<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>06978139075807</udiDi>
    <basicUdiDi>B-06978139075807</basicUdiDi>
    <tradeName>Creatine Kinase MB (CK-MB) Assay Kits (Lateral Flow Immunoassay)</tradeName>
    <deviceName>Creatine Kinase MB (CK-MB) Assay Kits (Lateral Flow Immunoassay)</deviceName>
    <manufacturerName>Shenzhen Lifotronic Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005654</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021311</emdnCode>
    <emdnDescription>CREATINE KINASE - MB MASS (IC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>745009</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:40:08.301Z</lastUpdated>
  </row>
  <row>
    <udiDi>06978139075791</udiDi>
    <basicUdiDi>B-06978139075791</basicUdiDi>
    <tradeName>Microalbumin (mAlb) Assay Kits (Lateral Flow Immunoassay)</tradeName>
    <deviceName>Microalbumin (mAlb) Assay Kits (Lateral Flow Immunoassay)</deviceName>
    <manufacturerName>Shenzhen Lifotronic Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005654</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102160101</emdnCode>
    <emdnDescription>ALBUMIN INCL. UALBUMIN RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>745006</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:40:07.501Z</lastUpdated>
  </row>
  <row>
    <udiDi>06978139075784</udiDi>
    <basicUdiDi>B-06978139075784</basicUdiDi>
    <tradeName>Cardiac Troponin (cTnI) Assay Kits (Lateral Flow Immunoassay)</tradeName>
    <deviceName>Cardiac Troponin (cTnI) Assay Kits (Lateral Flow Immunoassay)</deviceName>
    <manufacturerName>Shenzhen Lifotronic Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005654</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021306</emdnCode>
    <emdnDescription>TROPONIN I/T</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>745005</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:40:05.901Z</lastUpdated>
  </row>
  <row>
    <udiDi>06978139075777</udiDi>
    <basicUdiDi>B-06978139075777</basicUdiDi>
    <tradeName>N-terminal Pro-Brain Natriuretic Peptide (NT-proBNP) Assay Kits (Lateral Flow Immunoassay)</tradeName>
    <deviceName>N-terminal Pro-Brain Natriuretic Peptide (NT-proBNP) Assay Kits (Lateral Flow Immunoassay)</deviceName>
    <manufacturerName>Shenzhen Lifotronic Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005654</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021301</emdnCode>
    <emdnDescription>BNP / PROBNP (INCLUDING OTHER NATRIURIC PEPTIDES)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>745004</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:40:03.500Z</lastUpdated>
  </row>
  <row>
    <udiDi>06978139075760</udiDi>
    <basicUdiDi>B-06978139075760</basicUdiDi>
    <tradeName>Hypersensitivity C-reactive Protein (hs-CRP) Assay Kits (Lateral Flow Immunoassay)</tradeName>
    <deviceName>Hypersensitivity C-reactive Protein (hs-CRP) Assay Kits (Lateral Flow Immunoassay)</deviceName>
    <manufacturerName>Shenzhen Lifotronic Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005654</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021109</emdnCode>
    <emdnDescription>C-REACTIVE PROTEIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>745002</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:40:01.893Z</lastUpdated>
  </row>
  <row>
    <udiDi>06978139075746</udiDi>
    <basicUdiDi>B-06978139075746</basicUdiDi>
    <tradeName>DHEA-S (eCLIA)</tradeName>
    <deviceName>DHEA-S (eCLIA)</deviceName>
    <manufacturerName>Shenzhen Lifotronic Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005654</manufacturerSrn>
    <authorisedRepresentativeName>Umedwings Netherlands B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000444</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102050102</emdnCode>
    <emdnDescription>DEHYDRO-EPIANDROSTERONE SULPHATE (INCL. DHEA)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0320514901</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:40:01.096Z</lastUpdated>
  </row>
  <row>
    <udiDi>06978139075739</udiDi>
    <basicUdiDi>B-06978139075739</basicUdiDi>
    <tradeName>DHEA-S (eCLIA)</tradeName>
    <deviceName>DHEA-S (eCLIA)</deviceName>
    <manufacturerName>Shenzhen Lifotronic Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005654</manufacturerSrn>
    <authorisedRepresentativeName>Umedwings Netherlands B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000444</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102050102</emdnCode>
    <emdnDescription>DEHYDRO-EPIANDROSTERONE SULPHATE (INCL. DHEA)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0320514902</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:39:59.493Z</lastUpdated>
  </row>
  <row>
    <udiDi>06978139075722</udiDi>
    <basicUdiDi>B-06978139075722</basicUdiDi>
    <tradeName>DHEA-S (eCLIA)</tradeName>
    <deviceName>DHEA-S (eCLIA)</deviceName>
    <manufacturerName>Shenzhen Lifotronic Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005654</manufacturerSrn>
    <authorisedRepresentativeName>Umedwings Netherlands B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000444</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102050102</emdnCode>
    <emdnDescription>DEHYDRO-EPIANDROSTERONE SULPHATE (INCL. DHEA)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0320514903</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:39:57.175Z</lastUpdated>
  </row>
  <row>
    <udiDi>06978139075128</udiDi>
    <basicUdiDi>B-06978139075128</basicUdiDi>
    <tradeName>free TESTO (eCLIA)</tradeName>
    <deviceName>free TESTO (eCLIA)</deviceName>
    <manufacturerName>Shenzhen Lifotronic Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005654</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102050110</emdnCode>
    <emdnDescription>TESTOSTERONE (WITH DEHYDRO AND FREE TESTOSTERONE)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0320514701</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:39:55.488Z</lastUpdated>
  </row>
  <row>
    <udiDi>06978139075111</udiDi>
    <basicUdiDi>B-06978139075111</basicUdiDi>
    <tradeName>free TESTO (eCLIA)</tradeName>
    <deviceName>free TESTO (eCLIA)</deviceName>
    <manufacturerName>Shenzhen Lifotronic Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005654</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102050110</emdnCode>
    <emdnDescription>TESTOSTERONE (WITH DEHYDRO AND FREE TESTOSTERONE)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0320514704</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:39:54.698Z</lastUpdated>
  </row>
  <row>
    <udiDi>06978139075685</udiDi>
    <basicUdiDi>B-06978139075685</basicUdiDi>
    <tradeName>DHEA-S (eCLIA)</tradeName>
    <deviceName>DHEA-S (eCLIA)</deviceName>
    <manufacturerName>Shenzhen Lifotronic Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005654</manufacturerSrn>
    <authorisedRepresentativeName>Umedwings Netherlands B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000444</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102050102</emdnCode>
    <emdnDescription>DEHYDRO-EPIANDROSTERONE SULPHATE (INCL. DHEA)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0320514904</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:39:53.092Z</lastUpdated>
  </row>
  <row>
    <udiDi>06978139075104</udiDi>
    <basicUdiDi>B-06978139075104</basicUdiDi>
    <tradeName>free TESTO (eCLIA)</tradeName>
    <deviceName>free TESTO (eCLIA)</deviceName>
    <manufacturerName>Shenzhen Lifotronic Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005654</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102050110</emdnCode>
    <emdnDescription>TESTOSTERONE (WITH DEHYDRO AND FREE TESTOSTERONE)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0320514703</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:39:50.694Z</lastUpdated>
  </row>
  <row>
    <udiDi>06978139075098</udiDi>
    <basicUdiDi>B-06978139075098</basicUdiDi>
    <tradeName>free TESTO (eCLIA)</tradeName>
    <deviceName>free TESTO (eCLIA)</deviceName>
    <manufacturerName>Shenzhen Lifotronic Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005654</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102050110</emdnCode>
    <emdnDescription>TESTOSTERONE (WITH DEHYDRO AND FREE TESTOSTERONE)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0320514702</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:39:35.445Z</lastUpdated>
  </row>
  <row>
    <udiDi>06978139073698</udiDi>
    <basicUdiDi>B-06978139073698</basicUdiDi>
    <tradeName>Chromatographic Column(HPLC)</tradeName>
    <deviceName>Chromatographic Column(HPLC)</deviceName>
    <manufacturerName>Shenzhen Lifotronic Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005654</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0201050280</emdnCode>
    <emdnDescription>HIGH PERFORMANCE LIQUID CHROMATOGRAPHY SYSTEMS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>032020705</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:39:34.629Z</lastUpdated>
  </row>
  <row>
    <udiDi>06978139073681</udiDi>
    <basicUdiDi>B-06978139073681</basicUdiDi>
    <tradeName>Chromatographic Column(HPLC)</tradeName>
    <deviceName>Chromatographic Column(HPLC)</deviceName>
    <manufacturerName>Shenzhen Lifotronic Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005654</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0201050280</emdnCode>
    <emdnDescription>HIGH PERFORMANCE LIQUID CHROMATOGRAPHY SYSTEMS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>032020704</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:39:33.828Z</lastUpdated>
  </row>
  <row>
    <udiDi>06978139072721</udiDi>
    <basicUdiDi>B-06978139072721</basicUdiDi>
    <tradeName>Hb NEXT analytical column</tradeName>
    <deviceName>Hb NEXT analytical column</deviceName>
    <manufacturerName>Shenzhen Lifotronic Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005654</manufacturerSrn>
    <authorisedRepresentativeName>Umedwings Netherlands B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000444</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0201050280</emdnCode>
    <emdnDescription>HIGH PERFORMANCE LIQUID CHROMATOGRAPHY SYSTEMS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>58643</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:39:33.034Z</lastUpdated>
  </row>
  <row>
    <udiDi>06978139072080</udiDi>
    <basicUdiDi>B-06978139072080</basicUdiDi>
    <tradeName>TNF-alpha (eCLIA)</tradeName>
    <deviceName>TNF-alpha (eCLIA)</deviceName>
    <manufacturerName>Shenzhen Lifotronic Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005654</manufacturerSrn>
    <authorisedRepresentativeName>Umedwings Netherlands B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000444</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01030603</emdnCode>
    <emdnDescription>TUMOUR NECROSIS FACTORS (TNFα,TNFβ, ...)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0320513502</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:39:29.028Z</lastUpdated>
  </row>
  <row>
    <udiDi>06978139072073</udiDi>
    <basicUdiDi>B-06978139072073</basicUdiDi>
    <tradeName>TNF-alpha (eCLIA)</tradeName>
    <deviceName>TNF-alpha (eCLIA)</deviceName>
    <manufacturerName>Shenzhen Lifotronic Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005654</manufacturerSrn>
    <authorisedRepresentativeName>Umedwings Netherlands B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000444</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01030603</emdnCode>
    <emdnDescription>TUMOUR NECROSIS FACTORS (TNFα,TNFβ, ...)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0320513501</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:39:28.226Z</lastUpdated>
  </row>
  <row>
    <udiDi>06978139072066</udiDi>
    <basicUdiDi>B-06978139072066</basicUdiDi>
    <tradeName>TNF-alpha (eCLIA)</tradeName>
    <deviceName>TNF-alpha (eCLIA)</deviceName>
    <manufacturerName>Shenzhen Lifotronic Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005654</manufacturerSrn>
    <authorisedRepresentativeName>Umedwings Netherlands B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000444</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01030603</emdnCode>
    <emdnDescription>TUMOUR NECROSIS FACTORS (TNFα,TNFβ, ...)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0320513504</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:39:27.426Z</lastUpdated>
  </row>
  <row>
    <udiDi>06978139072059</udiDi>
    <basicUdiDi>B-06978139072059</basicUdiDi>
    <tradeName>TNF-alpha (eCLIA)</tradeName>
    <deviceName>TNF-alpha (eCLIA)</deviceName>
    <manufacturerName>Shenzhen Lifotronic Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005654</manufacturerSrn>
    <authorisedRepresentativeName>Umedwings Netherlands B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000444</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01030603</emdnCode>
    <emdnDescription>TUMOUR NECROSIS FACTORS (TNFα,TNFβ, ...)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0320513503</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:39:26.626Z</lastUpdated>
  </row>
</eudamedExport>