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    <tradeName>Latex Foley Catheter</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Well Lead Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000006728</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>U010299</emdnCode>
    <emdnDescription>URETHRAL PROSTATIC AND BLADDER CATHETERS, WITH BALLOON - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>F01A101612</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T02:09:58.122Z</lastUpdated>
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    <udiDi>06944932763821</udiDi>
    <basicUdiDi>69449327FF01A04E7</basicUdiDi>
    <tradeName>Latex Foley Catheter</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Well Lead Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000006728</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
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    <reference>F01A101805</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T02:09:58.100Z</lastUpdated>
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    <udiDi>06944932763838</udiDi>
    <basicUdiDi>69449327FF01A04E7</basicUdiDi>
    <tradeName>Latex Foley Catheter</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Well Lead Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000006728</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>U010299</emdnCode>
    <emdnDescription>URETHRAL PROSTATIC AND BLADDER CATHETERS, WITH BALLOON - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>F01A101806</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T02:09:58.076Z</lastUpdated>
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    <udiDi>06944932763852</udiDi>
    <basicUdiDi>69449327FF01A04E7</basicUdiDi>
    <tradeName>Latex Foley Catheter</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Well Lead Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000006728</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>U010299</emdnCode>
    <emdnDescription>URETHRAL PROSTATIC AND BLADDER CATHETERS, WITH BALLOON - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>F01A101812</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T02:09:58.052Z</lastUpdated>
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    <udiDi>06944932763883</udiDi>
    <basicUdiDi>69449327FF01A04E7</basicUdiDi>
    <tradeName>Latex Foley Catheter</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Well Lead Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000006728</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>U010299</emdnCode>
    <emdnDescription>URETHRAL PROSTATIC AND BLADDER CATHETERS, WITH BALLOON - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>F01A102005</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T02:09:58.026Z</lastUpdated>
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    <udiDi>06944932763890</udiDi>
    <basicUdiDi>69449327FF01A04E7</basicUdiDi>
    <tradeName>Latex Foley Catheter</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Well Lead Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000006728</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>U010299</emdnCode>
    <emdnDescription>URETHRAL PROSTATIC AND BLADDER CATHETERS, WITH BALLOON - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>F01A102006</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T02:09:58.006Z</lastUpdated>
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    <udiDi>06944932763913</udiDi>
    <basicUdiDi>69449327FF01A04E7</basicUdiDi>
    <tradeName>Latex Foley Catheter</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Well Lead Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000006728</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>U010299</emdnCode>
    <emdnDescription>URETHRAL PROSTATIC AND BLADDER CATHETERS, WITH BALLOON - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>F01A102012</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T02:09:57.980Z</lastUpdated>
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    <basicUdiDi>69449327FF01A04E7</basicUdiDi>
    <tradeName>Latex Foley Catheter</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Well Lead Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000006728</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
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    <emdnDescription>URETHRAL PROSTATIC AND BLADDER CATHETERS, WITH BALLOON - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>F01A102205</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T02:09:57.952Z</lastUpdated>
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    <udiDi>06944932763951</udiDi>
    <basicUdiDi>69449327FF01A04E7</basicUdiDi>
    <tradeName>Latex Foley Catheter</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Well Lead Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000006728</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>U010299</emdnCode>
    <emdnDescription>URETHRAL PROSTATIC AND BLADDER CATHETERS, WITH BALLOON - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>F01A102206</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T02:09:57.928Z</lastUpdated>
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    <udiDi>06944932763975</udiDi>
    <basicUdiDi>69449327FF01A04E7</basicUdiDi>
    <tradeName>Latex Foley Catheter</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Well Lead Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000006728</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>U010299</emdnCode>
    <emdnDescription>URETHRAL PROSTATIC AND BLADDER CATHETERS, WITH BALLOON - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>F01A102212</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T02:09:57.893Z</lastUpdated>
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    <udiDi>08907265107807</udiDi>
    <basicUdiDi>8907265A015YE</basicUdiDi>
    <tradeName>SILKO-CATH (2-WAY)</tradeName>
    <deviceName>Foley Balloon Catheter (Silicone)</deviceName>
    <manufacturerName>Romsons Group Private Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000036506</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U010299</emdnCode>
    <emdnDescription>URETHRAL PROSTATIC AND BLADDER CATHETERS, WITH BALLOON - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GS-1078</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-03T19:04:43.565Z</lastUpdated>
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    <udiDi>07333330108003</udiDi>
    <basicUdiDi>7333330FOLEYTIE120201WW</basicUdiDi>
    <tradeName>BIP Foley Tiemann Tip, 2-way 10 Fr 5cc</tradeName>
    <deviceName>BIP Foley Tiemann Tip</deviceName>
    <manufacturerName>Bactiguard AB</manufacturerName>
    <manufacturerSrn>SE-MF-000020790</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U010299</emdnCode>
    <emdnDescription>URETHRAL PROSTATIC AND BLADDER CATHETERS, WITH BALLOON - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>117100510</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-03T01:18:29.102Z</lastUpdated>
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  <row>
    <udiDi>07333330104692</udiDi>
    <basicUdiDi>7333330FOLEYLATUV110301Z9</basicUdiDi>
    <tradeName>BIP Foley Catheter 2-way, 8 Ch/Fr, 5ml/cc</tradeName>
    <deviceName>BIP Foley Catheter - Latex</deviceName>
    <manufacturerName>Bactiguard AB</manufacturerName>
    <manufacturerSrn>SE-MF-000020790</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U010299</emdnCode>
    <emdnDescription>URETHRAL PROSTATIC AND BLADDER CATHETERS, WITH BALLOON - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>111080310</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-03T01:18:28.301Z</lastUpdated>
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    <udiDi>07333330103824</udiDi>
    <basicUdiDi>7333330FOLEYSIL120101ZR</basicUdiDi>
    <tradeName>BIP Foley Catheter - Silicone, 2-way 6 Fr 3cc</tradeName>
    <deviceName>BIP Foley Catheter - Silicone</deviceName>
    <manufacturerName>Bactiguard AB</manufacturerName>
    <manufacturerSrn>SE-MF-000020790</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <legislation>MDR 2017/745</legislation>
    <emdnCode>U010299</emdnCode>
    <emdnDescription>URETHRAL PROSTATIC AND BLADDER CATHETERS, WITH BALLOON - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>115060510</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-03T01:18:26.671Z</lastUpdated>
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    <udiDi>06975883473026</udiDi>
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    <tradeName>06975883473026</tradeName>
    <deviceName>Sterile All Silicone Foley Catheter</deviceName>
    <manufacturerName>Hospital &amp; Homecare Medical Device Co., Ltd. China</manufacturerName>
    <manufacturerSrn>CN-MF-000032014</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
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    <emdnCode>U010299</emdnCode>
    <emdnDescription>URETHRAL PROSTATIC AND BLADDER CATHETERS, WITH BALLOON - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HK01a06</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-02T17:17:03.424Z</lastUpdated>
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    <udiDi>06975883473125</udiDi>
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    <tradeName>06975883473125</tradeName>
    <deviceName>Sterile All Silicone Foley Catheter</deviceName>
    <manufacturerName>Hospital &amp; Homecare Medical Device Co., Ltd. China</manufacturerName>
    <manufacturerSrn>CN-MF-000032014</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
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    <legislation>MDR 2017/745</legislation>
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    <emdnDescription>URETHRAL PROSTATIC AND BLADDER CATHETERS, WITH BALLOON - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HK0214</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-02T17:17:01.814Z</lastUpdated>
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    <udiDi>06975883473057</udiDi>
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    <tradeName>06975883473057</tradeName>
    <deviceName>Sterile All Silicone Foley Catheter</deviceName>
    <manufacturerName>Hospital &amp; Homecare Medical Device Co., Ltd. China</manufacturerName>
    <manufacturerSrn>CN-MF-000032014</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U010299</emdnCode>
    <emdnDescription>URETHRAL PROSTATIC AND BLADDER CATHETERS, WITH BALLOON - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HK01b12</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-02T17:17:01.123Z</lastUpdated>
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    <udiDi>06974589120074</udiDi>
    <basicUdiDi>697458912ST7L</basicUdiDi>
    <tradeName>Silicone Self-adhering Male External Catheters</tradeName>
    <deviceName>Silicone Self-adhering Male External Catheters</deviceName>
    <manufacturerName>Medalliance (Changzhou) Medical Instrument Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000032943</manufacturerSrn>
    <authorisedRepresentativeName>MedPath GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000087</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U010299</emdnCode>
    <emdnDescription>URETHRAL PROSTATIC AND BLADDER CATHETERS, WITH BALLOON - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MA510</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T13:39:24.037Z</lastUpdated>
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    <udiDi>06974589120029</udiDi>
    <basicUdiDi>697458912PO6Z</basicUdiDi>
    <tradeName>Silicone Self-adhering Male External Catheters</tradeName>
    <deviceName>Silicone Self-adhering Male External Catheters</deviceName>
    <manufacturerName>Medalliance (Changzhou) Medical Instrument Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000032943</manufacturerSrn>
    <authorisedRepresentativeName>MedPath GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000087</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U010299</emdnCode>
    <emdnDescription>URETHRAL PROSTATIC AND BLADDER CATHETERS, WITH BALLOON - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MA310</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T13:39:22.429Z</lastUpdated>
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  <row>
    <udiDi>03615370004694</udiDi>
    <basicUdiDi>697458912WB6U</basicUdiDi>
    <tradeName>Silicone Self-adhering Male External Catheters</tradeName>
    <deviceName>Silicone Self-adhering Male External Catheters</deviceName>
    <manufacturerName>Medalliance (Changzhou) Medical Instrument Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000032943</manufacturerSrn>
    <authorisedRepresentativeName>MedPath GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000087</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U010299</emdnCode>
    <emdnDescription>URETHRAL PROSTATIC AND BLADDER CATHETERS, WITH BALLOON - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MC24-30</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T13:34:33.227Z</lastUpdated>
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