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    <basicUdiDi>735007844alarmsystemEG</basicUdiDi>
    <tradeName>Pjama</tradeName>
    <deviceName>Pjama Bedwetting Alarm System</deviceName>
    <manufacturerName>Pjama AB</manufacturerName>
    <manufacturerSrn>SE-MF-000016973</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U070299</emdnCode>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>9032</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-31T19:01:41.516Z</lastUpdated>
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    <udiDi>06946680198429</udiDi>
    <basicUdiDi>69466801GR-NT-GN3L</basicUdiDi>
    <tradeName>Male External Catheter</tradeName>
    <deviceName>Male External Catheter</deviceName>
    <manufacturerName>Ningbo Greatcare Medical Instruments Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000013677</manufacturerSrn>
    <authorisedRepresentativeName>Greatcare Medical GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005587</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U070201</emdnCode>
    <emdnDescription>SHEATH CATHETER FOR THE TREATMENT OF INCONTINENCE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>UZ6311</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-31T17:12:12.636Z</lastUpdated>
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    <udiDi>06925816649622</udiDi>
    <basicUdiDi>69449327FF03A0030LL</basicUdiDi>
    <tradeName>Urimed® Vision  Male External Catehter</tradeName>
    <deviceName>Male External Catheter</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 I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U070201</emdnCode>
    <emdnDescription>SHEATH CATHETER FOR THE TREATMENT OF INCONTINENCE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2962515A</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T16:58:08.015Z</lastUpdated>
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    <udiDi>00610075973255</udiDi>
    <basicUdiDi>610075D01P030S00606H</basicUdiDi>
    <tradeName>Hollister</tradeName>
    <deviceName>Male Incontinence Sheath (Catheter)</deviceName>
    <manufacturerName>Hollister Incorporated</manufacturerName>
    <manufacturerSrn>US-MF-000027818</manufacturerSrn>
    <authorisedRepresentativeName>Hollister ULC</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000022119</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U070201</emdnCode>
    <emdnDescription>SHEATH CATHETER FOR THE TREATMENT OF INCONTINENCE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>97325</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T13:44:38.893Z</lastUpdated>
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    <udiDi>05999542973642</udiDi>
    <basicUdiDi>599954297GM0930QF</basicUdiDi>
    <tradeName>GM felnőtt nadrágpelenka S (1200 ml)</tradeName>
    <deviceName>VIZELETFELSZÍVÓ ÉS DEFEKÁLÁSI SEGÉDESZKÖZÖK</deviceName>
    <manufacturerName>PATELLA-96 Kereskedelmi és Szolgáltató Korlátolt Felelősségű Társaság</manufacturerName>
    <manufacturerSrn>HU-MF-000004588</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U070299</emdnCode>
    <emdnDescription>EXTERNAL DEVICES FOR THE TREATMENT OF INCONTINENCE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GM felnőtt nadrágpelenka S (1200 ml)</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-31T13:38:04.524Z</lastUpdated>
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    <udiDi>05999542971624</udiDi>
    <basicUdiDi>599954297GM0940QJ</basicUdiDi>
    <tradeName>GM betegalátét 40x60 cm</tradeName>
    <deviceName>BETEGALÁTÉTEK</deviceName>
    <manufacturerName>PATELLA-96 Kereskedelmi és Szolgáltató Korlátolt Felelősségű Társaság</manufacturerName>
    <manufacturerSrn>HU-MF-000004588</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U070201</emdnCode>
    <emdnDescription>SHEATH CATHETER FOR THE TREATMENT OF INCONTINENCE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GM egyszerhasználatos antidecubitus alátét 40x60 cm</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-31T13:37:55.242Z</lastUpdated>
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    <udiDi>05033435070039</udiDi>
    <basicUdiDi>5033435K00030Z7</basicUdiDi>
    <tradeName>iTouch Sure</tradeName>
    <deviceName>iTouch Sure 2</deviceName>
    <manufacturerName>TensCare Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000004156</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U070399</emdnCode>
    <emdnDescription>PELVIC FLOOR REHABILITATION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>K-ITS</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-31T09:37:03.197Z</lastUpdated>
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    <udiDi>05033435130825</udiDi>
    <basicUdiDi>5033435K00072ZP</basicUdiDi>
    <tradeName>Sure PRO</tradeName>
    <deviceName>Sure PRO</deviceName>
    <manufacturerName>TensCare Ltd</manufacturerName>
    <manufacturerSrn>UK-PR-000039358</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U070399</emdnCode>
    <emdnDescription>PELVIC FLOOR REHABILITATION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>K-SP</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-31T09:37:02.945Z</lastUpdated>
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  <row>
    <udiDi>05033435132188</udiDi>
    <basicUdiDi>5033435K00053ZK</basicUdiDi>
    <tradeName>Perfect PFE</tradeName>
    <deviceName>Perfect PFE</deviceName>
    <manufacturerName>TensCare Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000004156</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U070399</emdnCode>
    <emdnDescription>PELVIC FLOOR REHABILITATION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>K-PPFE</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-31T09:37:02.661Z</lastUpdated>
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  <row>
    <udiDi>05033435132362</udiDi>
    <basicUdiDi>5033435K00025ZE</basicUdiDi>
    <tradeName>05033435132362</tradeName>
    <deviceName>iTouch Sure 2</deviceName>
    <manufacturerName>TensCare Ltd</manufacturerName>
    <manufacturerSrn>UK-PR-000039358</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U070399</emdnCode>
    <emdnDescription>PELVIC FLOOR REHABILITATION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>K-ITS-GO</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-31T09:37:02.480Z</lastUpdated>
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  <row>
    <udiDi>05033435132768</udiDi>
    <basicUdiDi>5033435K00053ZK</basicUdiDi>
    <tradeName>Pelvi+</tradeName>
    <deviceName></deviceName>
    <manufacturerName>TensCare Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000004156</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>U070399</emdnCode>
    <emdnDescription>PELVIC FLOOR REHABILITATION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>K-PELVI</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-31T09:37:02.438Z</lastUpdated>
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  <row>
    <udiDi>05033435132966</udiDi>
    <basicUdiDi>5033435K00051ZF</basicUdiDi>
    <tradeName>Perfect PFE for men</tradeName>
    <deviceName>Perfect PFE</deviceName>
    <manufacturerName>TensCare Ltd</manufacturerName>
    <manufacturerSrn>UK-PR-000039358</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U070399</emdnCode>
    <emdnDescription>PELVIC FLOOR REHABILITATION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>K-PPFE-MEN NORDIC</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-31T09:37:02.405Z</lastUpdated>
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    <udiDi>05033435133543</udiDi>
    <basicUdiDi>5033435K00053ZK</basicUdiDi>
    <tradeName>Perfect PFE (Latin)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>TensCare Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000004156</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>U070399</emdnCode>
    <emdnDescription>PELVIC FLOOR REHABILITATION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>K-PPFE-LATIN</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-31T09:37:02.257Z</lastUpdated>
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    <udiDi>05033435134007</udiDi>
    <basicUdiDi>5033435K00053ZK</basicUdiDi>
    <tradeName>Perfect PFE (Nordic)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>TensCare Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000004156</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>U070399</emdnCode>
    <emdnDescription>PELVIC FLOOR REHABILITATION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>K-PPFE-NORDIC</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-31T09:37:02.214Z</lastUpdated>
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    <udiDi>05033435134014</udiDi>
    <basicUdiDi>5033435K00051ZF</basicUdiDi>
    <tradeName>Perfect PFE for men (Nordic)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>TensCare Ltd</manufacturerName>
    <manufacturerSrn>UK-PR-000039358</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>U070399</emdnCode>
    <emdnDescription>PELVIC FLOOR REHABILITATION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>K-PPFE-MEN NORDIC</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-31T09:37:02.184Z</lastUpdated>
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    <udiDi>05033435134021</udiDi>
    <basicUdiDi>5033435K00053ZK</basicUdiDi>
    <tradeName>Kegel Toner</tradeName>
    <deviceName></deviceName>
    <manufacturerName>TensCare Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000004156</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>U070399</emdnCode>
    <emdnDescription>PELVIC FLOOR REHABILITATION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>K-KT</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T09:37:02.147Z</lastUpdated>
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    <udiDi>05033435134274</udiDi>
    <basicUdiDi>5033435K00106ZF</basicUdiDi>
    <tradeName>Elise 2</tradeName>
    <deviceName>Elise 2</deviceName>
    <manufacturerName>TensCare Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000004156</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U070399</emdnCode>
    <emdnDescription>PELVIC FLOOR REHABILITATION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>K-EL2</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T09:37:01.936Z</lastUpdated>
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    <udiDi>05033435135431</udiDi>
    <basicUdiDi>5033435K00030Z7</basicUdiDi>
    <tradeName>iTouch Sure 2 (Nordic)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>TensCare Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000004156</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>U070399</emdnCode>
    <emdnDescription>PELVIC FLOOR REHABILITATION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>K-ITS-NORDIC</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-31T09:37:01.846Z</lastUpdated>
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    <udiDi>05033435135646</udiDi>
    <basicUdiDi>5033435K00130ZC</basicUdiDi>
    <tradeName>Unicare</tradeName>
    <deviceName>Unicare</deviceName>
    <manufacturerName>TensCare Ltd</manufacturerName>
    <manufacturerSrn>UK-PR-000039358</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U070399</emdnCode>
    <emdnDescription>PELVIC FLOOR REHABILITATION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>K-UNICARE</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-31T09:37:01.438Z</lastUpdated>
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    <udiDi>05704101500128</udiDi>
    <basicUdiDi>5704101500124Q</basicUdiDi>
    <tradeName>Bulkamid® Urethral Bulking System</tradeName>
    <deviceName>Bulkamid® Urethral Bulking System</deviceName>
    <manufacturerName>Contura International A/S</manufacturerName>
    <manufacturerSrn>DK-PR-000002019</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U070199</emdnCode>
    <emdnDescription>INTERNAL SYSTEMS FOR THE TREATMENT OF INCONTINENCE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>50012</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-31T08:58:47.937Z</lastUpdated>
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