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    <basicUdiDi>B-06975491761003</basicUdiDi>
    <tradeName>06975491761003</tradeName>
    <deviceName>Monkeypox Virus (MPXV) Antigen Test (Colloidal Gold)</deviceName>
    <manufacturerName>Shenzhen Sciarray Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000038307</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103030501</emdnCode>
    <emdnDescription>OTHER ANTIGEN TYPING REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1 test/ kit</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:52:14.706Z</lastUpdated>
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    <udiDi>03770008181496</udiDi>
    <basicUdiDi>B-03770008181496</basicUdiDi>
    <tradeName>03770008181496</tradeName>
    <deviceName>Anti-Kell (clone MS-56)</deviceName>
    <manufacturerName>Institut de Biotechnologies Jacques Boy</manufacturerName>
    <manufacturerSrn>FR-MF-000004609</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste A</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103030501</emdnCode>
    <emdnDescription>OTHER ANTIGEN TYPING REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>152250263</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-05T19:21:17.556Z</lastUpdated>
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    <udiDi>D-01.244-02CZ</udiDi>
    <basicUdiDi>B-01.244-02CZ</basicUdiDi>
    <tradeName>Anti-Jsb for card method monocolonal, IgG</tradeName>
    <deviceName>Anti-Jsb for card method monocolonal, IgG - 01.244-02</deviceName>
    <manufacturerName>ANTITOXIN GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000008156</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103030501</emdnCode>
    <emdnDescription>OTHER ANTIGEN TYPING REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>01.244-02</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T13:08:22.632Z</lastUpdated>
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    <udiDi>D-01.243-03CU</udiDi>
    <basicUdiDi>B-01.243-03CU</basicUdiDi>
    <tradeName>Anti-P1 for card method monoclonal, human IgM clone: P3NIL100</tradeName>
    <deviceName>Anti-P1 for card method monoclonal, human IgM clone: P3NIL100</deviceName>
    <manufacturerName>ANTITOXIN GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000008156</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103030501</emdnCode>
    <emdnDescription>OTHER ANTIGEN TYPING REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>01.243-03</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T13:08:20.228Z</lastUpdated>
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    <udiDi>D-01.242-03CM</udiDi>
    <basicUdiDi>B-01.242-03CM</basicUdiDi>
    <tradeName>Anti-Leb for card method monoclonal, human clone: P3F234MD4</tradeName>
    <deviceName>Anti-Leb for card method monoclonal, human clone: P3F234MD4</deviceName>
    <manufacturerName>ANTITOXIN GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000008156</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103030501</emdnCode>
    <emdnDescription>OTHER ANTIGEN TYPING REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>01.242-03</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T13:08:18.635Z</lastUpdated>
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    <udiDi>10888234300625</udiDi>
    <basicUdiDi>88823405W0103030501D26KK</basicUdiDi>
    <tradeName>immuClone (1) Anti-K IgM</tradeName>
    <deviceName>immuClone (1) Anti-K IgM and Galileo</deviceName>
    <manufacturerName>IMMUCOR Medizinische Diagnostik GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000006494</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf D</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103030501</emdnCode>
    <emdnDescription>OTHER ANTIGEN TYPING REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0008016</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T18:09:39.446Z</lastUpdated>
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    <udiDi>10888234300618</udiDi>
    <basicUdiDi>88823405W0103030501D15KE</basicUdiDi>
    <tradeName>Anti-K (Kell) quick</tradeName>
    <deviceName>Anti-K (Kell) quick</deviceName>
    <manufacturerName>IMMUCOR Medizinische Diagnostik GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000006494</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf D</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103030501</emdnCode>
    <emdnDescription>OTHER ANTIGEN TYPING REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0008015</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T18:09:37.824Z</lastUpdated>
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    <udiDi>10888234300601</udiDi>
    <basicUdiDi>88823405W0103030501D31KC</basicUdiDi>
    <tradeName>immuClone (2) Anti-K IgM</tradeName>
    <deviceName>immuClone (2) Anti-K IgM and Automated</deviceName>
    <manufacturerName>IMMUCOR Medizinische Diagnostik GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000006494</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf D</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103030501</emdnCode>
    <emdnDescription>OTHER ANTIGEN TYPING REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0008014</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T18:09:35.489Z</lastUpdated>
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    <udiDi>10888234002390</udiDi>
    <basicUdiDi>88823401W0103030501C104SR</basicUdiDi>
    <tradeName>Anti-k (Monoclonal) (IgG) Gamma-clone Blood Grouping Reagent</tradeName>
    <deviceName>Anti-k (Monoclonal) (IgG) Gamma-clone</deviceName>
    <manufacturerName>Immucor, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000011568</manufacturerSrn>
    <authorisedRepresentativeName>IMMUCOR Medizinische Diagnostik GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000007083</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103030501</emdnCode>
    <emdnDescription>OTHER ANTIGEN TYPING REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0004817</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T18:09:12.201Z</lastUpdated>
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    <udiDi>10888234001881</udiDi>
    <basicUdiDi>88823401W0103030501C100SH</basicUdiDi>
    <tradeName>Anti-Lea (Murine Monoclonal) Gamma-clone Blood Grouping Reagent</tradeName>
    <deviceName>Anti-Lea (Murine Monoclonal) Gamma-clone</deviceName>
    <manufacturerName>Immucor, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000011568</manufacturerSrn>
    <authorisedRepresentativeName>IMMUCOR Medizinische Diagnostik GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000007083</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103030501</emdnCode>
    <emdnDescription>OTHER ANTIGEN TYPING REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0004861</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T18:09:07.441Z</lastUpdated>
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    <udiDi>10888234001898</udiDi>
    <basicUdiDi>88823401W0103030501C101SK</basicUdiDi>
    <tradeName>Anti-Leb (Murine Monoclonal) Gamma-clone Blood Grouping Reagent</tradeName>
    <deviceName>Anti-Leb (Murine Monoclonal) Gamma-clone</deviceName>
    <manufacturerName>Immucor, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000011568</manufacturerSrn>
    <authorisedRepresentativeName>IMMUCOR Medizinische Diagnostik GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000007083</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103030501</emdnCode>
    <emdnDescription>OTHER ANTIGEN TYPING REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0004864</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T18:09:05.817Z</lastUpdated>
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    <udiDi>10888234001072</udiDi>
    <basicUdiDi>88823401W01030399A0000045</basicUdiDi>
    <tradeName>Specimen Diluent</tradeName>
    <deviceName>Specimen Diluent</deviceName>
    <manufacturerName>Immucor, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000011568</manufacturerSrn>
    <authorisedRepresentativeName>IMMUCOR Medizinische Diagnostik GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000007083</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103030501</emdnCode>
    <emdnDescription>OTHER ANTIGEN TYPING REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0066053</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-03T18:08:44.142Z</lastUpdated>
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    <udiDi>10888234000785</udiDi>
    <basicUdiDi>88823401W0103030501C201SQ</basicUdiDi>
    <tradeName>Anti-Kpb - Blood Grouping Reagent</tradeName>
    <deviceName>Anti-Kpb Blood Grouping Reagent</deviceName>
    <manufacturerName>Immucor, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000011568</manufacturerSrn>
    <authorisedRepresentativeName>IMMUCOR Medizinische Diagnostik GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000007083</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103030501</emdnCode>
    <emdnDescription>OTHER ANTIGEN TYPING REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0007550</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T18:08:27.312Z</lastUpdated>
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    <udiDi>10888234000778</udiDi>
    <basicUdiDi>88823401W0103030501C200SN</basicUdiDi>
    <tradeName>Anti-Kpa Blood Grouping Reagent</tradeName>
    <deviceName>Anti-Kpa</deviceName>
    <manufacturerName>Immucor, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000011568</manufacturerSrn>
    <authorisedRepresentativeName>IMMUCOR Medizinische Diagnostik GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000007083</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103030501</emdnCode>
    <emdnDescription>OTHER ANTIGEN TYPING REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0007540</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T18:08:24.910Z</lastUpdated>
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    <udiDi>06974472730366</udiDi>
    <basicUdiDi>697447273036MU</basicUdiDi>
    <tradeName>Novel Coronavirus Antigen Test Kit(Latex beads)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Sanqi Biomedical(Shandong)Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000030641</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
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    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103030501</emdnCode>
    <emdnDescription>OTHER ANTIGEN TYPING REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5480</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T13:16:18.091Z</lastUpdated>
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    <udiDi>06974472730359</udiDi>
    <basicUdiDi>697447273035MS</basicUdiDi>
    <tradeName>Novel Coronavirus Antigen Test Kit(Latex beads)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Sanqi Biomedical(Shandong)Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000030641</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103030501</emdnCode>
    <emdnDescription>OTHER ANTIGEN TYPING REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5480</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-02T13:16:17.298Z</lastUpdated>
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    <udiDi>04042091000626</udiDi>
    <basicUdiDi>40420910005M3F</basicUdiDi>
    <tradeName>immuClone Anti-N IgM</tradeName>
    <deviceName>immuClone Anti-N IgM and Automated</deviceName>
    <manufacturerName>IMMUCOR Medizinische Diagnostik GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000006494</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <emdnCode>W0103030501</emdnCode>
    <emdnDescription>OTHER ANTIGEN TYPING REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0009605</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T14:54:02.401Z</lastUpdated>
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    <basicUdiDi>40420910004M3C</basicUdiDi>
    <tradeName>immuClone Anti-M</tradeName>
    <deviceName>immuClone Anti-M and Galileo</deviceName>
    <manufacturerName>IMMUCOR Medizinische Diagnostik GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000006494</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103030501</emdnCode>
    <emdnDescription>OTHER ANTIGEN TYPING REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0009506</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T14:54:01.603Z</lastUpdated>
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    <udiDi>04042091000602</udiDi>
    <basicUdiDi>40420910003M39</basicUdiDi>
    <tradeName>Anti-Wr(a)</tradeName>
    <deviceName>Anti-Wr(a)</deviceName>
    <manufacturerName>IMMUCOR Medizinische Diagnostik GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000006494</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103030501</emdnCode>
    <emdnDescription>OTHER ANTIGEN TYPING REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0099120</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T14:54:00.011Z</lastUpdated>
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    <udiDi>04042091000572</udiDi>
    <basicUdiDi>40420910008M3Q</basicUdiDi>
    <tradeName>immuClone Anti-s IgM</tradeName>
    <deviceName>immuClone Anti-s IgM</deviceName>
    <manufacturerName>IMMUCOR Medizinische Diagnostik GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000006494</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103030501</emdnCode>
    <emdnDescription>OTHER ANTIGEN TYPING REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0009959</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T14:53:56.011Z</lastUpdated>
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