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    <basicUdiDi>697576047RS32S3</basicUdiDi>
    <tradeName>06975760470131</tradeName>
    <deviceName>RS32 All In One Digital PCR System</deviceName>
    <manufacturerName>Suzhou Precigenome Ltd, Co;</manufacturerName>
    <manufacturerSrn>CN-MF-000024105</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005110</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02050180</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RS3204 , RS3205, RS3206, RS3207</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-02T16:45:01.897Z</lastUpdated>
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    <udiDi>06975614169044</udiDi>
    <basicUdiDi>697561416NAT1N7</basicUdiDi>
    <tradeName>06975614169044</tradeName>
    <deviceName>Fully-Automated Nucleic Acid Amplification Testing System</deviceName>
    <manufacturerName>Genewise Bio Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000038313</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02050399</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INSTRUMENTS - RAPID AND POINT OF CARE TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NAT-3000</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-02T16:24:15.068Z</lastUpdated>
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    <udiDi>06975608185128</udiDi>
    <basicUdiDi>697560818model03FD</basicUdiDi>
    <tradeName>Gene Sequencer</tradeName>
    <deviceName>Gene Sequencer</deviceName>
    <manufacturerName>Sikun Life Science Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000047921</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02050108</emdnCode>
    <emdnDescription>GENETIC SYSTEM READERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5128</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-02T16:22:46.951Z</lastUpdated>
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    <udiDi>06975608185067</udiDi>
    <basicUdiDi>697560818model01F9</basicUdiDi>
    <tradeName>Sikun 2000</tradeName>
    <deviceName>Gene Sequencer</deviceName>
    <manufacturerName>Sikun Life Science Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000047921</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02050115</emdnCode>
    <emdnDescription>DNA SYNTHESIZERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5067</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-02T16:22:42.951Z</lastUpdated>
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    <udiDi>06975600660043</udiDi>
    <basicUdiDi>697560066Ideal66MQ</basicUdiDi>
    <tradeName>Automatic Nucleic Acid Detection Analyzer</tradeName>
    <deviceName>Automatic Nucleic Acid Detection Analyzer</deviceName>
    <manufacturerName>Guangdong RunPon Bioscience Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000025972</manufacturerSrn>
    <authorisedRepresentativeName>Share info GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005132</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02050116</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>N/A</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T16:22:40.947Z</lastUpdated>
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    <udiDi>06975600660036</udiDi>
    <basicUdiDi>697560066Ideal36MF</basicUdiDi>
    <tradeName>Automatic Nucleic Acid Detection Analyzer</tradeName>
    <deviceName>Automatic Nucleic Acid Detection Analyzer</deviceName>
    <manufacturerName>Guangdong RunPon Bioscience Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000025972</manufacturerSrn>
    <authorisedRepresentativeName>Share info GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005132</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02050116</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>N/A</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T16:22:39.915Z</lastUpdated>
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    <udiDi>06975600660029</udiDi>
    <basicUdiDi>697560066Ideal30M3</basicUdiDi>
    <tradeName>Automatic Nucleic Acid Detection Analyzer</tradeName>
    <deviceName>Automatic Nucleic Acid Detection Analyzer</deviceName>
    <manufacturerName>Guangdong RunPon Bioscience Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000025972</manufacturerSrn>
    <authorisedRepresentativeName>Share info GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005132</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02050116</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>WO2050116</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T16:22:35.756Z</lastUpdated>
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    <udiDi>06975600660005</udiDi>
    <basicUdiDi>697560066I11NS</basicUdiDi>
    <tradeName>Real-time PCR Instrument</tradeName>
    <deviceName>Real-time PCR Instrument</deviceName>
    <manufacturerName>Guangdong RunPon Bioscience Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000025972</manufacturerSrn>
    <authorisedRepresentativeName>Share info GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005132</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02050116</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P810</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T16:22:34.957Z</lastUpdated>
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    <udiDi>06975578360273</udiDi>
    <basicUdiDi>697557836030020002Z6</basicUdiDi>
    <tradeName>Magnetic Rod Sleeve</tradeName>
    <deviceName>Magnetic Rod Sleeve</deviceName>
    <manufacturerName>Pilot Gene Technology (Hangzhou) Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000023002</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02050185</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3060340</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-02T16:19:13.171Z</lastUpdated>
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  <row>
    <udiDi>06975578360020</udiDi>
    <basicUdiDi>697557836020020001YH</basicUdiDi>
    <tradeName>Automated Nucleic Acid Detection Reaction Construction System</tradeName>
    <deviceName>Automated Nucleic Acid Detection Reaction Construction System</deviceName>
    <manufacturerName>Pilot Gene Technology (Hangzhou) Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000023002</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02050106</emdnCode>
    <emdnDescription>DNA GENOMIC PREPARATION DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1000042</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-02T16:19:06.755Z</lastUpdated>
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    <udiDi>06975578360037</udiDi>
    <basicUdiDi>697557836020010001Y6</basicUdiDi>
    <tradeName>Automated Digital PCR System</tradeName>
    <deviceName>Automated Digital PCR System</deviceName>
    <manufacturerName>Pilot Gene Technology (Hangzhou) Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000023002</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02050116</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1200889</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-02T16:19:05.963Z</lastUpdated>
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    <udiDi>06975578360006</udiDi>
    <basicUdiDi>697557836030010002YT</basicUdiDi>
    <tradeName>Microfluidic Chip</tradeName>
    <deviceName>Microfluidic Chip</deviceName>
    <manufacturerName>Pilot Gene Technology (Hangzhou) Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000023002</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02050185</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INSTRUMENTS EXCEPT MICRO-ARRAYS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3100053</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-02T16:19:04.352Z</lastUpdated>
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    <udiDi>06975514360800</udiDi>
    <basicUdiDi>697551436ThermalcyclerDH</basicUdiDi>
    <tradeName>06975514360800</tradeName>
    <deviceName>Thermal cycler</deviceName>
    <manufacturerName>Hangzhou Bigfish Bio-tech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000027212</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02050116</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FC-96G</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-02T16:13:20.891Z</lastUpdated>
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    <udiDi>06927210914634</udiDi>
    <basicUdiDi>697550352DH100SERGX</basicUdiDi>
    <tradeName>In-situ Denaturation and Hybridization Processor</tradeName>
    <deviceName>In-situ Denaturation and Hybridization Processor</deviceName>
    <manufacturerName>Shenzhen Dartmon Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000019183</manufacturerSrn>
    <authorisedRepresentativeName>Umedwings Netherlands B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000444</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02050101</emdnCode>
    <emdnDescription>NUCLEIC ACID HYBRIDIZATION UNITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DH110</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-07-02T16:12:37.362Z</lastUpdated>
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    <udiDi>06975491760174</udiDi>
    <basicUdiDi>697549176ADEAMIPM</basicUdiDi>
    <tradeName>06975491760174</tradeName>
    <deviceName>Automatic DNA Extraction and Methylation instrument</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 Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02050399</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INSTRUMENTS - RAPID AND POINT OF CARE TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SEP-8</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-02T16:10:33.212Z</lastUpdated>
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    <udiDi>06975491760150</udiDi>
    <basicUdiDi>697549176ANAEAPIYC</basicUdiDi>
    <tradeName>06975491760150</tradeName>
    <deviceName>Automatic Nucleic Acid Extraction and Purification Instrument</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 Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02050299</emdnCode>
    <emdnDescription>MICRO-ARRAY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SET-48</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-02T16:10:32.405Z</lastUpdated>
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    <udiDi>06975488440065</udiDi>
    <basicUdiDi>697548844PCR22T5</basicUdiDi>
    <tradeName>Thermal Cycler&amp;Real-time PCR</tradeName>
    <deviceName>Thermal Cycler&amp;Real-time PCR</deviceName>
    <manufacturerName>Infitek Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000040107</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02050116</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PCR-96A</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-02T16:07:40.935Z</lastUpdated>
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    <udiDi>06975461700377</udiDi>
    <basicUdiDi>697546170QuantReadyKZ</basicUdiDi>
    <tradeName>06975461700377</tradeName>
    <deviceName>Real-Time Fluorescence Quantitative PCR system</deviceName>
    <manufacturerName>Hangzhou Lifereal Biotechnology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000019191</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02050301</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING APPARATUSES - RAPID AND POINT OF CARE TESTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>QuantReady K9600</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-02T16:05:24.751Z</lastUpdated>
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    <udiDi>06975457020045</udiDi>
    <basicUdiDi>697545702LifeReadyNG</basicUdiDi>
    <tradeName>06975457020045</tradeName>
    <deviceName>Automatic Integrated Gene Detection System</deviceName>
    <manufacturerName>Hangzhou Lifereal Biotechnology Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000030319</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02050116</emdnCode>
    <emdnDescription>NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LifeReady 1000</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-02T16:04:15.046Z</lastUpdated>
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    <udiDi>16975412638008</udiDi>
    <basicUdiDi>697541263UMSUR</basicUdiDi>
    <tradeName>Micro-Spectrophotometer</tradeName>
    <deviceName>Micro-Spectrophotometer</deviceName>
    <manufacturerName>Hangzhou Bio-gener Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000027988</manufacturerSrn>
    <authorisedRepresentativeName>MedPath GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000087</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02050101</emdnCode>
    <emdnDescription>NUCLEIC ACID HYBRIDIZATION UNITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BGNANO-601</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T16:00:41.272Z</lastUpdated>
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