
  <row>
    <udiDi>08699015281706</udiDi>
    <basicUdiDi>B-08699015281706</basicUdiDi>
    <tradeName>HBA1C DİREKT KİTİ</tradeName>
    <deviceName>HBA1C DIRECT REAGENT</deviceName>
    <manufacturerName>ARCHEM SAĞLIK SANAYİ VE TİCARET ANONİM ŞİRKETİ</manufacturerName>
    <manufacturerSrn>TR-MF-000027166</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010214</emdnCode>
    <emdnDescription>GLYCOSYLATED/GLYCATED HAEMOGLOBIN (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>01R87-31</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-09T13:12:24.419Z</lastUpdated>
  </row>
  <row>
    <udiDi>08699015281690</udiDi>
    <basicUdiDi>B-08699015281690</basicUdiDi>
    <tradeName>HBA1C DİREKT KİTİ</tradeName>
    <deviceName>HBA1C DIRECT REAGENT</deviceName>
    <manufacturerName>ARCHEM SAĞLIK SANAYİ VE TİCARET ANONİM ŞİRKETİ</manufacturerName>
    <manufacturerSrn>TR-MF-000027166</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010214</emdnCode>
    <emdnDescription>GLYCOSYLATED/GLYCATED HAEMOGLOBIN (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>01R87-21</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-09T13:12:23.625Z</lastUpdated>
  </row>
  <row>
    <udiDi>08699015281683</udiDi>
    <basicUdiDi>B-08699015281683</basicUdiDi>
    <tradeName>HBA1C DİREKT KİTİ</tradeName>
    <deviceName>HBA1C DIRECT REAGENT</deviceName>
    <manufacturerName>ARCHEM SAĞLIK SANAYİ VE TİCARET ANONİM ŞİRKETİ</manufacturerName>
    <manufacturerSrn>TR-MF-000027166</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010214</emdnCode>
    <emdnDescription>GLYCOSYLATED/GLYCATED HAEMOGLOBIN (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>01R87-41</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-09T13:12:22.823Z</lastUpdated>
  </row>
  <row>
    <udiDi>08699015281676</udiDi>
    <basicUdiDi>B-08699015281676</basicUdiDi>
    <tradeName>HBA1C DİREKT KİTİ</tradeName>
    <deviceName>HBA1C DIRECT REAGENT</deviceName>
    <manufacturerName>ARCHEM SAĞLIK SANAYİ VE TİCARET ANONİM ŞİRKETİ</manufacturerName>
    <manufacturerSrn>TR-MF-000027166</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010214</emdnCode>
    <emdnDescription>GLYCOSYLATED/GLYCATED HAEMOGLOBIN (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>01R87-51</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-09T13:12:18.819Z</lastUpdated>
  </row>
  <row>
    <udiDi>08699015281669</udiDi>
    <basicUdiDi>B-08699015281669</basicUdiDi>
    <tradeName>ASO TÜRBİDİMETRİK KİTİ</tradeName>
    <deviceName>ASO TURBIDIMETRIC REAGENT</deviceName>
    <manufacturerName>ARCHEM SAĞLIK SANAYİ VE TİCARET ANONİM ŞİRKETİ</manufacturerName>
    <manufacturerSrn>TR-MF-000027166</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021104</emdnCode>
    <emdnDescription>ANTI-STREPTOLYSIN O (QUANTITATIVE)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>01R86-21</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-09T13:12:18.017Z</lastUpdated>
  </row>
  <row>
    <udiDi>08699015281645</udiDi>
    <basicUdiDi>B-08699015281645</basicUdiDi>
    <tradeName>DEMİR BAĞLAMA KAPASİTESİ KİTİ</tradeName>
    <deviceName>UIBC REAGENT</deviceName>
    <manufacturerName>ARCHEM SAĞLIK SANAYİ VE TİCARET ANONİM ŞİRKETİ</manufacturerName>
    <manufacturerSrn>TR-MF-000027166</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010217</emdnCode>
    <emdnDescription>IRON BINDING CAPACITY - TOTAL (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>01R85-21</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-09T13:12:17.216Z</lastUpdated>
  </row>
  <row>
    <udiDi>08699015281638</udiDi>
    <basicUdiDi>B-08699015281638</basicUdiDi>
    <tradeName>DEMİR BAĞLAMA KAPASİTESİ KİTİ</tradeName>
    <deviceName>UIBC REAGENT</deviceName>
    <manufacturerName>ARCHEM SAĞLIK SANAYİ VE TİCARET ANONİM ŞİRKETİ</manufacturerName>
    <manufacturerSrn>TR-MF-000027166</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010217</emdnCode>
    <emdnDescription>IRON BINDING CAPACITY - TOTAL (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>01R85-31</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-09T13:12:16.411Z</lastUpdated>
  </row>
  <row>
    <udiDi>08699015281621</udiDi>
    <basicUdiDi>B-08699015281621</basicUdiDi>
    <tradeName>DEMİR BAĞLAMA KAPASİTESİ KİTİ</tradeName>
    <deviceName>UIBC REAGENT</deviceName>
    <manufacturerName>ARCHEM SAĞLIK SANAYİ VE TİCARET ANONİM ŞİRKETİ</manufacturerName>
    <manufacturerSrn>TR-MF-000027166</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010217</emdnCode>
    <emdnDescription>IRON BINDING CAPACITY - TOTAL (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>01R85-41</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-09T13:12:12.419Z</lastUpdated>
  </row>
  <row>
    <udiDi>08699015281614</udiDi>
    <basicUdiDi>B-08699015281614</basicUdiDi>
    <tradeName>HDL KOLESTEROL DİREKT KİTİ</tradeName>
    <deviceName>HDL CHOLESTEROL DIRECT REAGENT</deviceName>
    <manufacturerName>ARCHEM SAĞLIK SANAYİ VE TİCARET ANONİM ŞİRKETİ</manufacturerName>
    <manufacturerSrn>TR-MF-000027166</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010215</emdnCode>
    <emdnDescription>HIGH DENSITY LIPOPROTEIN CHOLESTEROL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>02R06-21</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-09T13:12:11.614Z</lastUpdated>
  </row>
  <row>
    <udiDi>08699015281607</udiDi>
    <basicUdiDi>B-08699015281607</basicUdiDi>
    <tradeName>HDL KOLESTEROL DİREKT KİTİ</tradeName>
    <deviceName>HDL CHOLESTEROL DIRECT REAGENT</deviceName>
    <manufacturerName>ARCHEM SAĞLIK SANAYİ VE TİCARET ANONİM ŞİRKETİ</manufacturerName>
    <manufacturerSrn>TR-MF-000027166</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010215</emdnCode>
    <emdnDescription>HIGH DENSITY LIPOPROTEIN CHOLESTEROL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>02R06-31</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-09T13:12:10.827Z</lastUpdated>
  </row>
  <row>
    <udiDi>08699015281591</udiDi>
    <basicUdiDi>B-08699015281591</basicUdiDi>
    <tradeName>08699015281591</tradeName>
    <deviceName>LDL DIRECT CHOLESTEROL REAGENT</deviceName>
    <manufacturerName>ARCHEM SAĞLIK SANAYİ VE TİCARET ANONİM ŞİRKETİ</manufacturerName>
    <manufacturerSrn>TR-MF-000027166</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010221</emdnCode>
    <emdnDescription>LOW DENSITY LIPOPROTEIN CHOLESTEROL INCLUDING SD-LDL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>02R05-21</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-09T13:12:10.026Z</lastUpdated>
  </row>
  <row>
    <udiDi>08699015281584</udiDi>
    <basicUdiDi>B-08699015281584</basicUdiDi>
    <tradeName>LDL KOLESTEROL DİREKT KİTİ</tradeName>
    <deviceName>LDL CHOLESTEROL DIRECT REAGENT</deviceName>
    <manufacturerName>ARCHEM SAĞLIK SANAYİ VE TİCARET ANONİM ŞİRKETİ</manufacturerName>
    <manufacturerSrn>TR-MF-000027166</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010221</emdnCode>
    <emdnDescription>LOW DENSITY LIPOPROTEIN CHOLESTEROL INCLUDING SD-LDL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>02R05-31</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-09T13:12:06.016Z</lastUpdated>
  </row>
  <row>
    <udiDi>08699015281577</udiDi>
    <basicUdiDi>B-08699015281577</basicUdiDi>
    <tradeName>CRP TÜRBİDİMETRİK WR KİTİ</tradeName>
    <deviceName>CRP TURBIDIMETRIC WR REAGENT</deviceName>
    <manufacturerName>ARCHEM SAĞLIK SANAYİ VE TİCARET ANONİM ŞİRKETİ</manufacturerName>
    <manufacturerSrn>TR-MF-000027166</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021109</emdnCode>
    <emdnDescription>C-REACTIVE PROTEIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>02R04-21</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-09T13:12:05.209Z</lastUpdated>
  </row>
  <row>
    <udiDi>08699015281560</udiDi>
    <basicUdiDi>B-08699015281560</basicUdiDi>
    <tradeName>CRP TÜRBİDİMETRİK WR KİTİ</tradeName>
    <deviceName>CRP TURBIDIMETRIC WR REAGENT</deviceName>
    <manufacturerName>ARCHEM SAĞLIK SANAYİ VE TİCARET ANONİM ŞİRKETİ</manufacturerName>
    <manufacturerSrn>TR-MF-000027166</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021109</emdnCode>
    <emdnDescription>C-REACTIVE PROTEIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>02R04-31</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-09T13:12:04.419Z</lastUpdated>
  </row>
  <row>
    <udiDi>08699015280600</udiDi>
    <basicUdiDi>B-08699015280600</basicUdiDi>
    <tradeName>ALBÜMİN  KİTİ</tradeName>
    <deviceName>ALBUMIN REAGENT</deviceName>
    <manufacturerName>ARCHEM SAĞLIK SANAYİ VE TİCARET ANONİM ŞİRKETİ</manufacturerName>
    <manufacturerSrn>TR-MF-000027166</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010201</emdnCode>
    <emdnDescription>ALBUMIN (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A2010</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-09T13:12:03.609Z</lastUpdated>
  </row>
  <row>
    <udiDi>08681812534383</udiDi>
    <basicUdiDi>B-08681812534383</basicUdiDi>
    <tradeName>MİKROALBÜMİN KONTROL</tradeName>
    <deviceName>MICROALBUMIN CONTROL</deviceName>
    <manufacturerName>ARCHEM SAĞLIK SANAYİ VE TİCARET ANONİM ŞİRKETİ</manufacturerName>
    <manufacturerSrn>TR-MF-000027166</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050207</emdnCode>
    <emdnDescription>URINE CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A302M</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-08T15:42:14.381Z</lastUpdated>
  </row>
  <row>
    <udiDi>08681812534345</udiDi>
    <basicUdiDi>B-08681812534345</basicUdiDi>
    <tradeName>MİKROALBÜMİN KALİBRATÖR</tradeName>
    <deviceName>MICROALBUMIN CALIBRATOR</deviceName>
    <manufacturerName>ARCHEM SAĞLIK SANAYİ VE TİCARET ANONİM ŞİRKETİ</manufacturerName>
    <manufacturerSrn>TR-MF-000027166</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050302</emdnCode>
    <emdnDescription>CALIBRATORS SINGLE COMPONENT (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A301M</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-08T15:42:13.760Z</lastUpdated>
  </row>
  <row>
    <udiDi>08681812532815</udiDi>
    <basicUdiDi>B-08681812532815</basicUdiDi>
    <tradeName>DEMİR KİTİ</tradeName>
    <deviceName>IRON REAGENT</deviceName>
    <manufacturerName>ARCHEM SAĞLIK SANAYİ VE TİCARET ANONİM ŞİRKETİ</manufacturerName>
    <manufacturerSrn>TR-MF-000027166</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010216</emdnCode>
    <emdnDescription>IRON (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>08V6430</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-08T15:42:09.668Z</lastUpdated>
  </row>
  <row>
    <udiDi>08681812532808</udiDi>
    <basicUdiDi>B-08681812532808</basicUdiDi>
    <tradeName>CK-NAC KİTİ</tradeName>
    <deviceName>CK-NAC REAGENT</deviceName>
    <manufacturerName>ARCHEM SAĞLIK SANAYİ VE TİCARET ANONİM ŞİRKETİ</manufacturerName>
    <manufacturerSrn>TR-MF-000027166</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010115</emdnCode>
    <emdnDescription>CREATINE KINASE ISOENZYMES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>08V3520</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-08T15:42:09.286Z</lastUpdated>
  </row>
</eudamedExport>