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    <deviceName>Dental Mirror</deviceName>
    <manufacturerName>SHANGHAI HUA EN INDUSTRIAL CO LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000008902</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q010504</emdnCode>
    <emdnDescription>DENTISTRY MIRRORS AND STYLETS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HNMM7503</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-02T11:37:17.924Z</lastUpdated>
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    <deviceName>Dental cotton roll</deviceName>
    <manufacturerName>SHANGHAI HUA EN INDUSTRIAL CO LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000008902</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q019004</emdnCode>
    <emdnDescription>DENTAL COTTON ROLLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HN1035</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-02T11:37:15.533Z</lastUpdated>
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    <deviceName>Sterilization pouch/reel</deviceName>
    <manufacturerName>SHANGHAI HUA EN INDUSTRIAL CO LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000008902</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>S010199</emdnCode>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>HN001</reference>
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    <lastUpdated>2026-07-02T11:37:13.920Z</lastUpdated>
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    <deviceName>Bite Tray</deviceName>
    <manufacturerName>SHANGHAI HUA EN INDUSTRIAL CO LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000008902</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>G030804</emdnCode>
    <emdnDescription>GASTROINTESTINAL ENDOSCOPY AND ECHOENDOSCOPY, BITE BLOCKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HNBT3001-5</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-02T11:37:13.142Z</lastUpdated>
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    <udiDi>06973454361703</udiDi>
    <basicUdiDi>697345436HNMA11342K</basicUdiDi>
    <tradeName>06973454361703</tradeName>
    <deviceName>Micro Applicator</deviceName>
    <manufacturerName>SHANGHAI HUA EN INDUSTRIAL CO LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000008902</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>V9099</emdnCode>
    <emdnDescription>VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HNMA1134</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-02T11:37:11.520Z</lastUpdated>
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    <basicUdiDi>697345436HNEB0045XC</basicUdiDi>
    <tradeName>06973454361604</tradeName>
    <deviceName>Elastic Bandage</deviceName>
    <manufacturerName>SHANGHAI HUA EN INDUSTRIAL CO LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000008902</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>M03030199</emdnCode>
    <emdnDescription>ELASTIC FIXING BANDAGES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HNEB0045</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-02T11:37:09.139Z</lastUpdated>
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    <deviceName>Face Shield</deviceName>
    <manufacturerName>SHANGHAI HUA EN INDUSTRIAL CO LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000008902</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>HNFS20151</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-02T11:37:07.562Z</lastUpdated>
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    <deviceName>Suction Tips</deviceName>
    <manufacturerName>SHANGHAI HUA EN INDUSTRIAL CO LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000008902</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q010599</emdnCode>
    <emdnDescription>DENTAL INSTRUMENTS, SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HNLB45</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-02T11:37:06.730Z</lastUpdated>
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    <udiDi>06973454361307</udiDi>
    <basicUdiDi>697345436HNPB150048</basicUdiDi>
    <tradeName>06973454361307</tradeName>
    <deviceName>Prophy Brush</deviceName>
    <manufacturerName>SHANGHAI HUA EN INDUSTRIAL CO LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000008902</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>V070101</emdnCode>
    <emdnDescription>ENDOSCOPES CLEANING BRUSHES - FOR GENERIC USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HNPB1500</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-02T11:37:05.117Z</lastUpdated>
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    <udiDi>06973454361208</udiDi>
    <basicUdiDi>697345436HNPPDC0025FG</basicUdiDi>
    <tradeName>06973454361208</tradeName>
    <deviceName>Doctor Cap</deviceName>
    <manufacturerName>SHANGHAI HUA EN INDUSTRIAL CO LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000008902</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>T0207</emdnCode>
    <emdnDescription>CAPS AND HEADWEAR (EXCLUDING PERSONAL PROTECTIVE EQUIPMENT - PPE)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HNPPDC0025</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-02T11:37:02.713Z</lastUpdated>
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    <udiDi>06973454361109</udiDi>
    <basicUdiDi>697345436HN1133DL</basicUdiDi>
    <tradeName>06973454361109</tradeName>
    <deviceName>Air water syringe tip</deviceName>
    <manufacturerName>SHANGHAI HUA EN INDUSTRIAL CO LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000008902</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q010599</emdnCode>
    <emdnDescription>DENTAL INSTRUMENTS, SINGLE-USE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HN1133</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-02T11:37:01.117Z</lastUpdated>
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    <basicUdiDi>697345436HNFC9002ZH</basicUdiDi>
    <tradeName>06973454361000</tradeName>
    <deviceName>Chair Cover</deviceName>
    <manufacturerName>SHANGHAI HUA EN INDUSTRIAL CO LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000008902</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>T0299</emdnCode>
    <emdnDescription>PROTECTION DRAPES AND GARMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HNFC9002</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-02T11:37:00.329Z</lastUpdated>
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    <basicUdiDi>697345436HNWS0045CL</basicUdiDi>
    <tradeName>06973454360904</tradeName>
    <deviceName>Wrapping Sheet</deviceName>
    <manufacturerName>SHANGHAI HUA EN INDUSTRIAL CO LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000008902</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>T030502</emdnCode>
    <emdnDescription>BED AND STRETCHER HYGIENIC COVERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HNWS0045</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-02T11:36:58.708Z</lastUpdated>
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    <tradeName>06973454360805</tradeName>
    <deviceName>Nonwoven Swab</deviceName>
    <manufacturerName>SHANGHAI HUA EN INDUSTRIAL CO LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000008902</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A1101</emdnCode>
    <emdnDescription>SAMPLE COLLECTION NEUTRAL SWABS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HNSW0204</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-02T11:36:56.326Z</lastUpdated>
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    <tradeName>06973454360706</tradeName>
    <deviceName>Nonwoven Shoe Cover</deviceName>
    <manufacturerName>SHANGHAI HUA EN INDUSTRIAL CO LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000008902</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>HNSC4016</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-02T11:36:54.712Z</lastUpdated>
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    <tradeName>06973454360607</tradeName>
    <deviceName>Mattress cover</deviceName>
    <manufacturerName>SHANGHAI HUA EN INDUSTRIAL CO LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000008902</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
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    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>V08068002</emdnCode>
    <emdnDescription>BED SUPPORTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HNMC210</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-02T11:36:53.911Z</lastUpdated>
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    <tradeName>06973454360508</tradeName>
    <deviceName>Sport Tape</deviceName>
    <manufacturerName>SHANGHAI HUA EN INDUSTRIAL CO LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000008902</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
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    <riskClass>Sınıf I</riskClass>
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    <emdnCode>M03030199</emdnCode>
    <emdnDescription>ELASTIC FIXING BANDAGES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HNST38138</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-02T11:36:52.318Z</lastUpdated>
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    <tradeName>06973454360409</tradeName>
    <deviceName>Nonwoven Lab Coat</deviceName>
    <manufacturerName>SHANGHAI HUA EN INDUSTRIAL CO LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000008902</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
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    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
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    <emdnDescription>PROTECTION DRAPES AND GARMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HNLB45</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-02T11:36:49.913Z</lastUpdated>
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    <tradeName>06973454360300</tradeName>
    <deviceName>Nonwoven Isolation gown</deviceName>
    <manufacturerName>SHANGHAI HUA EN INDUSTRIAL CO LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000008902</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
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    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>T0299</emdnCode>
    <emdnDescription>PROTECTION DRAPES AND GARMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HNSMS25</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-02T11:36:48.313Z</lastUpdated>
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    <tradeName>06973454360201</tradeName>
    <deviceName>Barrier Film/Sleeves</deviceName>
    <manufacturerName>SHANGHAI HUA EN INDUSTRIAL CO LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000008902</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>T030102</emdnCode>
    <emdnDescription>COVER SHEATHS, INSTRUMENTS AND EQUIPMENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HN8701</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-02T11:36:47.499Z</lastUpdated>
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