<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>08681812532488</udiDi>
    <basicUdiDi>B-08681812532488</basicUdiDi>
    <tradeName>ÜRİK ASİT KİTİ</tradeName>
    <deviceName>URIC ACID 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>W01010232</emdnCode>
    <emdnDescription>URIC ACID</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>08V6220</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-08T15:42:08.749Z</lastUpdated>
  </row>
  <row>
    <udiDi>08681812532471</udiDi>
    <basicUdiDi>B-08681812532471</basicUdiDi>
    <tradeName>ÜRİK ASİT KİTİ</tradeName>
    <deviceName>URIC ACID 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>W01010232</emdnCode>
    <emdnDescription>URIC ACID</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>08V6225</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-08T15:42:08.575Z</lastUpdated>
  </row>
  <row>
    <udiDi>08681812532464</udiDi>
    <basicUdiDi>B-08681812532464</basicUdiDi>
    <tradeName>MİKROALBÜMİN KİTİ</tradeName>
    <deviceName>MICROALBUMIN 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>W0102010309</emdnCode>
    <emdnDescription>ALBUMIN (IC) INCL. UALBUMIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>08V6025</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-08T15:42:03.171Z</lastUpdated>
  </row>
  <row>
    <udiDi>08681812532457</udiDi>
    <basicUdiDi>B-08681812532457</basicUdiDi>
    <tradeName>MAGNEZYUM KİTİ</tradeName>
    <deviceName>MAGNESIUM 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>W01010306</emdnCode>
    <emdnDescription>MAGNESIUM</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>08V5920</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-08T15:42:02.584Z</lastUpdated>
  </row>
  <row>
    <udiDi>08681812532440</udiDi>
    <basicUdiDi>B-08681812532440</basicUdiDi>
    <tradeName>MAGNEZYUM KİTİ</tradeName>
    <deviceName>MAGNESIUM 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>W01010306</emdnCode>
    <emdnDescription>MAGNESIUM</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>08V5925</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-08T15:42:01.589Z</lastUpdated>
  </row>
  <row>
    <udiDi>08681812532433</udiDi>
    <basicUdiDi>B-08681812532433</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>08V4720</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-08T15:42:00.774Z</lastUpdated>
  </row>
  <row>
    <udiDi>08681812532426</udiDi>
    <basicUdiDi>B-08681812532426</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>08V4725</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-08T15:41:56.772Z</lastUpdated>
  </row>
  <row>
    <udiDi>08681812532419</udiDi>
    <basicUdiDi>B-08681812532419</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>08V4225</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-08T15:41:55.971Z</lastUpdated>
  </row>
  <row>
    <udiDi>08681812532402</udiDi>
    <basicUdiDi>B-08681812532402</basicUdiDi>
    <tradeName>D-DİMER KİTİ</tradeName>
    <deviceName>D-DIMER 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>W01021199</emdnCode>
    <emdnDescription>RHEUMATOID / INFLAMMATORY DISEASE MARKERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>08V4025</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-08T15:41:55.173Z</lastUpdated>
  </row>
  <row>
    <udiDi>08681812532396</udiDi>
    <basicUdiDi>B-08681812532396</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>08V3725</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-08T15:41:54.371Z</lastUpdated>
  </row>
  <row>
    <udiDi>08681812532389</udiDi>
    <basicUdiDi>B-08681812532389</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>08V3525</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-08T15:41:50.366Z</lastUpdated>
  </row>
  <row>
    <udiDi>08681812530903</udiDi>
    <basicUdiDi>B-08681812530903</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>08V5720</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-08T15:41:49.561Z</lastUpdated>
  </row>
  <row>
    <udiDi>08681812530897</udiDi>
    <basicUdiDi>B-08681812530897</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>08V5725</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-08T15:41:48.760Z</lastUpdated>
  </row>
  <row>
    <udiDi>08681812530880</udiDi>
    <basicUdiDi>B-08681812530880</basicUdiDi>
    <tradeName>TRİGLİSERİT KİTİ</tradeName>
    <deviceName>TRIGLYCERIDES 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>W01010231</emdnCode>
    <emdnDescription>TRIGLYCERIDES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>08V5520</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-08T15:41:47.960Z</lastUpdated>
  </row>
  <row>
    <udiDi>08681812530873</udiDi>
    <basicUdiDi>B-08681812530873</basicUdiDi>
    <tradeName>TRİGLİSERİT KİTİ</tradeName>
    <deviceName>TRIGLYCERIDES 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>W01010231</emdnCode>
    <emdnDescription>TRIGLYCERIDES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>08V5525</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-08T15:41:43.977Z</lastUpdated>
  </row>
  <row>
    <udiDi>08681812530866</udiDi>
    <basicUdiDi>B-08681812530866</basicUdiDi>
    <tradeName>LİPAZ KİTİ</tradeName>
    <deviceName>LIPASE 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>W01010123</emdnCode>
    <emdnDescription>LIPASE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>08V5120</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-08T15:41:43.774Z</lastUpdated>
  </row>
  <row>
    <udiDi>08681812530859</udiDi>
    <basicUdiDi>B-08681812530859</basicUdiDi>
    <tradeName>LİPAZ KİTİ</tradeName>
    <deviceName>LIPASE 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>W01010123</emdnCode>
    <emdnDescription>LIPASE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>08V5125</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-08T15:41:43.768Z</lastUpdated>
  </row>
  <row>
    <udiDi>08681812530842</udiDi>
    <basicUdiDi>B-08681812530842</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>08V3720</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-08T15:41:43.719Z</lastUpdated>
  </row>
  <row>
    <udiDi>08681812530767</udiDi>
    <basicUdiDi>B-08681812530767</basicUdiDi>
    <tradeName>D-DİMER KİTİ</tradeName>
    <deviceName>D-DIMER 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>W01021199</emdnCode>
    <emdnDescription>RHEUMATOID / INFLAMMATORY DISEASE MARKERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>08V4020</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-08T15:41:37.554Z</lastUpdated>
  </row>
  <row>
    <udiDi>08681812530743</udiDi>
    <basicUdiDi>B-08681812530743</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>08V3320</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-08T15:41:36.760Z</lastUpdated>
  </row>
</eudamedExport>