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    <tradeName>K-ras Gene Mutations Detection Kit (Multiplex Fluorescence Polymerase Chain Reaction)</tradeName>
    <deviceName>K-ras Gene Mutations Detection Kit (Multiplex Fluorescence Polymerase Chain Reaction)</deviceName>
    <manufacturerName>XIAMEN SPACEGEN CO.,LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000018018</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W010699</emdnCode>
    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Lotus NL B.V.  Address：Koningin Julianaplein 10,1e Verd,2595AA,The Hague, Netherlands. Email：peter@lotusnl.com</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T11:57:10.509Z</lastUpdated>
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    <basicUdiDi>B-06972665700349</basicUdiDi>
    <tradeName>Colorectal Cancer Related Gene Mutation Detection Kit（High Throughput Sequencing）</tradeName>
    <deviceName>Colorectal Cancer Related Gene Mutation Detection Kit（High Throughput Sequencing）</deviceName>
    <manufacturerName>XIAMEN SPACEGEN CO.,LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000018018</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
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    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Lotus NL B.V.  Koningin Julianaplein 10, 1e Verd, 2595AA, The Hague, Netherlands.  E-mail:peter@lotusnl.com</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T11:57:04.536Z</lastUpdated>
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    <basicUdiDi>B-06972665700332</basicUdiDi>
    <tradeName>Colorectal Cancer Related Gene Mutation Detection Kit（High Throughput Sequencing）</tradeName>
    <deviceName>Colorectal Cancer Related Gene Mutation Detection Kit（High Throughput Sequencing）</deviceName>
    <manufacturerName>XIAMEN SPACEGEN CO.,LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000018018</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
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    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Lotus NL B.V.  Koningin Julianaplein 10, 1e Verd, 2595AA, The Hague, Netherlands.  E-mail:peter@lotusnl.com</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T11:57:03.734Z</lastUpdated>
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    <basicUdiDi>B-06972665700325</basicUdiDi>
    <tradeName>Thyroid Cancer Gene Mutation Detection Kit (High Throughput Sequencing)</tradeName>
    <deviceName>Thyroid Cancer Gene Mutation Detection Kit (High Throughput Sequencing)</deviceName>
    <manufacturerName>XIAMEN SPACEGEN CO.,LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000018018</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W010699</emdnCode>
    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Lotus NL B.V.  Koningin Julianaplein 10, 1e Verd, 2595AA, The Hague, Netherlands.  E-mail:peter@lotusnl.com</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T11:57:03.071Z</lastUpdated>
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    <udiDi>06972665700318</udiDi>
    <basicUdiDi>B-06972665700318</basicUdiDi>
    <tradeName>Thyroid Cancer Gene Mutation Detection Kit (High Throughput Sequencing)</tradeName>
    <deviceName>Thyroid Cancer Gene Mutation Detection Kit (High Throughput Sequencing)</deviceName>
    <manufacturerName>XIAMEN SPACEGEN CO.,LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000018018</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W010699</emdnCode>
    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Lotus NL B.V.  Koningin Julianaplein 10, 1e Verd, 2595AA, The Hague, Netherlands.  E-mail:peter@lotusnl.com</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T11:56:58.139Z</lastUpdated>
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    <udiDi>06972665700301</udiDi>
    <basicUdiDi>B-06972665700301</basicUdiDi>
    <tradeName>Human Lynch Syndrome Gene Detection Kit (High Throughput Sequencing)</tradeName>
    <deviceName>Human Lynch Syndrome Gene Detection Kit (High Throughput Sequencing)</deviceName>
    <manufacturerName>XIAMEN SPACEGEN CO.,LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000018018</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W010699</emdnCode>
    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Lotus NL B.V. Koningin Julianaplein 10, 1e Verd, 2595AA, The Hague, Netherlands. E-mail:peter@lotusnl.com</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T11:56:57.330Z</lastUpdated>
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    <basicUdiDi>B-06972665700295</basicUdiDi>
    <tradeName>Human Lynch Syndrome Gene Detection Kit (High Throughput Sequencing)</tradeName>
    <deviceName>Human Lynch Syndrome Gene Detection Kit (High Throughput Sequencing)</deviceName>
    <manufacturerName>XIAMEN SPACEGEN CO.,LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000018018</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W010699</emdnCode>
    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Lotus NL B.V. Koningin Julianaplein 10, 1e Verd, 2595AA, The Hague, Netherlands. E-mail:peter@lotusnl.com</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T11:56:56.963Z</lastUpdated>
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    <basicUdiDi>B-06972665700288</basicUdiDi>
    <tradeName>Human Pan-Cancer Drive Gene Mutations Detection Kit (High-Throughput Sequencing)</tradeName>
    <deviceName>Human Pan-Cancer Drive Gene Mutations Detection Kit (High-Throughput Sequencing)</deviceName>
    <manufacturerName>XIAMEN SPACEGEN CO.,LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000018018</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W010699</emdnCode>
    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Lotus NL B.V. Koningin Julianaplein 10, 1e Verd, 2595AA, The Hague, Netherlands. E-mail:peter@lotusnl.com</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T11:56:56.135Z</lastUpdated>
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    <udiDi>06972665700271</udiDi>
    <basicUdiDi>B-06972665700271</basicUdiDi>
    <tradeName>Human Pan-Cancer Drive Gene Mutations Detection Kit (High-Throughput Sequencing)</tradeName>
    <deviceName>Human Pan-Cancer Drive Gene Mutations Detection Kit (High-Throughput Sequencing)</deviceName>
    <manufacturerName>XIAMEN SPACEGEN CO.,LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000018018</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W010699</emdnCode>
    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Lotus NL B.V. Koningin Julianaplein 10, 1e Verd, 2595AA, The Hague, Netherlands. E-mail:peter@lotusnl.com</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T11:56:51.723Z</lastUpdated>
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    <udiDi>06972665700264</udiDi>
    <basicUdiDi>B-06972665700264</basicUdiDi>
    <tradeName>Human Endometrial Cancer Molecular Classification Detection Kit (High Throughput Sequencing)</tradeName>
    <deviceName>Human Endometrial Cancer Molecular Classification Detection Kit (High Throughput Sequencing)</deviceName>
    <manufacturerName>XIAMEN SPACEGEN CO.,LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000018018</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W010699</emdnCode>
    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Lotus NL B.V. Koningin Julianaplein 10, 1e Verd, 2595AA, The Hague, Netherlands. E-mail:peter@lotusnl.com</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T11:56:50.932Z</lastUpdated>
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    <udiDi>06972665700257</udiDi>
    <basicUdiDi>B-06972665700257</basicUdiDi>
    <tradeName>Human Endometrial Cancer Molecular Classification Detection Kit (High Throughput Sequencing)</tradeName>
    <deviceName>Human Endometrial Cancer Molecular Classification Detection Kit (High Throughput Sequencing)</deviceName>
    <manufacturerName>XIAMEN SPACEGEN CO.,LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000018018</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W010699</emdnCode>
    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Lotus NL B.V. Koningin Julianaplein 10, 1e Verd, 2595AA, The Hague, Netherlands. E-mail:peter@lotusnl.com</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T11:56:50.125Z</lastUpdated>
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    <basicUdiDi>B-06972665700240</basicUdiDi>
    <tradeName>Oncology Multi-Gene Mutations Detection Kit (High Throughput Sequencing)</tradeName>
    <deviceName>Oncology Multi-Gene Mutations Detection Kit (High Throughput Sequencing)</deviceName>
    <manufacturerName>XIAMEN SPACEGEN CO.,LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000018018</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W010699</emdnCode>
    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Name:Lotus NL B.V.  Address: Koningin Julianaplein 10,1e Verd,2595AA, The Hague,Netherlands. E-mail:peter@lotusnl.com</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T11:56:49.323Z</lastUpdated>
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    <basicUdiDi>B-06972665700233</basicUdiDi>
    <tradeName>Oncology Multi-Gene Mutations Detection Kit (High Throughput Sequencing)</tradeName>
    <deviceName>Oncology Multi-Gene Mutations Detection Kit (High Throughput Sequencing)</deviceName>
    <manufacturerName>XIAMEN SPACEGEN CO.,LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000018018</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W010699</emdnCode>
    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Name:Lotus NL B.V.     Address: Koningin Julianaplein 10,1e Verd,2595AA,The Hague, Netherlands. Email：peter@lotusnl.com</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T11:56:45.328Z</lastUpdated>
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    <basicUdiDi>B-06972665700110</basicUdiDi>
    <tradeName>BRCA1/2 Gene Mutations Detection Kit (High Throughput Sequencing)</tradeName>
    <deviceName>BRCA1/2 Gene Mutations Detection Kit (High Throughput Sequencing)</deviceName>
    <manufacturerName>XIAMEN SPACEGEN CO.,LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000018018</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W010699</emdnCode>
    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Lotus NL B.V.  Address：Koningin Julianaplein 10,1e Verd,2595AA,The Hague, Netherlands. Email：peter@lotusnl.com</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T11:56:42.957Z</lastUpdated>
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    <basicUdiDi>B-06972665700103</basicUdiDi>
    <tradeName>BRCA1/2 Gene Mutations Detection Kit (High Throughput Sequencing)</tradeName>
    <deviceName>BRCA1/2 Gene Mutations Detection Kit (High Throughput Sequencing)</deviceName>
    <manufacturerName>XIAMEN SPACEGEN CO.,LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000018018</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W010699</emdnCode>
    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Lotus NL B.V.  Address：Koningin Julianaplein 10,1e Verd,2595AA,The Hague, Netherlands. Email：peter@lotusnl.com</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T11:56:39.155Z</lastUpdated>
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    <tradeName>06972221450589</tradeName>
    <deviceName>Human Papillomavirus (HPV) Genotyping Detection Kit (Microarray)</deviceName>
    <manufacturerName>CapitalBio Technology (Chengdu) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000027694</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W010699</emdnCode>
    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>96 tests/kit</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T11:44:25.088Z</lastUpdated>
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    <basicUdiDi>B-06972221450572</basicUdiDi>
    <tradeName>06972221450572</tradeName>
    <deviceName>Human Papillomavirus (HPV) Genotyping Detection Kit (Microarray)</deviceName>
    <manufacturerName>CapitalBio Technology (Chengdu) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000027694</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W010699</emdnCode>
    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>24 tests/kit</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T11:44:22.293Z</lastUpdated>
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    <udiDi>06971042229275</udiDi>
    <basicUdiDi>B-06971042229275</basicUdiDi>
    <tradeName>GAPDH(Human) Real Time RT-PCR Kit</tradeName>
    <deviceName>GAPDH(Human) Real Time RT-PCR Kit</deviceName>
    <manufacturerName>SHANGHAI ZJ BIO-TECH CO., LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000017861</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W010699</emdnCode>
    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>QR-0132-02</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-06T09:04:05.986Z</lastUpdated>
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    <basicUdiDi>B-06971042229008</basicUdiDi>
    <tradeName>MTHFR C677T Mutation Real Time PCR Kit</tradeName>
    <deviceName>MTHFR C677T Mutation Real Time PCR Kit</deviceName>
    <manufacturerName>SHANGHAI ZJ BIO-TECH CO., LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000017861</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W010699</emdnCode>
    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GD-0135-02</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-06T09:03:10.462Z</lastUpdated>
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    <basicUdiDi>B-06970341686420RT</basicUdiDi>
    <tradeName>D-06970341686420RT</tradeName>
    <deviceName>Multiplex Real time PCR Kit for Monkeypox Virus and Central/West African Clade Typing</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>W010699</emdnCode>
    <emdnDescription>GENETIC TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>529010/ 529011</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-06T08:35:47.944Z</lastUpdated>
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