<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>04050598167506</udiDi>
    <basicUdiDi>B-04050598167506</basicUdiDi>
    <tradeName>IDK® α1-Antitrypsin ELISA</tradeName>
    <deviceName>IDK® α1-Antitrypsin ELISA</deviceName>
    <manufacturerName>Immundiagnostik AG</manufacturerName>
    <manufacturerSrn>DE-MF-000020905</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102019002</emdnCode>
    <emdnDescription>A1-ANTITRYPSIN (PROTEASE INHIBITOR)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>K 6750</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T12:25:37.162Z</lastUpdated>
  </row>
  <row>
    <udiDi>04050598167520</udiDi>
    <basicUdiDi>B-04050598167520</basicUdiDi>
    <tradeName>IDK® α1-Antitrypsin Clearance ELISA</tradeName>
    <deviceName>IDK® α1-Antitrypsin Clearance ELISA</deviceName>
    <manufacturerName>Immundiagnostik AG</manufacturerName>
    <manufacturerSrn>DE-MF-000020905</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102019002</emdnCode>
    <emdnDescription>A1-ANTITRYPSIN (PROTEASE INHIBITOR)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>K 6752</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T12:25:37.131Z</lastUpdated>
  </row>
  <row>
    <udiDi>15099590224042</udiDi>
    <basicUdiDi>150995901447740LL</basicUdiDi>
    <tradeName>IMMAGE Immunochemistry Systems AAT Alpha-1-Antitrypsin Reagent</tradeName>
    <deviceName>IMMAGE Immunochemistry Systems AAT Alpha-1-Antitrypsin Reagent</deviceName>
    <manufacturerName>Beckman Coulter Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010288</manufacturerSrn>
    <authorisedRepresentativeName>Beckman Coulter Ireland Inc.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000886</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102019002</emdnCode>
    <emdnDescription>A1-ANTITRYPSIN (PROTEASE INHIBITOR)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>447740</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-30T17:33:29.210Z</lastUpdated>
  </row>
  <row>
    <udiDi>08431673939946</udiDi>
    <basicUdiDi>B-08431673939946</basicUdiDi>
    <tradeName>α1-ATRYP</tradeName>
    <deviceName>α1-antitrypsin</deviceName>
    <manufacturerName>Spinreact S.A.U.</manufacturerName>
    <manufacturerSrn>ES-MF-000011023</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102019002</emdnCode>
    <emdnDescription>A1-ANTITRYPSIN (PROTEASE INHIBITOR)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MD1102054</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-23T21:26:12.223Z</lastUpdated>
  </row>
  <row>
    <udiDi>08431673320546</udiDi>
    <basicUdiDi>B-08431673320546</basicUdiDi>
    <tradeName>α1-ATRYP</tradeName>
    <deviceName>α1-antitrypsin</deviceName>
    <manufacturerName>Spinreact S.A.U.</manufacturerName>
    <manufacturerSrn>ES-MF-000011023</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102019002</emdnCode>
    <emdnDescription>A1-ANTITRYPSIN (PROTEASE INHIBITOR)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TK1102054</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-23T21:22:31.560Z</lastUpdated>
  </row>
  <row>
    <udiDi>08431673120559</udiDi>
    <basicUdiDi>B-08431673120559</basicUdiDi>
    <tradeName>α1-ATRYP</tradeName>
    <deviceName>α1-antitrypsin</deviceName>
    <manufacturerName>Spinreact S.A.U.</manufacturerName>
    <manufacturerSrn>ES-MF-000011023</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102019002</emdnCode>
    <emdnDescription>A1-ANTITRYPSIN (PROTEASE INHIBITOR)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SP1102054</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-23T21:20:57.013Z</lastUpdated>
  </row>
  <row>
    <udiDi>08431673120542</udiDi>
    <basicUdiDi>B-08431673120542</basicUdiDi>
    <tradeName>α1-ATRYP</tradeName>
    <deviceName>α1-antitrypsin</deviceName>
    <manufacturerName>Spinreact S.A.U.</manufacturerName>
    <manufacturerSrn>ES-MF-000011023</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102019002</emdnCode>
    <emdnDescription>A1-ANTITRYPSIN (PROTEASE INHIBITOR)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1102054</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-23T21:20:56.229Z</lastUpdated>
  </row>
  <row>
    <udiDi>08431673090388</udiDi>
    <basicUdiDi>B-08431673090388</basicUdiDi>
    <tradeName>α1-ATRYP</tradeName>
    <deviceName>α1-antitrypsin</deviceName>
    <manufacturerName>Spinreact S.A.U.</manufacturerName>
    <manufacturerSrn>ES-MF-000011023</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102019002</emdnCode>
    <emdnDescription>A1-ANTITRYPSIN (PROTEASE INHIBITOR)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MX1102054</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-23T21:19:40.935Z</lastUpdated>
  </row>
  <row>
    <udiDi>08431673074784</udiDi>
    <basicUdiDi>B-08431673074784</basicUdiDi>
    <tradeName>α1-ATRYP</tradeName>
    <deviceName>α1-antitrypsin</deviceName>
    <manufacturerName>Spinreact S.A.U.</manufacturerName>
    <manufacturerSrn>ES-MF-000011023</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102019002</emdnCode>
    <emdnDescription>A1-ANTITRYPSIN (PROTEASE INHIBITOR)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MI1102054</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-23T21:15:54.953Z</lastUpdated>
  </row>
  <row>
    <udiDi>00842768009921</udiDi>
    <basicUdiDi>0405686901975WN</basicUdiDi>
    <tradeName>N Antiserum to Human a1-Antitrypsin</tradeName>
    <deviceName>IVDR_27_MAR EB_B_REAG_N_AS_a1-AT</deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Products GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005039</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102019002</emdnCode>
    <emdnDescription>A1-ANTITRYPSIN (PROTEASE INHIBITOR)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10446311</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:37:56.332Z</lastUpdated>
  </row>
  <row>
    <udiDi>00630414653310</udiDi>
    <basicUdiDi>0405686902361VL</basicUdiDi>
    <tradeName>Atellica CH Alpha-1-antitrypsin 2 (AAT2)</tradeName>
    <deviceName>IVDR_67_TTN_DUB-C_B_REAG_AAT2</deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000016560</manufacturerSrn>
    <authorisedRepresentativeName>Siemens Healthcare Diagnostics Manufacturing Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006763</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102019002</emdnCode>
    <emdnDescription>A1-ANTITRYPSIN (PROTEASE INHIBITOR)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>11537578</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:37:42.728Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-I0213N9</udiDi>
    <basicUdiDi>B-I0213N9</basicUdiDi>
    <tradeName>α‐1 Antitrypsin</tradeName>
    <deviceName>α‐1 Antitrypsin</deviceName>
    <manufacturerName>C.P.M. COMPAGNIA PER LA MEDICINA S.R.L.</manufacturerName>
    <manufacturerSrn>IT-MF-000010738</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102019002</emdnCode>
    <emdnDescription>A1-ANTITRYPSIN (PROTEASE INHIBITOR)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>I0213</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-13T22:02:35.102Z</lastUpdated>
  </row>
  <row>
    <udiDi>86060313275090</udiDi>
    <basicUdiDi>B-86060313275090</basicUdiDi>
    <tradeName>α1-Antitrypsin</tradeName>
    <deviceName>α1-Antitrypsin</deviceName>
    <manufacturerName>NEOMEDICA DOO NIŠ</manufacturerName>
    <manufacturerSrn>RS-MF-000021305</manufacturerSrn>
    <authorisedRepresentativeName>Wellkang Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>XI-AR-000001836</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102019002</emdnCode>
    <emdnDescription>A1-ANTITRYPSIN (PROTEASE INHIBITOR)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C1821ATR</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-12T07:14:58.679Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-447740QP</udiDi>
    <basicUdiDi>B-447740QP</basicUdiDi>
    <tradeName>IMMAGE Immunochemistry Systems AAT Alpha-1-Antitrypsin Reagent</tradeName>
    <deviceName>IMMAGE Immunochemistry Systems AAT Alpha-1-Antitrypsin Reagent</deviceName>
    <manufacturerName>Beckman Coulter Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010288</manufacturerSrn>
    <authorisedRepresentativeName>Beckman Coulter Ireland Inc.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000886</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102019002</emdnCode>
    <emdnDescription>A1-ANTITRYPSIN (PROTEASE INHIBITOR)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>447740</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T16:47:55.859Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-149H60TSC7W</udiDi>
    <basicUdiDi>B-149H60TSC7W</basicUdiDi>
    <tradeName>Alpha-1-Antitrypsin (AAT) Assay Kit (Immunoturbidimetric Method)</tradeName>
    <deviceName>Alpha-1-Antitrypsin (AAT) Assay Kit (Immunoturbidimetric Method)</deviceName>
    <manufacturerName>YHLO BIOTECH (NANJING) CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000050474</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102019002</emdnCode>
    <emdnDescription>A1-ANTITRYPSIN (PROTEASE INHIBITOR)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>149H60TSC</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-11T05:27:56.331Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-149H200TSCNK</udiDi>
    <basicUdiDi>B-149H200TSCNK</basicUdiDi>
    <tradeName>Alpha-1-Antitrypsin (AAT) Assay Kit (Immunoturbidimetric Method)</tradeName>
    <deviceName>Alpha-1-Antitrypsin (AAT) Assay Kit (Immunoturbidimetric Method)</deviceName>
    <manufacturerName>YHLO BIOTECH (NANJING) CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000050474</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102019002</emdnCode>
    <emdnDescription>A1-ANTITRYPSIN (PROTEASE INHIBITOR)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>149H200TSC</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-11T05:27:55.535Z</lastUpdated>
  </row>
  <row>
    <udiDi>08053172971816</udiDi>
    <basicUdiDi>B-08053172971816</basicUdiDi>
    <tradeName>ALPHA 1- ANTITRYPSIN</tradeName>
    <deviceName>ALPHA 1-ANTITRYPSIN</deviceName>
    <manufacturerName>GIESSE DIAGNOSTICS SRL</manufacturerName>
    <manufacturerSrn>IT-MF-000039031</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102019002</emdnCode>
    <emdnDescription>A1-ANTITRYPSIN (PROTEASE INHIBITOR)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6702</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-07T16:47:30.236Z</lastUpdated>
  </row>
  <row>
    <udiDi>06971674868583</udiDi>
    <basicUdiDi>B-06971674868583</basicUdiDi>
    <tradeName>α1-antitrypsin (AAT) Test Kit (Immunoturbidimetric)</tradeName>
    <deviceName>α1-antitrypsin (AAT) Test Kit (Immunoturbidimetric)</deviceName>
    <manufacturerName>Biobase Biodustry(Shandong) Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025015</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005110</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102019002</emdnCode>
    <emdnDescription>A1-ANTITRYPSIN (PROTEASE INHIBITOR)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Quality Control：1mL×1(92060)</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T10:39:59.892Z</lastUpdated>
  </row>
  <row>
    <udiDi>06971225933036</udiDi>
    <basicUdiDi>B-06971225933036</basicUdiDi>
    <tradeName>Nephstar AAT Kit</tradeName>
    <deviceName>Nephstar AAT Kit</deviceName>
    <manufacturerName>Goldsite Diagnostics Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000001353</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102019002</emdnCode>
    <emdnDescription>A1-ANTITRYPSIN (PROTEASE INHIBITOR)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DK038</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-06T09:26:32.722Z</lastUpdated>
  </row>
  <row>
    <udiDi>06971225930745</udiDi>
    <basicUdiDi>B-06971225930745</basicUdiDi>
    <tradeName>Omlipo AAT Kit</tradeName>
    <deviceName>Omlipo AAT Kit</deviceName>
    <manufacturerName>Goldsite Diagnostics Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000001353</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102019002</emdnCode>
    <emdnDescription>A1-ANTITRYPSIN (PROTEASE INHIBITOR)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OP38050</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-06T09:22:25.187Z</lastUpdated>
  </row>
</eudamedExport>