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<eudamedExport entity="devices">
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    <basicUdiDi>8033860KYPFT05A9T</basicUdiDi>
    <tradeName>RENOVA SPINE BALLOON CATHETER</tradeName>
    <deviceName>KYPHOPLASTY SYSTEMS</deviceName>
    <manufacturerName>BIOPSYBELL SRL</manufacturerName>
    <manufacturerSrn>IT-MF-000011601</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>K010301</emdnCode>
    <emdnDescription>SPINAL PERCUTANEOUS PLASTIC DEVICES WITH BALLOON</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RESB10PM</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-31T19:11:10.291Z</lastUpdated>
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    <udiDi>08033638800324</udiDi>
    <basicUdiDi>803363880ANSCPSTPK</basicUdiDi>
    <tradeName>SELF-LED-LIGHT</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SAPI MED S.p.A.</manufacturerName>
    <manufacturerSrn>IT-MF-000023733</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>G02060301</emdnCode>
    <emdnDescription>ANOSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A.4018LST</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-31T19:10:56.861Z</lastUpdated>
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    <udiDi>05944702208850</udiDi>
    <basicUdiDi>805574884FTKMDR14ET</basicUdiDi>
    <tradeName>Kebene Pro Baby</tradeName>
    <deviceName>COMIL</deviceName>
    <manufacturerName>Gruppo Farmaimpresa srl</manufacturerName>
    <manufacturerSrn>IT-PR-000036632</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>G0401</emdnCode>
    <emdnDescription>ORALLY ADMINISTERED DEVICES FOR THE THERAPY OF GASTRO-INTESTINAL DISORDERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FT.K.MDR.14.5</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-31T19:10:01.471Z</lastUpdated>
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    <udiDi>00701197198142</udiDi>
    <basicUdiDi>805574884FTCE16-267U</basicUdiDi>
    <tradeName>METICOL 20 ml</tradeName>
    <deviceName>RILEX GTT 20ml</deviceName>
    <manufacturerName>GRUPPO FARMAIMPRESA SRL</manufacturerName>
    <manufacturerSrn>IT-MF-000012625</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>G99</emdnCode>
    <emdnDescription>GASTROINTESTINAL DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FT.MDR.26</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-31T19:08:51.676Z</lastUpdated>
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    <udiDi>07630030856389</udiDi>
    <basicUdiDi>764014274VSP0142R00LE</basicUdiDi>
    <tradeName>Thoracic probe sleeve STERILE</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Medacta International SA</manufacturerName>
    <manufacturerSrn>CH-MF-000033473</manufacturerSrn>
    <authorisedRepresentativeName>Medacta Italia srl</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000022505</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>K01020114</emdnCode>
    <emdnDescription>MINIMALLY INVASIVE SURGERY GUIDES, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>7.0050S</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-31T19:02:03.167Z</lastUpdated>
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  <row>
    <udiDi>07333387047430</udiDi>
    <basicUdiDi>733338724104D3</basicUdiDi>
    <tradeName>Navina Mini Set</tradeName>
    <deviceName>Navina, Bowel Management System</deviceName>
    <manufacturerName>Wellspect HealthCare</manufacturerName>
    <manufacturerSrn>SE-MF-000026271</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>G020199</emdnCode>
    <emdnDescription>GASTROINTESTINAL LAVAGE, TUBES AND SETS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6930730</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-31T19:01:35.611Z</lastUpdated>
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  <row>
    <udiDi>05011417807187</udiDi>
    <basicUdiDi>7649993626FT42306VN</basicUdiDi>
    <tradeName>Fybocalm Wind &amp; Bloating relief</tradeName>
    <deviceName>Sectacol</deviceName>
    <manufacturerName>DEVINTEC SAGL</manufacturerName>
    <manufacturerSrn>CH-MF-000020271</manufacturerSrn>
    <authorisedRepresentativeName>DEVINTEC HEALTH S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000020256</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>G0401</emdnCode>
    <emdnDescription>ORALLY ADMINISTERED DEVICES FOR THE THERAPY OF GASTRO-INTESTINAL DISORDERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C12B02E030</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T18:59:10.154Z</lastUpdated>
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  <row>
    <udiDi>05011417807170</udiDi>
    <basicUdiDi>7649993626FT42301VC</basicUdiDi>
    <tradeName>Fybocalm Diarrhoea Relief</tradeName>
    <deviceName>Gelsectan</deviceName>
    <manufacturerName>DEVINTEC SAGL</manufacturerName>
    <manufacturerSrn>CH-MF-000020271</manufacturerSrn>
    <authorisedRepresentativeName>DEVINTEC HEALTH S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000020256</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>G0401</emdnCode>
    <emdnDescription>ORALLY ADMINISTERED DEVICES FOR THE THERAPY OF GASTRO-INTESTINAL DISORDERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C05B02E030</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T18:59:06.964Z</lastUpdated>
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    <udiDi>05011417807163</udiDi>
    <basicUdiDi>7649993626FT42307VQ</basicUdiDi>
    <tradeName>Fybocalm Constipation relief</tradeName>
    <deviceName>Gelselax</deviceName>
    <manufacturerName>DEVINTEC SAGL</manufacturerName>
    <manufacturerSrn>CH-MF-000020271</manufacturerSrn>
    <authorisedRepresentativeName>DEVINTEC HEALTH S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000020256</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>G0401</emdnCode>
    <emdnDescription>ORALLY ADMINISTERED DEVICES FOR THE THERAPY OF GASTRO-INTESTINAL DISORDERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C20B02E030</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T18:59:06.236Z</lastUpdated>
  </row>
  <row>
    <udiDi>04150115563214</udiDi>
    <basicUdiDi>764012962MD-EnemaApplSL</basicUdiDi>
    <tradeName>04150115563214</tradeName>
    <deviceName>Enema Applicator</deviceName>
    <manufacturerName>Tillotts Pharma AG</manufacturerName>
    <manufacturerSrn>CH-MF-000044751</manufacturerSrn>
    <authorisedRepresentativeName>Tillotts Pharma GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000037376</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>G05</emdnCode>
    <emdnDescription>TOPICAL ANORECTAL ADMINISTERED GASTRO-INTESTINAL SYSTEM DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>32.141.962.10004</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T18:58:59.532Z</lastUpdated>
  </row>
  <row>
    <udiDi>07290108301892</udiDi>
    <basicUdiDi>729010142SBBFB</basicUdiDi>
    <tradeName>Soft BiteBlock</tradeName>
    <deviceName>Soft Biteblock™</deviceName>
    <manufacturerName>SION BIOTEXT MEDICAL LTD.</manufacturerName>
    <manufacturerSrn>IL-MF-000012169</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>G030804</emdnCode>
    <emdnDescription>GASTROINTESTINAL ENDOSCOPY AND ECHOENDOSCOPY, BITE BLOCKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>54D260-260000</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-31T18:55:37.603Z</lastUpdated>
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    <udiDi>06974794560009</udiDi>
    <basicUdiDi>697479456LE79</basicUdiDi>
    <tradeName>06974794560009</tradeName>
    <deviceName>Disposable Laparoscopic Scissors/Graspers</deviceName>
    <manufacturerName>Surgitools（Shanghai）Medical Instruments Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000055047</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>K01020102</emdnCode>
    <emdnDescription>MINIMALLY INVASIVE SURGERY SCISSORS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LES1450</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-31T18:43:23.715Z</lastUpdated>
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    <udiDi>06942127891793</udiDi>
    <basicUdiDi>697067138MS055J4</basicUdiDi>
    <tradeName>Multi-Stage Balloon Dilatation Catheter</tradeName>
    <deviceName>Multi-Stage Balloon Dilatation Catheter</deviceName>
    <manufacturerName>Alton (Shanghai) Medical Instruments Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012832</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>G03010199</emdnCode>
    <emdnDescription>GASTROINTESTINAL ENDOSCOPY, BALLOON CATHETERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AF-D0718TBC12/13.5/1555</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T18:18:09.860Z</lastUpdated>
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  <row>
    <udiDi>06936937789340</udiDi>
    <basicUdiDi>697189056da7U</basicUdiDi>
    <tradeName>Disposable Biopsy Valves</tradeName>
    <deviceName>Disposable Biopsy Valves</deviceName>
    <manufacturerName>Jiangsu Grit Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000036496</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>G0380</emdnCode>
    <emdnDescription>DIGESTIVE ENDOSCOPY DEVICES - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GM-GA-NP1</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T18:17:45.823Z</lastUpdated>
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    <udiDi>06936937789265</udiDi>
    <basicUdiDi>697189056ea7X</basicUdiDi>
    <tradeName>Disposable Bite Blocks</tradeName>
    <deviceName>Disposable Bite Blocks</deviceName>
    <manufacturerName>Jiangsu Grit Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000036496</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>G030804</emdnCode>
    <emdnDescription>GASTROINTESTINAL ENDOSCOPY AND ECHOENDOSCOPY, BITE BLOCKS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GM-KD-A1-D</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T18:17:45.029Z</lastUpdated>
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    <udiDi>06936603225882</udiDi>
    <basicUdiDi>69709008510117S</basicUdiDi>
    <tradeName>Hemoclip</tradeName>
    <deviceName>Hemoclips</deviceName>
    <manufacturerName>Yangzhou Fartley Medical Instrument Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000009371</manufacturerSrn>
    <authorisedRepresentativeName>Prolinx GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005129</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>G030202</emdnCode>
    <emdnDescription>DIGESTIVE ENDOSCOPY, HAEMOSTASIS CLIPS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>08032323012</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T18:17:17.768Z</lastUpdated>
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    <udiDi>06936603223901</udiDi>
    <basicUdiDi>697090085100987</basicUdiDi>
    <tradeName>Hybrid Polypectomy Snare</tradeName>
    <deviceName>Disposable Polypectomy Hybrid Snares</deviceName>
    <manufacturerName>Yangzhou Fartley Medical Instrument Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000009371</manufacturerSrn>
    <authorisedRepresentativeName>Prolinx GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005129</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>G03030199</emdnCode>
    <emdnDescription>POLYPECTOMY SNARES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HEX-HYB-24-03-10-230</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T18:17:13.761Z</lastUpdated>
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    <udiDi>06936603222447</udiDi>
    <basicUdiDi>697090085101888</basicUdiDi>
    <tradeName>EcoFlushCap</tradeName>
    <deviceName>Clean Connecting Tubes</deviceName>
    <manufacturerName>Yangzhou Fartley Medical Instrument Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000009371</manufacturerSrn>
    <authorisedRepresentativeName>Prolinx GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005129</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>G0280</emdnCode>
    <emdnDescription>GASTROINTESTINAL TUBES - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AC07-211.P</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T18:17:12.950Z</lastUpdated>
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    <udiDi>06936603221792</udiDi>
    <basicUdiDi>69709008510107Q</basicUdiDi>
    <tradeName>Disposable Polypectomy Cold Snares</tradeName>
    <deviceName>Disposable Polypectomy Cold Snare</deviceName>
    <manufacturerName>Yangzhou Fartley Medical Instrument Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000009371</manufacturerSrn>
    <authorisedRepresentativeName>Prolinx GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005129</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>G03030199</emdnCode>
    <emdnDescription>POLYPECTOMY SNARES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FTL-PSC-24-180-30-6-N</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T18:17:12.138Z</lastUpdated>
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    <udiDi>06936603220870</udiDi>
    <basicUdiDi>69709008510137W</basicUdiDi>
    <tradeName>Biopsy forceps</tradeName>
    <deviceName>Disposable Biopsy Forceps</deviceName>
    <manufacturerName>Yangzhou Fartley Medical Instrument Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000009371</manufacturerSrn>
    <authorisedRepresentativeName>Prolinx GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005129</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>G0308010101</emdnCode>
    <emdnDescription>GASTROINTESTINAL ENDOSCOPY, COLD BIOPSY FORCEPS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BP-40102</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T18:17:06.563Z</lastUpdated>
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