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    <udiDi>05944759080096</udiDi>
    <basicUdiDi>5944759080VTSTA25STSMB6Y7</basicUdiDi>
    <tradeName>Rapid Test Cassette Strep A (Throat Swab) positive and negative controls included Test rapid Strep A (exudat), caseta, control pozitiv si control negativ incluse</tradeName>
    <deviceName>Rapid Test Cassette Strep A (Throat Swab) positive and negative controls included Test rapid Strep A (exudat), caseta, control pozitiv si control negativ incluse</deviceName>
    <manufacturerName>VitroBioChem SRL</manufacturerName>
    <manufacturerSrn>RO-MF-000010877</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105090103</emdnCode>
    <emdnDescription>STREP. A - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VT-STA-25</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-31T13:25:42.873Z</lastUpdated>
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    <udiDi>04065384000172</udiDi>
    <basicUdiDi>4065384STA1OPS4N1GXEW</basicUdiDi>
    <tradeName>NADAL® Strep A Test</tradeName>
    <deviceName>Strep A Test</deviceName>
    <manufacturerName>nal von minden GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000013321</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105090103</emdnCode>
    <emdnDescription>STREP. A - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>20122N20</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T20:21:47.747Z</lastUpdated>
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    <udiDi>D-IST-502(CT)Q4</udiDi>
    <basicUdiDi>B-IST-502(CT)Q4</basicUdiDi>
    <tradeName>D-IST-502(CT)Q4</tradeName>
    <deviceName>Strep A Rapid Test Cassette</deviceName>
    <manufacturerName>CITEST DIAGNOSTICS INC</manufacturerName>
    <manufacturerSrn>CA-MF-000022516</manufacturerSrn>
    <authorisedRepresentativeName>VidaQuick Biotech S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000048138</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090103</emdnCode>
    <emdnDescription>STREP. A - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-30T03:48:51.731Z</lastUpdated>
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    <udiDi>D-ISTB-R502GY</udiDi>
    <basicUdiDi>B-ISTB-R502GY</basicUdiDi>
    <tradeName>Strep A Rapid Test Cassette</tradeName>
    <deviceName>Strep A Rapid Test Cassette</deviceName>
    <manufacturerName>Hangzhou Alltest Biotech.Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010710</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090103</emdnCode>
    <emdnDescription>STREP. A - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ISTB-R502</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-24T22:44:36.030Z</lastUpdated>
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    <udiDi>D-ISTB-502N5</udiDi>
    <basicUdiDi>B-ISTB-502N5</basicUdiDi>
    <tradeName>Strep A Rapid Test Cassette</tradeName>
    <deviceName>Strep A Rapid Test Cassette</deviceName>
    <manufacturerName>Hangzhou Alltest Biotech.Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010710</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090103</emdnCode>
    <emdnDescription>STREP. A - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ISTB-502</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-24T22:44:35.290Z</lastUpdated>
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    <udiDi>D-ISTB-501N3</udiDi>
    <basicUdiDi>B-ISTB-501N3</basicUdiDi>
    <tradeName>Strep A Rapid Test Dipstick</tradeName>
    <deviceName>Strep A Rapid Test Dipstick</deviceName>
    <manufacturerName>Hangzhou Alltest Biotech.Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010710</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090103</emdnCode>
    <emdnDescription>STREP. A - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ISTB-501</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-24T22:44:34.430Z</lastUpdated>
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    <udiDi>D-IST-R502P5</udiDi>
    <basicUdiDi>B-IST-R502P5</basicUdiDi>
    <tradeName>Strep A Rapid Test Cassette</tradeName>
    <deviceName>Strep A Rapid Test Cassette</deviceName>
    <manufacturerName>Hangzhou Alltest Biotech.Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010710</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090103</emdnCode>
    <emdnDescription>STREP. A - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IST-R502</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-24T22:44:30.429Z</lastUpdated>
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    <udiDi>D-FI-STA-502X9</udiDi>
    <basicUdiDi>B-FI-STA-502X9</basicUdiDi>
    <tradeName>Strep A Test Cassette</tradeName>
    <deviceName>Strep A Test Cassette</deviceName>
    <manufacturerName>Hangzhou Alltest Biotech.Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010710</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090103</emdnCode>
    <emdnDescription>STREP. A - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FI-STA-502</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-24T22:42:35.973Z</lastUpdated>
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  <row>
    <udiDi>06952804804558</udiDi>
    <basicUdiDi>69528048A463101ZT</basicUdiDi>
    <tradeName>Strep A Rapid Test Device</tradeName>
    <deviceName>Strep A Rapid Test</deviceName>
    <manufacturerName>Assure Tech. (Hangzhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000002170</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105090103</emdnCode>
    <emdnDescription>STREP. A - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A4631011</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-22T20:09:01.476Z</lastUpdated>
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    <udiDi>06952804837174</udiDi>
    <basicUdiDi>69528048A463101ZT</basicUdiDi>
    <tradeName>Strep A Rapid Test Device</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Assure Tech. (Hangzhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000002170</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105090103</emdnCode>
    <emdnDescription>STREP. A - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A4631021</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-22T19:55:12.480Z</lastUpdated>
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    <udiDi>D-697994388Ir0443GDF</udiDi>
    <basicUdiDi>B-697994388Ir0443GDF</basicUdiDi>
    <tradeName>D-697994388Ir0443GDF</tradeName>
    <deviceName>Strep A Ag 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>W0105090103</emdnCode>
    <emdnDescription>STREP. A - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Ir044</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:24:32.676Z</lastUpdated>
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    <udiDi>D-697603130101A0202EYNC8E</udiDi>
    <basicUdiDi>B-697603130101A0202EYNC8E</basicUdiDi>
    <tradeName>D-697603130101A0202EYNC8E</tradeName>
    <deviceName>Group A Streptococcus Detection Kit (Fluorescence PCR)</deviceName>
    <manufacturerName>Hangzhou Danwei Biotechnology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000041344</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090103</emdnCode>
    <emdnDescription>STREP. A - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>101A0202EY</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:17:17.480Z</lastUpdated>
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    <udiDi>D-697424646STA001P74Y</udiDi>
    <basicUdiDi>B-697424646STA001P74Y</basicUdiDi>
    <tradeName>Strep A Rapid Test (Swab)</tradeName>
    <deviceName>Strep A 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>W0105090103</emdnCode>
    <emdnDescription>STREP. A - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>STA-6011/STA-6012</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:15:03.875Z</lastUpdated>
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    <udiDi>D-697424646STA000P54P</udiDi>
    <basicUdiDi>B-697424646STA000P54P</basicUdiDi>
    <tradeName>Strep A Rapid Test Kit (swab)</tradeName>
    <deviceName>Strep A 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>W0105090103</emdnCode>
    <emdnDescription>STREP. A - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>STA-6011/STA-6012</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:15:03.779Z</lastUpdated>
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    <udiDi>69743840307900</udiDi>
    <basicUdiDi>B-69743840307900</basicUdiDi>
    <tradeName>Strep A Rapid Test</tradeName>
    <deviceName>Strep A 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>W0105090103</emdnCode>
    <emdnDescription>STREP. A - RT &amp; POC</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>3021104</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:11:21.362Z</lastUpdated>
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    <udiDi>D-69717712009108W</udiDi>
    <basicUdiDi>B-69717712009108W</basicUdiDi>
    <tradeName>LYSUN</tradeName>
    <deviceName>Strep A Rapid Test</deviceName>
    <manufacturerName>Hangzhou Lysun Biotechnology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000010254</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090103</emdnCode>
    <emdnDescription>STREP. A - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>STP-S21（25PCS）</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:57:11.157Z</lastUpdated>
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    <udiDi>06976232252019</udiDi>
    <basicUdiDi>B-06976232252019</basicUdiDi>
    <tradeName>Acmex</tradeName>
    <deviceName>Group A Streptococcus (Strep A) Rapid Test</deviceName>
    <manufacturerName>Acmex Bio-Technology (Chongqing) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000037745</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090103</emdnCode>
    <emdnDescription>STREP. A - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CA03-19-422P25</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-16T16:32:09.983Z</lastUpdated>
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    <udiDi>06973861684297</udiDi>
    <basicUdiDi>B-06973861684297</basicUdiDi>
    <tradeName>06973861684297</tradeName>
    <deviceName>Group A Streptococcus Test Kit</deviceName>
    <manufacturerName>Anbio (Xiamen) Biotechnology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000023936</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090103</emdnCode>
    <emdnDescription>STREP. A - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A10013001D</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-16T16:12:02.703Z</lastUpdated>
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    <udiDi>06936983117289</udiDi>
    <basicUdiDi>6970277510014PYS</basicUdiDi>
    <tradeName>SCREEN® Strep A Test</tradeName>
    <deviceName>Strep A Rapid Test</deviceName>
    <manufacturerName>Hangzhou Alltest Biotech.Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010710</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105090103</emdnCode>
    <emdnDescription>STREP. A - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>987814454</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-16T07:56:41.770Z</lastUpdated>
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    <udiDi>D-nvm-222907N-20YR</udiDi>
    <basicUdiDi>B-nvm-222907N-20YR</basicUdiDi>
    <tradeName>NADAL® Strep A Plus Test</tradeName>
    <deviceName>Strep A Plus Test</deviceName>
    <manufacturerName>nal von minden GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000013321</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090103</emdnCode>
    <emdnDescription>STREP. A - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>222907N-20</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T11:27:50.878Z</lastUpdated>
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