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    <tradeName>Apexus</tradeName>
    <deviceName>Balloon Dilatation Catheter</deviceName>
    <manufacturerName>Polyrey Medical Tech(Suzhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000037473</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C010402020101</emdnCode>
    <emdnDescription>PTA BALLOON DILATATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>030-3000020</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-28T16:54:07.106Z</lastUpdated>
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    <tradeName>Apexus</tradeName>
    <deviceName>Balloon Dilatation Catheter</deviceName>
    <manufacturerName>Polyrey Medical Tech(Suzhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000037473</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
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    <legislation>MDD</legislation>
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    <tradeName>Apexus</tradeName>
    <deviceName>Balloon Dilatation Catheter</deviceName>
    <manufacturerName>Polyrey Medical Tech(Suzhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000037473</manufacturerSrn>
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    <tradeName>Apexus</tradeName>
    <deviceName>Balloon Dilatation Catheter</deviceName>
    <manufacturerName>Polyrey Medical Tech(Suzhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000037473</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
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    <emdnDescription>PTA BALLOON DILATATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>030-2500040</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-28T16:53:59.936Z</lastUpdated>
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    <basicUdiDi>B-06955454130077</basicUdiDi>
    <tradeName>Apexus</tradeName>
    <deviceName>Balloon Dilatation Catheter</deviceName>
    <manufacturerName>Polyrey Medical Tech(Suzhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000037473</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
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    <legislation>MDD</legislation>
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    <emdnDescription>PTA BALLOON DILATATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>030-2500020</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-28T16:53:57.518Z</lastUpdated>
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    <tradeName>Apexus</tradeName>
    <deviceName>Balloon Dilatation Catheter</deviceName>
    <manufacturerName>Polyrey Medical Tech(Suzhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000037473</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
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    <riskClass>Sınıf IIa</riskClass>
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    <emdnDescription>PTA BALLOON DILATATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>030-2000150</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-28T16:53:56.302Z</lastUpdated>
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    <tradeName>Apexus</tradeName>
    <deviceName>Balloon Dilatation Catheter</deviceName>
    <manufacturerName>Polyrey Medical Tech(Suzhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000037473</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
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    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C010402020101</emdnCode>
    <emdnDescription>PTA BALLOON DILATATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>030-2000080</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-28T16:53:53.904Z</lastUpdated>
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    <tradeName>Apexus</tradeName>
    <deviceName>Balloon Dilatation Catheter</deviceName>
    <manufacturerName>Polyrey Medical Tech(Suzhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000037473</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
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    <riskClass>Sınıf IIa</riskClass>
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    <emdnCode>C010402020101</emdnCode>
    <emdnDescription>PTA BALLOON DILATATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>030-2000040</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-28T16:53:50.290Z</lastUpdated>
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    <udiDi>06955454130039</udiDi>
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    <tradeName>Apexus</tradeName>
    <deviceName>Balloon Dilatation Catheter</deviceName>
    <manufacturerName>Polyrey Medical Tech(Suzhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000037473</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C010402020101</emdnCode>
    <emdnDescription>PTA BALLOON DILATATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>030-2000020</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-28T16:53:47.889Z</lastUpdated>
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    <udiDi>06955454122041</udiDi>
    <basicUdiDi>B-06955454122041</basicUdiDi>
    <tradeName>Apexus</tradeName>
    <deviceName>Balloon Dilatation Catheter</deviceName>
    <manufacturerName>Polyrey Medical Tech(Suzhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000037473</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C010402020101</emdnCode>
    <emdnDescription>PTA BALLOON DILATATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>022-3540200</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-28T16:53:47.579Z</lastUpdated>
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    <udiDi>06955454122034</udiDi>
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    <tradeName>Apexus</tradeName>
    <deviceName>Balloon Dilatation Catheter</deviceName>
    <manufacturerName>Polyrey Medical Tech(Suzhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000037473</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C010402020101</emdnCode>
    <emdnDescription>PTA BALLOON DILATATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>022-3035200</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-28T16:53:44.630Z</lastUpdated>
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    <udiDi>06955454122027</udiDi>
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    <tradeName>Apexus</tradeName>
    <deviceName>Balloon Dilatation Catheter</deviceName>
    <manufacturerName>Polyrey Medical Tech(Suzhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000037473</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C010402020101</emdnCode>
    <emdnDescription>PTA BALLOON DILATATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>022-2530200</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-28T16:53:40.686Z</lastUpdated>
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    <udiDi>06955454122010</udiDi>
    <basicUdiDi>B-06955454122010</basicUdiDi>
    <tradeName>Apexus</tradeName>
    <deviceName>Balloon Dilatation Catheter</deviceName>
    <manufacturerName>Polyrey Medical Tech(Suzhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000037473</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
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    <emdnCode>C010402020101</emdnCode>
    <emdnDescription>PTA BALLOON DILATATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>022-2025200</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-28T16:53:39.234Z</lastUpdated>
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    <udiDi>06955454120221</udiDi>
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    <tradeName>Apexus</tradeName>
    <deviceName>Balloon Dilatation Catheter</deviceName>
    <manufacturerName>Polyrey Medical Tech(Suzhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000037473</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
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    <emdnCode>C010402020101</emdnCode>
    <emdnDescription>PTA BALLOON DILATATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>020-4000150</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-28T16:53:37.104Z</lastUpdated>
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    <tradeName>Apexus</tradeName>
    <deviceName>Balloon Dilatation Catheter</deviceName>
    <manufacturerName>Polyrey Medical Tech(Suzhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000037473</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
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    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-28T16:53:34.712Z</lastUpdated>
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    <tradeName>Apexus</tradeName>
    <deviceName>Balloon Dilatation Catheter</deviceName>
    <manufacturerName>Polyrey Medical Tech(Suzhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000037473</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
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    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-28T16:53:31.079Z</lastUpdated>
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    <tradeName>Apexus</tradeName>
    <deviceName>Balloon Dilatation Catheter</deviceName>
    <manufacturerName>Polyrey Medical Tech(Suzhou) Co., Ltd.</manufacturerName>
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    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
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    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-28T16:53:28.682Z</lastUpdated>
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    <tradeName>Apexus</tradeName>
    <deviceName>Balloon Dilatation Catheter</deviceName>
    <manufacturerName>Polyrey Medical Tech(Suzhou) Co., Ltd.</manufacturerName>
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    <emdnCode>C010402020101</emdnCode>
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    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-28T16:53:27.479Z</lastUpdated>
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    <tradeName>Apexus</tradeName>
    <deviceName>Balloon Dilatation Catheter</deviceName>
    <manufacturerName>Polyrey Medical Tech(Suzhou) Co., Ltd.</manufacturerName>
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    <emdnCode>C010402020101</emdnCode>
    <emdnDescription>PTA BALLOON DILATATION CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>020-3500080</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-28T16:53:25.077Z</lastUpdated>
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    <tradeName>Apexus</tradeName>
    <deviceName>Balloon Dilatation Catheter</deviceName>
    <manufacturerName>Polyrey Medical Tech(Suzhou) Co., Ltd.</manufacturerName>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>020-3500040</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-28T16:53:21.487Z</lastUpdated>
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