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    <tradeName>D-697994388Ir0293LE4</tradeName>
    <deviceName>Typhoid Ab IgM/IgG Test Kit</deviceName>
    <manufacturerName>Kangsheng Information Technology (Hangzhou) Co. LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000053775</manufacturerSrn>
    <authorisedRepresentativeName>Crealkraft GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000049943</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090199</emdnCode>
    <emdnDescription>BACTERIOLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Ir029</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:23:45.635Z</lastUpdated>
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    <udiDi>D-697994388Ir02338BY</udiDi>
    <basicUdiDi>B-697994388Ir02338BY</basicUdiDi>
    <tradeName>D-697994388Ir02338BY</tradeName>
    <deviceName>Gardneralla Vaginalis Rapid Test</deviceName>
    <manufacturerName>Kangsheng Information Technology (Hangzhou) Co. LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000053775</manufacturerSrn>
    <authorisedRepresentativeName>Crealkraft GmbH</authorisedRepresentativeName>
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    <legislation>IVDD</legislation>
    <emdnCode>W0105090199</emdnCode>
    <emdnDescription>BACTERIOLOGY - RT &amp; POC - OTHER</emdnDescription>
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    <reference>Ir023</reference>
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    <lastUpdated>2026-07-17T01:23:32.058Z</lastUpdated>
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    <udiDi>D-697994388Ir02236BP</udiDi>
    <basicUdiDi>B-697994388Ir02236BP</basicUdiDi>
    <tradeName>D-697994388Ir02236BP</tradeName>
    <deviceName>Candidiasis Antigen Test Kit</deviceName>
    <manufacturerName>Kangsheng Information Technology (Hangzhou) Co. LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000053775</manufacturerSrn>
    <authorisedRepresentativeName>Crealkraft GmbH</authorisedRepresentativeName>
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    <legislation>IVDD</legislation>
    <emdnCode>W0105090199</emdnCode>
    <emdnDescription>BACTERIOLOGY - RT &amp; POC - OTHER</emdnDescription>
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    <lastUpdated>2026-07-17T01:23:26.577Z</lastUpdated>
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    <udiDi>D-697994388Ir0193HDM</udiDi>
    <basicUdiDi>B-697994388Ir0193HDM</basicUdiDi>
    <tradeName>D-697994388Ir0193HDM</tradeName>
    <deviceName>Neisseria gonorrhoeae Antigen Test Kit</deviceName>
    <manufacturerName>Kangsheng Information Technology (Hangzhou) Co. LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000053775</manufacturerSrn>
    <authorisedRepresentativeName>Crealkraft GmbH</authorisedRepresentativeName>
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    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090199</emdnCode>
    <emdnDescription>BACTERIOLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Ir019</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:23:22.975Z</lastUpdated>
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    <udiDi>D-697994388Ir0163BCS</udiDi>
    <basicUdiDi>B-697994388Ir0163BCS</basicUdiDi>
    <tradeName>D-697994388Ir0163BCS</tradeName>
    <deviceName>Treponema pallidum Antibody Test Kit</deviceName>
    <manufacturerName>Kangsheng Information Technology (Hangzhou) Co. LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000053775</manufacturerSrn>
    <authorisedRepresentativeName>Crealkraft GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000049943</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090199</emdnCode>
    <emdnDescription>BACTERIOLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Ir016</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:23:21.903Z</lastUpdated>
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    <udiDi>D-697424646TYP004USGX</udiDi>
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    <tradeName>Typhoid IgG/IgM Rapid Test (Serum/Plasma)</tradeName>
    <deviceName>Typhoid IgG/IgM Rapid Test (Serum/Plasma)</deviceName>
    <manufacturerName>SAFECARE BIOTECH (HANGZHOU) CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000019109</manufacturerSrn>
    <authorisedRepresentativeName>UnicareQ GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000051497</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090199</emdnCode>
    <emdnDescription>BACTERIOLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TYP-3022</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:16:05.052Z</lastUpdated>
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    <udiDi>D-697424646TYP003UQGN</udiDi>
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    <tradeName>Typhoid IgG/IgM Rapid Test (Whole Blood/Serum/Plasma)</tradeName>
    <deviceName>Typhoid IgG/IgM Rapid Test (Whole Blood/Serum/Plasma)</deviceName>
    <manufacturerName>SAFECARE BIOTECH (HANGZHOU) CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000019109</manufacturerSrn>
    <authorisedRepresentativeName>UnicareQ GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000051497</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090199</emdnCode>
    <emdnDescription>BACTERIOLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TYP-4022</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:16:03.567Z</lastUpdated>
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    <udiDi>D-697424646TYP002UNGB</udiDi>
    <basicUdiDi>B-697424646TYP002UNGB</basicUdiDi>
    <tradeName>S.Typhi(TYP) Antigen Rapid Test (Feces)</tradeName>
    <deviceName>S.Typhi(TYP) Antigen Rapid Test (Feces)</deviceName>
    <manufacturerName>SAFECARE BIOTECH (HANGZHOU) CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000019109</manufacturerSrn>
    <authorisedRepresentativeName>UnicareQ GmbH</authorisedRepresentativeName>
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    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090199</emdnCode>
    <emdnDescription>BACTERIOLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TYP Ag-5012</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:15:59.680Z</lastUpdated>
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    <udiDi>D-697424646TYP000UJFR</udiDi>
    <basicUdiDi>B-697424646TYP000UJFR</basicUdiDi>
    <tradeName>Typhoid IgG/IgM Rapid Test Kit (Whole Blood/serum/plasma)</tradeName>
    <deviceName>Typhoid IgG/IgM Rapid Test Kit (Whole Blood/serum/plasma)</deviceName>
    <manufacturerName>SAFECARE BIOTECH (HANGZHOU) CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000019109</manufacturerSrn>
    <authorisedRepresentativeName>Wellkang Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>XI-AR-000001836</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090199</emdnCode>
    <emdnDescription>BACTERIOLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TYP-4022</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:15:58.579Z</lastUpdated>
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    <udiDi>D-697424646TYP(F)000UJVY</udiDi>
    <basicUdiDi>B-697424646TYP(F)000UJVY</basicUdiDi>
    <tradeName>S.Typhi Antigen Rapid Test  (Feces)</tradeName>
    <deviceName>S.Typhi Antigen Rapid Test  (Feces)</deviceName>
    <manufacturerName>SAFECARE BIOTECH (HANGZHOU) CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000019109</manufacturerSrn>
    <authorisedRepresentativeName>Wellkang Ltd</authorisedRepresentativeName>
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    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090199</emdnCode>
    <emdnDescription>BACTERIOLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TYP Ag-5012</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:15:57.414Z</lastUpdated>
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    <udiDi>D-697424646TB002GWKG</udiDi>
    <basicUdiDi>B-697424646TB002GWKG</basicUdiDi>
    <tradeName>Tuberculosis Rapid Test (Serum/Plasma)</tradeName>
    <deviceName>Tuberculosis Rapid Test (Serum/Plasma)</deviceName>
    <manufacturerName>SAFECARE BIOTECH (HANGZHOU) CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000019109</manufacturerSrn>
    <authorisedRepresentativeName>UnicareQ GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000051497</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090199</emdnCode>
    <emdnDescription>BACTERIOLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TB-3011/TB-3012</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:15:37.270Z</lastUpdated>
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    <udiDi>D-697424646TB001GUK7</udiDi>
    <basicUdiDi>B-697424646TB001GUK7</basicUdiDi>
    <tradeName>Tuberculosis Rapid Test (Whole Blood/Serum/Plasma)</tradeName>
    <deviceName>Tuberculosis Rapid Test (Whole Blood/Serum/Plasma)</deviceName>
    <manufacturerName>SAFECARE BIOTECH (HANGZHOU) CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000019109</manufacturerSrn>
    <authorisedRepresentativeName>UnicareQ GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000051497</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090199</emdnCode>
    <emdnDescription>BACTERIOLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TB-4011/TB-4012</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:15:36.590Z</lastUpdated>
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    <udiDi>D-697424646TB000GSJW</udiDi>
    <basicUdiDi>B-697424646TB000GSJW</basicUdiDi>
    <tradeName>Tuberculosis Rapid Test Kit(Whole Blood/serum/plasma)</tradeName>
    <deviceName>Tuberculosis Rapid Test Kit(Whole Blood/serum/plasma)</deviceName>
    <manufacturerName>SAFECARE BIOTECH (HANGZHOU) CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000019109</manufacturerSrn>
    <authorisedRepresentativeName>Wellkang Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>XI-AR-000001836</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090199</emdnCode>
    <emdnDescription>BACTERIOLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TB-4011/TB-4012</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:15:35.803Z</lastUpdated>
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    <udiDi>69743840310498</udiDi>
    <basicUdiDi>B-69743840310498</basicUdiDi>
    <tradeName>Ehrlichia Antibody Rapid Test</tradeName>
    <deviceName>Ehrlichia Antibody Rapid Test</deviceName>
    <manufacturerName>Zhejiang Anji Saianfu Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000045029</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090199</emdnCode>
    <emdnDescription>BACTERIOLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>3023501</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:12:19.961Z</lastUpdated>
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    <udiDi>69743840310184</udiDi>
    <basicUdiDi>B-69743840310184</basicUdiDi>
    <tradeName>Anaplasmosis Antibody Rapid Test</tradeName>
    <deviceName>Anaplasmosis Antibody Rapid Test</deviceName>
    <manufacturerName>Zhejiang Anji Saianfu Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000045029</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
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    <emdnDescription>BACTERIOLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>3023401</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:12:14.564Z</lastUpdated>
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    <udiDi>69743840307832</udiDi>
    <basicUdiDi>B-69743840307832</basicUdiDi>
    <tradeName>Mycobacterium Tuberculosis Antibody Rapid Test</tradeName>
    <deviceName>Mycobacterium Tuberculosis Antibody Rapid Test</deviceName>
    <manufacturerName>Zhejiang Anji Saianfu Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000045029</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090199</emdnCode>
    <emdnDescription>BACTERIOLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>3021801</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:11:21.119Z</lastUpdated>
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    <udiDi>69743840303872</udiDi>
    <basicUdiDi>B-69743840303872</basicUdiDi>
    <tradeName>Typhoid Antigen Rapid Test</tradeName>
    <deviceName>Typhoid Antigen Rapid Test</deviceName>
    <manufacturerName>Zhejiang Anji Saianfu Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000045029</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
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    <legislation>IVDD</legislation>
    <emdnCode>W0105090199</emdnCode>
    <emdnDescription>BACTERIOLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>3021401</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:10:53.468Z</lastUpdated>
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    <basicUdiDi>B-697424646MID-U000Y2UB</basicUdiDi>
    <tradeName>Legionella &amp; S.pneumoniae Antigen Combo Rapid Test(Urine)</tradeName>
    <deviceName>Legionella &amp; S.pneumoniae Antigen Combo Rapid Test(Urine)</deviceName>
    <manufacturerName>SAFECARE BIOTECH (HANGZHOU) CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000019109</manufacturerSrn>
    <authorisedRepresentativeName>UnicareQ GmbH</authorisedRepresentativeName>
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    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090199</emdnCode>
    <emdnDescription>BACTERIOLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MID-1022</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:09:05.358Z</lastUpdated>
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    <udiDi>D-697424646GON001KFYS</udiDi>
    <basicUdiDi>B-697424646GON001KFYS</basicUdiDi>
    <tradeName>Gonorrhoea Rapid Test(Swab)</tradeName>
    <deviceName>Gonorrhoea Rapid Test(Swab)</deviceName>
    <manufacturerName>SAFECARE BIOTECH (HANGZHOU) CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000019109</manufacturerSrn>
    <authorisedRepresentativeName>UnicareQ GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000051497</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090199</emdnCode>
    <emdnDescription>BACTERIOLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GON-6012</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:06:25.117Z</lastUpdated>
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    <basicUdiDi>B-697424646GON000KDYH</basicUdiDi>
    <tradeName>Gonorrhoea Rapid Test Kit(Swab)</tradeName>
    <deviceName>Gonorrhoea Rapid Test Kit(Swab)</deviceName>
    <manufacturerName>SAFECARE BIOTECH (HANGZHOU) CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000019109</manufacturerSrn>
    <authorisedRepresentativeName>Wellkang Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>XI-AR-000001836</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090199</emdnCode>
    <emdnDescription>BACTERIOLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GON-6012</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:06:24.160Z</lastUpdated>
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