<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
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    <udiDi>08681812530699</udiDi>
    <basicUdiDi>B-08681812530699</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>08V4230</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-20T07:07:45.617Z</lastUpdated>
  </row>
  <row>
    <udiDi>08681812505956</udiDi>
    <basicUdiDi>B-08681812505956</basicUdiDi>
    <tradeName>ALBUMİN  KİTİ</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ARCHEM SAĞLIK SANAYİ VE TİCARET ANONİM ŞİRKETİ</manufacturerName>
    <manufacturerSrn>TR-MF-000027166</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>ALBUMIN (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BY2010</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-20T07:07:23.713Z</lastUpdated>
  </row>
  <row>
    <udiDi>08681812525091</udiDi>
    <basicUdiDi>86818125HD099KU</basicUdiDi>
    <tradeName>DS DILUENT</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ARCHEM SAĞLIK SANAYİ VE TİCARET ANONİM ŞİRKETİ</manufacturerName>
    <manufacturerSrn>TR-MF-000027166</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5950MN</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-20T07:07:12.131Z</lastUpdated>
  </row>
  <row>
    <udiDi>08681812525978</udiDi>
    <basicUdiDi>B-08681812525978</basicUdiDi>
    <tradeName>ALBÜMİN  KİTİ</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ARCHEM SAĞLIK SANAYİ VE TİCARET ANONİM ŞİRKETİ</manufacturerName>
    <manufacturerSrn>TR-MF-000027166</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>ALBUMIN (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A2014N</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-20T07:07:11.922Z</lastUpdated>
  </row>
  <row>
    <udiDi>08681812530521</udiDi>
    <basicUdiDi>86818125HD001JH</basicUdiDi>
    <tradeName>CH Reaktif Prob Temizleyici 1 (RPC1)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ARCHEM SAĞLIK SANAYİ VE TİCARET ANONİM ŞİRKETİ</manufacturerName>
    <manufacturerSrn>TR-MF-000027166</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AT5001</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-20T07:07:11.688Z</lastUpdated>
  </row>
  <row>
    <udiDi>08699015289535</udiDi>
    <basicUdiDi>B-08699015289535</basicUdiDi>
    <tradeName>HBA1C II DİREKT KİTİ</tradeName>
    <deviceName>HBA1C II 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>06R72-30</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-09T13:13:02.929Z</lastUpdated>
  </row>
  <row>
    <udiDi>08699015289528</udiDi>
    <basicUdiDi>B-08699015289528</basicUdiDi>
    <tradeName>HBA1C II DİREKT KİTİ</tradeName>
    <deviceName>HBA1C II 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>06R72-20</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-09T13:13:01.291Z</lastUpdated>
  </row>
  <row>
    <udiDi>08699015281850</udiDi>
    <basicUdiDi>B-08699015281850</basicUdiDi>
    <tradeName>IGE TÜRBİDİMETRİK KALİBRATÖR SET</tradeName>
    <deviceName>IGE TURBIDIMETRIC CALIBRATOR SET</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>01R99-01</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-09T13:13:00.504Z</lastUpdated>
  </row>
  <row>
    <udiDi>08699015281843</udiDi>
    <basicUdiDi>B-08699015281843</basicUdiDi>
    <tradeName>IGE TÜRBİDİMETRİK KONTROL SET</tradeName>
    <deviceName>IGE TURBIDIMETRIC CONTROL SET</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>W0101050299</emdnCode>
    <emdnDescription>SPECIFIC CONTROLS (CC) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>01R98-01</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-09T13:12:58.891Z</lastUpdated>
  </row>
  <row>
    <udiDi>08699015281836</udiDi>
    <basicUdiDi>B-08699015281836</basicUdiDi>
    <tradeName>HBA1C KALİBRATÖR SET</tradeName>
    <deviceName>HBA1C CALIBRATOR SET</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>01R97-01</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-09T13:12:56.503Z</lastUpdated>
  </row>
  <row>
    <udiDi>08699015281829</udiDi>
    <basicUdiDi>B-08699015281829</basicUdiDi>
    <tradeName>HBA1C KONTROL SET</tradeName>
    <deviceName>HBA1C CONTROL SET</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>W0101050205</emdnCode>
    <emdnDescription>DIABETES CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>01R96-01</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-09T13:12:54.898Z</lastUpdated>
  </row>
  <row>
    <udiDi>08699015281812</udiDi>
    <basicUdiDi>B-08699015281812</basicUdiDi>
    <tradeName>HDL-LDL KALİBRATÖR (ARCAL LİPİT)</tradeName>
    <deviceName>HDL-LDL CALIBRATOR ( ARCAL LIPID)</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>W0101050101</emdnCode>
    <emdnDescription>ASSAYED MULTICOMPONENT CONTROLS (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>01R95-01</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-09T13:12:54.098Z</lastUpdated>
  </row>
  <row>
    <udiDi>08699015281805</udiDi>
    <basicUdiDi>B-08699015281805</basicUdiDi>
    <tradeName>CK-MB KALİBRATÖR</tradeName>
    <deviceName>CK-MB 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>01R94-01</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-09T13:12:52.490Z</lastUpdated>
  </row>
  <row>
    <udiDi>08699015281775</udiDi>
    <basicUdiDi>B-08699015281775</basicUdiDi>
    <tradeName>CRP WR KALİBRATÖR</tradeName>
    <deviceName>CRP WR 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>W0102152203</emdnCode>
    <emdnDescription>SPECIFIC PROTEIN STANDARDS AND CALIBRATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>01R91-01</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-09T13:12:50.085Z</lastUpdated>
  </row>
  <row>
    <udiDi>08699015281799</udiDi>
    <basicUdiDi>B-08699015281799</basicUdiDi>
    <tradeName>CK-MB KONTROL SEVİYE II</tradeName>
    <deviceName>CK-MB CONTROL LEVEL II</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>W0101050201</emdnCode>
    <emdnDescription>ENZYME CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>01R93-01</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-09T13:12:48.494Z</lastUpdated>
  </row>
  <row>
    <udiDi>08699015281782</udiDi>
    <basicUdiDi>B-08699015281782</basicUdiDi>
    <tradeName>CK-MB KONTROL SEVİYE I</tradeName>
    <deviceName>CK-MB CONTROL LEVEL I</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>W0101050201</emdnCode>
    <emdnDescription>ENZYME CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>01R92-01</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-09T13:12:47.687Z</lastUpdated>
  </row>
  <row>
    <udiDi>08699015281768</udiDi>
    <basicUdiDi>B-08699015281768</basicUdiDi>
    <tradeName>ASO TÜRBİDİMETRİK KALİBRATÖR</tradeName>
    <deviceName>ASO TURBIDIMETRIC 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>01R90-01</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-09T13:12:46.088Z</lastUpdated>
  </row>
  <row>
    <udiDi>08699015281744</udiDi>
    <basicUdiDi>B-08699015281744</basicUdiDi>
    <tradeName>IGE TÜRBİDİMETRİK KİTİ</tradeName>
    <deviceName>IGE 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>W01020201</emdnCode>
    <emdnDescription>IMMUNOGLOBULIN E - TOTAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>01R89-31</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-09T13:12:30.829Z</lastUpdated>
  </row>
  <row>
    <udiDi>08699015281737</udiDi>
    <basicUdiDi>B-08699015281737</basicUdiDi>
    <tradeName>IGE TÜRBİDİMETRİK KİTİ</tradeName>
    <deviceName>IGE 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>W01020201</emdnCode>
    <emdnDescription>IMMUNOGLOBULIN E - TOTAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>01R89-41</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-09T13:12:30.024Z</lastUpdated>
  </row>
  <row>
    <udiDi>08699015281720</udiDi>
    <basicUdiDi>B-08699015281720</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>01R88-21</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-09T13:12:29.227Z</lastUpdated>
  </row>
</eudamedExport>