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    <basicUdiDi>86993436PTA18OTWHK</basicUdiDi>
    <tradeName>Simpass</tradeName>
    <deviceName>Simpass Endo18 OTW PTA Balloon Dilatation Catheter</deviceName>
    <manufacturerName>Simeks Tibbi Urunler San. ve Tic LTD STI</manufacturerName>
    <manufacturerSrn>TR-MF-000015871</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C010402020101</emdnCode>
    <emdnDescription>PTA BALLOON DILATATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SND20010-80</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-03T16:13:10.605Z</lastUpdated>
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    <udiDi>08699343612609</udiDi>
    <basicUdiDi>86993436PTA14RX8H</basicUdiDi>
    <tradeName>Simpass</tradeName>
    <deviceName>Simpass Endo14 RX PTA Balloon Dilatation Catheter</deviceName>
    <manufacturerName>Simeks Tibbi Urunler San. ve Tic LTD STI</manufacturerName>
    <manufacturerSrn>TR-MF-000015871</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C010402020101</emdnCode>
    <emdnDescription>PTA BALLOON DILATATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SPE20015-90</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-03T16:13:09.824Z</lastUpdated>
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    <udiDi>08699343601535</udiDi>
    <basicUdiDi>86993436PTA35OTWHL</basicUdiDi>
    <tradeName>Simpass</tradeName>
    <deviceName>Simpass Endo35 OTW PTA Balloon Dilatation Catheter</deviceName>
    <manufacturerName>Simeks Tibbi Urunler San. ve Tic LTD STI</manufacturerName>
    <manufacturerSrn>TR-MF-000015871</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C010402020101</emdnCode>
    <emdnDescription>PTA BALLOON DILATATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SE50020-80</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-03T16:13:09.016Z</lastUpdated>
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    <udiDi>08699343627030</udiDi>
    <basicUdiDi>86993436PTCASC89</basicUdiDi>
    <tradeName>Simpass</tradeName>
    <deviceName>Simpass Plus RX PTCA Balloon Dilatation Catheter</deviceName>
    <manufacturerName>Simeks Tibbi Urunler San. ve Tic LTD STI</manufacturerName>
    <manufacturerSrn>TR-MF-000015871</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C010401020101</emdnCode>
    <emdnDescription>PTCA BALLOON DILATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PS45042</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-06-30T23:52:36.571Z</lastUpdated>
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    <udiDi>08699343627023</udiDi>
    <basicUdiDi>86993436PTCASC89</basicUdiDi>
    <tradeName>Simpass</tradeName>
    <deviceName>Simpass Plus RX PTCA Balloon Dilatation Catheter</deviceName>
    <manufacturerName>Simeks Tibbi Urunler San. ve Tic LTD STI</manufacturerName>
    <manufacturerSrn>TR-MF-000015871</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C010401020101</emdnCode>
    <emdnDescription>PTCA BALLOON DILATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PS45032</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-06-30T23:52:35.369Z</lastUpdated>
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    <udiDi>08699343627016</udiDi>
    <basicUdiDi>86993436PTCASC89</basicUdiDi>
    <tradeName>Simpass</tradeName>
    <deviceName>Simpass Plus RX PTCA Balloon Dilatation Catheter</deviceName>
    <manufacturerName>Simeks Tibbi Urunler San. ve Tic LTD STI</manufacturerName>
    <manufacturerSrn>TR-MF-000015871</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C010401020101</emdnCode>
    <emdnDescription>PTCA BALLOON DILATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PS45027</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-06-30T23:52:34.169Z</lastUpdated>
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    <udiDi>08699343627009</udiDi>
    <basicUdiDi>86993436PTCASC89</basicUdiDi>
    <tradeName>Simpass</tradeName>
    <deviceName>Simpass Plus RX PTCA Balloon Dilatation Catheter</deviceName>
    <manufacturerName>Simeks Tibbi Urunler San. ve Tic LTD STI</manufacturerName>
    <manufacturerSrn>TR-MF-000015871</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C010401020101</emdnCode>
    <emdnDescription>PTCA BALLOON DILATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PS45024</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-06-30T23:52:32.970Z</lastUpdated>
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    <udiDi>08699343626996</udiDi>
    <basicUdiDi>86993436PTCASC89</basicUdiDi>
    <tradeName>Simpass</tradeName>
    <deviceName>Simpass Plus RX PTCA Balloon Dilatation Catheter</deviceName>
    <manufacturerName>Simeks Tibbi Urunler San. ve Tic LTD STI</manufacturerName>
    <manufacturerSrn>TR-MF-000015871</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C010401020101</emdnCode>
    <emdnDescription>PTCA BALLOON DILATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PS45022</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-06-30T23:52:26.963Z</lastUpdated>
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    <udiDi>08699343626989</udiDi>
    <basicUdiDi>86993436PTCASC89</basicUdiDi>
    <tradeName>Simpass</tradeName>
    <deviceName>Simpass Plus RX PTCA Balloon Dilatation Catheter</deviceName>
    <manufacturerName>Simeks Tibbi Urunler San. ve Tic LTD STI</manufacturerName>
    <manufacturerSrn>TR-MF-000015871</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C010401020101</emdnCode>
    <emdnDescription>PTCA BALLOON DILATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PS45018</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-06-30T23:52:25.764Z</lastUpdated>
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    <udiDi>08699343626972</udiDi>
    <basicUdiDi>86993436PTCASC89</basicUdiDi>
    <tradeName>Simpass</tradeName>
    <deviceName>Simpass Plus RX PTCA Balloon Dilatation Catheter</deviceName>
    <manufacturerName>Simeks Tibbi Urunler San. ve Tic LTD STI</manufacturerName>
    <manufacturerSrn>TR-MF-000015871</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C010401020101</emdnCode>
    <emdnDescription>PTCA BALLOON DILATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PS40042</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-06-30T23:52:24.562Z</lastUpdated>
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    <udiDi>08699343626965</udiDi>
    <basicUdiDi>86993436PTCASC89</basicUdiDi>
    <tradeName>Simpass</tradeName>
    <deviceName>Simpass Plus RX PTCA Balloon Dilatation Catheter</deviceName>
    <manufacturerName>Simeks Tibbi Urunler San. ve Tic LTD STI</manufacturerName>
    <manufacturerSrn>TR-MF-000015871</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C010401020101</emdnCode>
    <emdnDescription>PTCA BALLOON DILATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PS40024</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-06-30T23:52:23.364Z</lastUpdated>
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    <udiDi>08699343626958</udiDi>
    <basicUdiDi>86993436PTCASC89</basicUdiDi>
    <tradeName>Simpass</tradeName>
    <deviceName>Simpass Plus RX PTCA Balloon Dilatation Catheter</deviceName>
    <manufacturerName>Simeks Tibbi Urunler San. ve Tic LTD STI</manufacturerName>
    <manufacturerSrn>TR-MF-000015871</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C010401020101</emdnCode>
    <emdnDescription>PTCA BALLOON DILATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PS35042</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-06-30T23:52:17.362Z</lastUpdated>
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    <udiDi>08699343626941</udiDi>
    <basicUdiDi>86993436PTCASC89</basicUdiDi>
    <tradeName>Simpass</tradeName>
    <deviceName>Simpass Plus RX PTCA Balloon Dilatation Catheter</deviceName>
    <manufacturerName>Simeks Tibbi Urunler San. ve Tic LTD STI</manufacturerName>
    <manufacturerSrn>TR-MF-000015871</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C010401020101</emdnCode>
    <emdnDescription>PTCA BALLOON DILATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PS35024</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-06-30T23:52:16.161Z</lastUpdated>
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    <udiDi>08699343626934</udiDi>
    <basicUdiDi>86993436PTCASC89</basicUdiDi>
    <tradeName>Simpass</tradeName>
    <deviceName>Simpass Plus RX PTCA Balloon Dilatation Catheter</deviceName>
    <manufacturerName>Simeks Tibbi Urunler San. ve Tic LTD STI</manufacturerName>
    <manufacturerSrn>TR-MF-000015871</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C010401020101</emdnCode>
    <emdnDescription>PTCA BALLOON DILATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PS32542</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-06-30T23:52:14.955Z</lastUpdated>
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    <udiDi>08699343626927</udiDi>
    <basicUdiDi>86993436PTCASC89</basicUdiDi>
    <tradeName>Simpass</tradeName>
    <deviceName>Simpass Plus RX PTCA Balloon Dilatation Catheter</deviceName>
    <manufacturerName>Simeks Tibbi Urunler San. ve Tic LTD STI</manufacturerName>
    <manufacturerSrn>TR-MF-000015871</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C010401020101</emdnCode>
    <emdnDescription>PTCA BALLOON DILATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PS32524</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-06-30T23:52:13.754Z</lastUpdated>
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    <udiDi>08699343626910</udiDi>
    <basicUdiDi>86993436PTCASC89</basicUdiDi>
    <tradeName>Simpass</tradeName>
    <deviceName>Simpass Plus RX PTCA Balloon Dilatation Catheter</deviceName>
    <manufacturerName>Simeks Tibbi Urunler San. ve Tic LTD STI</manufacturerName>
    <manufacturerSrn>TR-MF-000015871</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C010401020101</emdnCode>
    <emdnDescription>PTCA BALLOON DILATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PS30042</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-06-30T23:52:07.752Z</lastUpdated>
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    <udiDi>08699343626903</udiDi>
    <basicUdiDi>86993436PTCASC89</basicUdiDi>
    <tradeName>Simpass</tradeName>
    <deviceName>Simpass Plus RX PTCA Balloon Dilatation Catheter</deviceName>
    <manufacturerName>Simeks Tibbi Urunler San. ve Tic LTD STI</manufacturerName>
    <manufacturerSrn>TR-MF-000015871</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C010401020101</emdnCode>
    <emdnDescription>PTCA BALLOON DILATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PS30024</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-06-30T23:52:06.551Z</lastUpdated>
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    <udiDi>08699343626897</udiDi>
    <basicUdiDi>86993436PTCASC89</basicUdiDi>
    <tradeName>Simpass</tradeName>
    <deviceName>Simpass Plus RX PTCA Balloon Dilatation Catheter</deviceName>
    <manufacturerName>Simeks Tibbi Urunler San. ve Tic LTD STI</manufacturerName>
    <manufacturerSrn>TR-MF-000015871</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C010401020101</emdnCode>
    <emdnDescription>PTCA BALLOON DILATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PS27542</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-06-30T23:52:05.350Z</lastUpdated>
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    <udiDi>08699343626880</udiDi>
    <basicUdiDi>86993436PTCASC89</basicUdiDi>
    <tradeName>Simpass</tradeName>
    <deviceName>Simpass Plus RX PTCA Balloon Dilatation Catheter</deviceName>
    <manufacturerName>Simeks Tibbi Urunler San. ve Tic LTD STI</manufacturerName>
    <manufacturerSrn>TR-MF-000015871</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C010401020101</emdnCode>
    <emdnDescription>PTCA BALLOON DILATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PS27524</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-06-30T23:52:04.154Z</lastUpdated>
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    <udiDi>08699343626873</udiDi>
    <basicUdiDi>86993436PTCASC89</basicUdiDi>
    <tradeName>Simpass</tradeName>
    <deviceName>Simpass Plus RX PTCA Balloon Dilatation Catheter</deviceName>
    <manufacturerName>Simeks Tibbi Urunler San. ve Tic LTD STI</manufacturerName>
    <manufacturerSrn>TR-MF-000015871</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C010401020101</emdnCode>
    <emdnDescription>PTCA BALLOON DILATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PS25042</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-06-30T23:51:58.147Z</lastUpdated>
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