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    <tradeName>Natural rubber latex male condoms</tradeName>
    <deviceName>Natural rubber latex male condoms</deviceName>
    <manufacturerName>FITONE  LATEX  PRODUCTS  CO., LTD. GUANGDONG</manufacturerName>
    <manufacturerSrn>CN-MF-000012805</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U110101</emdnCode>
    <emdnDescription>CONDOMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>COM006</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-29T13:56:05.768Z</lastUpdated>
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    <udiDi>06959373819846</udiDi>
    <basicUdiDi>695937380004NQ</basicUdiDi>
    <tradeName>Natural rubber latex male condoms-Smooth</tradeName>
    <deviceName>Natural rubber latex male condoms</deviceName>
    <manufacturerName>FITONE  LATEX  PRODUCTS  CO., LTD. GUANGDONG</manufacturerName>
    <manufacturerSrn>CN-MF-000012805</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U110101</emdnCode>
    <emdnDescription>CONDOMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-29T13:56:04.568Z</lastUpdated>
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    <udiDi>06959373819839</udiDi>
    <basicUdiDi>695937380004NQ</basicUdiDi>
    <tradeName>Natural rubber latex male condoms- smooth</tradeName>
    <deviceName>Natural rubber latex male condoms</deviceName>
    <manufacturerName>FITONE  LATEX  PRODUCTS  CO., LTD. GUANGDONG</manufacturerName>
    <manufacturerSrn>CN-MF-000012805</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U110101</emdnCode>
    <emdnDescription>CONDOMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-29T13:56:03.369Z</lastUpdated>
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    <udiDi>06959373815305</udiDi>
    <basicUdiDi>695937380006NU</basicUdiDi>
    <tradeName>Fitone Natural Rubber Latex Probe Covers</tradeName>
    <deviceName>Sterile Natural Rubber Latex Probe Covers</deviceName>
    <manufacturerName>FITONE  LATEX  PRODUCTS  CO., LTD. GUANGDONG</manufacturerName>
    <manufacturerSrn>CN-MF-000012805</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>T030102</emdnCode>
    <emdnDescription>COVER SHEATHS, INSTRUMENTS AND EQUIPMENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PC100</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-29T13:55:57.365Z</lastUpdated>
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    <udiDi>06959373812793</udiDi>
    <basicUdiDi>695937380008NY</basicUdiDi>
    <tradeName>Fitone Natural Rubber Latex Probe Covers</tradeName>
    <deviceName>Natural Latex Rubber Probe Covers</deviceName>
    <manufacturerName>FITONE  LATEX  PRODUCTS  CO., LTD. GUANGDONG</manufacturerName>
    <manufacturerSrn>CN-MF-000012805</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>T030102</emdnCode>
    <emdnDescription>COVER SHEATHS, INSTRUMENTS AND EQUIPMENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PC002</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-29T13:55:56.162Z</lastUpdated>
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    <udiDi>06959373810409</udiDi>
    <basicUdiDi>695937380005NS</basicUdiDi>
    <tradeName>06959373810409</tradeName>
    <deviceName>Sterile Single-use Medical Latex Examination Gloves</deviceName>
    <manufacturerName>FITONE  LATEX  PRODUCTS  CO., LTD. GUANGDONG</manufacturerName>
    <manufacturerSrn>CN-MF-000012805</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>T010201</emdnCode>
    <emdnDescription>LATEX EXAMINATION / TREATMENT GLOVES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SLG100-XS</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-29T13:55:54.960Z</lastUpdated>
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    <udiDi>06959373809656</udiDi>
    <basicUdiDi>695937380003NN</basicUdiDi>
    <tradeName>Single-use Sterile Latex Surgical Gloves</tradeName>
    <deviceName>Single-use Sterile Latex Surgical Gloves</deviceName>
    <manufacturerName>FITONE  LATEX  PRODUCTS  CO., LTD. GUANGDONG</manufacturerName>
    <manufacturerSrn>CN-MF-000012805</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>T01010102</emdnCode>
    <emdnDescription>NON-POWDERED LATEX SURGICAL GLOVES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EFT10</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-06-29T13:55:53.770Z</lastUpdated>
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    <udiDi>06959373809557</udiDi>
    <basicUdiDi>695937380002NL</basicUdiDi>
    <tradeName>Fitone Single-use Medical Latex Examination Gloves</tradeName>
    <deviceName>Single-use Medical Latex Examination Gloves</deviceName>
    <manufacturerName>FITONE  LATEX  PRODUCTS  CO., LTD. GUANGDONG</manufacturerName>
    <manufacturerSrn>CN-MF-000012805</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>T010201</emdnCode>
    <emdnDescription>LATEX EXAMINATION / TREATMENT GLOVES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LG100-XS</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-29T13:55:47.761Z</lastUpdated>
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    <udiDi>06959373809502</udiDi>
    <basicUdiDi>695937380001NJ</basicUdiDi>
    <tradeName>Fitone Medical Nitrile Examination Gloves</tradeName>
    <deviceName>Medical Nitrile Examination Gloves</deviceName>
    <manufacturerName>FITONE  LATEX  PRODUCTS  CO., LTD. GUANGDONG</manufacturerName>
    <manufacturerSrn>CN-MF-000012805</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>T01020204</emdnCode>
    <emdnDescription>NITRILE EXAMINATION / TREATMENT GLOVES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NG001-XS</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-29T13:55:46.560Z</lastUpdated>
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