<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>06977100860367</udiDi>
    <basicUdiDi>B-06977100860367</basicUdiDi>
    <tradeName>Neurofilament Lightchain Test Kit (Fluorescence Immunochromatography)</tradeName>
    <deviceName>Neurofilament Lightchain Test Kit (Fluorescence Immunochromatography)</deviceName>
    <manufacturerName>Suzhou Astrabio Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000041763</manufacturerSrn>
    <authorisedRepresentativeName>MedPath GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000087</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102019099</emdnCode>
    <emdnDescription>SPECIFIC PROTEINS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>E74043</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-23T20:54:53.417Z</lastUpdated>
  </row>
  <row>
    <udiDi>06977100860350</udiDi>
    <basicUdiDi>B-06977100860350</basicUdiDi>
    <tradeName>Neurofilament Lightchain Test Kit (Fluorescence Immunochromatography)</tradeName>
    <deviceName>Neurofilament Lightchain Test Kit (Fluorescence Immunochromatography)</deviceName>
    <manufacturerName>Suzhou Astrabio Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000041763</manufacturerSrn>
    <authorisedRepresentativeName>MedPath GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000087</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102019099</emdnCode>
    <emdnDescription>SPECIFIC PROTEINS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>E74044</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-23T20:54:52.612Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936895315773</udiDi>
    <basicUdiDi>B-06936895315773</basicUdiDi>
    <tradeName>Adenosine Deaminase (ADA) Test Kit (Enzymatic)</tradeName>
    <deviceName>Adenosine Deaminase (ADA) Test Kit (Enzymatic)</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>W0102019010</emdnCode>
    <emdnDescription>ADENOSINE DEAMINASE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R1:40mL×2  R2:20mL×2（794）</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-23T20:49:58.593Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936895305637</udiDi>
    <basicUdiDi>B-06936895305637</basicUdiDi>
    <tradeName>Adenosine Deaminase (ADA) Test Kit (Enzymatic)</tradeName>
    <deviceName>Adenosine Deaminase (ADA) Test Kit (Enzymatic)</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>W0102019010</emdnCode>
    <emdnDescription>ADENOSINE DEAMINASE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R1:60ml×5   R2:50ml×3（795）</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-23T20:49:57.782Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936895305620</udiDi>
    <basicUdiDi>B-06936895305620</basicUdiDi>
    <tradeName>Adenosine Deaminase (ADA) Test Kit (Enzymatic)</tradeName>
    <deviceName>Adenosine Deaminase (ADA) Test Kit (Enzymatic)</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>W0102019010</emdnCode>
    <emdnDescription>ADENOSINE DEAMINASE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R1:100ml×1  R2:50ml×1（708）</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-23T20:49:53.782Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936895305613</udiDi>
    <basicUdiDi>B-06936895305613</basicUdiDi>
    <tradeName>Adenosine Deaminase (ADA) Test Kit (Enzymatic)</tradeName>
    <deviceName>Adenosine Deaminase (ADA) Test Kit (Enzymatic)</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>W0102019010</emdnCode>
    <emdnDescription>ADENOSINE DEAMINASE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R1:20mL×4  R2:10mL×4（707）</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-23T20:49:52.984Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936895305606</udiDi>
    <basicUdiDi>B-06936895305606</basicUdiDi>
    <tradeName>Adenosine Deaminase (ADA) Test Kit (Enzymatic)</tradeName>
    <deviceName>Adenosine Deaminase (ADA) Test Kit (Enzymatic)</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>W0102019010</emdnCode>
    <emdnDescription>ADENOSINE DEAMINASE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R1:20mL×4  R2:10mL×4（796）</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-23T20:49:52.185Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936895305590</udiDi>
    <basicUdiDi>B-06936895305590</basicUdiDi>
    <tradeName>Adenosine Deaminase (ADA) Test Kit (Enzymatic)</tradeName>
    <deviceName>Adenosine Deaminase (ADA) Test Kit (Enzymatic)</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>W0102019010</emdnCode>
    <emdnDescription>ADENOSINE DEAMINASE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R1:20mL×4  R2:10mL×4（710）</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-23T20:49:51.379Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936895305583</udiDi>
    <basicUdiDi>B-06936895305583</basicUdiDi>
    <tradeName>Adenosine Deaminase (ADA) Test Kit (Enzymatic)</tradeName>
    <deviceName>Adenosine Deaminase (ADA) Test Kit (Enzymatic)</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>W0102019010</emdnCode>
    <emdnDescription>ADENOSINE DEAMINASE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R1:50mL×2  R2:25mL×2（716）</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-23T20:49:47.379Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936895305576</udiDi>
    <basicUdiDi>B-06936895305576</basicUdiDi>
    <tradeName>Adenosine Deaminase (ADA) Test Kit (Enzymatic)</tradeName>
    <deviceName>Adenosine Deaminase (ADA) Test Kit (Enzymatic)</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>W0102019010</emdnCode>
    <emdnDescription>ADENOSINE DEAMINASE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R1:50mL×2  R2:25mL×2（798）</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-23T20:49:46.581Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936895305569</udiDi>
    <basicUdiDi>B-06936895305569</basicUdiDi>
    <tradeName>Adenosine Deaminase (ADA) Test Kit (Enzymatic)</tradeName>
    <deviceName>Adenosine Deaminase (ADA) Test Kit (Enzymatic)</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>W0102019010</emdnCode>
    <emdnDescription>ADENOSINE DEAMINASE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R1:50mL×2  R2:25mL×2（715）</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-23T20:49:45.786Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936895305552</udiDi>
    <basicUdiDi>B-06936895305552</basicUdiDi>
    <tradeName>Adenosine Deaminase (ADA) Test Kit (Enzymatic)</tradeName>
    <deviceName>Adenosine Deaminase (ADA) Test Kit (Enzymatic)</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>W0102019010</emdnCode>
    <emdnDescription>ADENOSINE DEAMINASE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R1:50mL×2  R2:25mL×2（705）</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-23T20:49:44.980Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936895305545</udiDi>
    <basicUdiDi>B-06936895305545</basicUdiDi>
    <tradeName>Adenosine Deaminase (ADA) Test Kit (Enzymatic)</tradeName>
    <deviceName>Adenosine Deaminase (ADA) Test Kit (Enzymatic)</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>W0102019010</emdnCode>
    <emdnDescription>ADENOSINE DEAMINASE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R1:50ml×2    R2:50ml×1（793）</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-23T20:49:40.977Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936895305538</udiDi>
    <basicUdiDi>B-06936895305538</basicUdiDi>
    <tradeName>Adenosine Deaminase (ADA) Test Kit (Enzymatic)</tradeName>
    <deviceName>Adenosine Deaminase (ADA) Test Kit (Enzymatic)</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>W0102019010</emdnCode>
    <emdnDescription>ADENOSINE DEAMINASE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R1:40ml×2    R2:40ml×1（792）</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-23T20:49:40.185Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936895305521</udiDi>
    <basicUdiDi>B-06936895305521</basicUdiDi>
    <tradeName>Adenosine Deaminase (ADA) Test Kit (Enzymatic)</tradeName>
    <deviceName>Adenosine Deaminase (ADA) Test Kit (Enzymatic)</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>W0102019010</emdnCode>
    <emdnDescription>ADENOSINE DEAMINASE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R1:40mL×2  R2:20mL×2（791）</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-23T20:49:39.371Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936895305514</udiDi>
    <basicUdiDi>B-06936895305514</basicUdiDi>
    <tradeName>Adenosine Deaminase (ADA) Test Kit (Enzymatic)</tradeName>
    <deviceName>Adenosine Deaminase (ADA) Test Kit (Enzymatic)</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>W0102019010</emdnCode>
    <emdnDescription>ADENOSINE DEAMINASE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R1:40mL×2  R2:20mL×2（706）</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-23T20:49:38.574Z</lastUpdated>
  </row>
  <row>
    <udiDi>06936895305507</udiDi>
    <basicUdiDi>B-06936895305507</basicUdiDi>
    <tradeName>Adenosine Deaminase (ADA) Test Kit (Enzymatic)</tradeName>
    <deviceName>Adenosine Deaminase (ADA) Test Kit  (Enzymatic)</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>W0102019010</emdnCode>
    <emdnDescription>ADENOSINE DEAMINASE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R1:20mL×1  R2:10mL×1（703）</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-23T20:49:34.568Z</lastUpdated>
  </row>
  <row>
    <udiDi>00630414954271</udiDi>
    <basicUdiDi>0405686901352VC</basicUdiDi>
    <tradeName>IMMULITE 2000 TBG Sample Diluent</tradeName>
    <deviceName>IVDR_67_LLB_DUB-C_A_REAG_TBG Sample Diluent</deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Products Ltd.</manufacturerName>
    <manufacturerSrn>GB-MF-000016339</manufacturerSrn>
    <authorisedRepresentativeName>Siemens Healthcare Diagnostics Manufacturing Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006763</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102010114</emdnCode>
    <emdnDescription>BUFFERS (UNASSIGNABLE), SUPPLEM. REAGENTS, ETC (IG'S)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10387072</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-23T19:42:20.281Z</lastUpdated>
  </row>
  <row>
    <udiDi>00630414596297</udiDi>
    <basicUdiDi>0405686901786WH</basicUdiDi>
    <tradeName>Atellica CH Transferrin (Trf)</tradeName>
    <deviceName>IVDR_67_TTN_DUB-C_B_REAG_Transferrin</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>W0102010307</emdnCode>
    <emdnDescription>TRANSFERRIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>11097613</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-23T19:41:39.434Z</lastUpdated>
  </row>
  <row>
    <udiDi>00630414596266</udiDi>
    <basicUdiDi>0405686901728W3</basicUdiDi>
    <tradeName>Atellica CH Immunoglobulin G_2 (IgG_2)</tradeName>
    <deviceName>IVDR_67_TTN_DUB-C_B_REAG_IGG_2</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>W0102010105</emdnCode>
    <emdnDescription>IMMUNOGLOBULIN G</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>11097616</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-23T19:41:35.413Z</lastUpdated>
  </row>
</eudamedExport>