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    <manufacturerName>Urotronic, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000011144</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U0399</emdnCode>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>1110-06050C</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:24:16.311Z</lastUpdated>
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    <basicUdiDi>B-00853095008792</basicUdiDi>
    <tradeName>Optilume</tradeName>
    <deviceName>Optilume</deviceName>
    <manufacturerName>Urotronic, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000011144</manufacturerSrn>
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    <emdnCode>U0399</emdnCode>
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    <reference>1110-08030C</reference>
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    <udiDi>00853095008785</udiDi>
    <basicUdiDi>B-00853095008785</basicUdiDi>
    <tradeName>Optilume</tradeName>
    <deviceName>Optilume</deviceName>
    <manufacturerName>Urotronic, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000011144</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
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    <legislation>MDD</legislation>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>1110-08050C</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:23:57.836Z</lastUpdated>
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    <basicUdiDi>B-00853095008778</basicUdiDi>
    <tradeName>Optilume</tradeName>
    <deviceName>Optilume</deviceName>
    <manufacturerName>Urotronic, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000011144</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U0399</emdnCode>
    <emdnDescription>DEVICES FOR URINARY TRACT DILATION - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1110-10050C</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:23:56.238Z</lastUpdated>
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    <udiDi>00853095008761</udiDi>
    <basicUdiDi>B-00853095008761</basicUdiDi>
    <tradeName>Optilume</tradeName>
    <deviceName>Optilume</deviceName>
    <manufacturerName>Urotronic, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000011144</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U0399</emdnCode>
    <emdnDescription>DEVICES FOR URINARY TRACT DILATION - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1110-10030C</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:23:55.453Z</lastUpdated>
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    <udiDi>08964003662509</udiDi>
    <basicUdiDi>8964003662UDN4</basicUdiDi>
    <tradeName>Uterine Dilators</tradeName>
    <deviceName>Uterine Dilators</deviceName>
    <manufacturerName>CENTRAL SURGICAL Co. (PVT) LTD.</manufacturerName>
    <manufacturerSrn>PK-MF-000035590</manufacturerSrn>
    <authorisedRepresentativeName>KHANG BAO INTERNATIONAL KFT</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>HU-AR-000034102</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U03010202</emdnCode>
    <emdnDescription>URETERAL DILATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>UD</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-03T20:08:15.889Z</lastUpdated>
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    <udiDi>08964001697749</udiDi>
    <basicUdiDi>89640016976485089UA</basicUdiDi>
    <tradeName>Sahil Surgical (Pvt) Ltd</tradeName>
    <deviceName>Dilator Hegar 19 Y 20</deviceName>
    <manufacturerName>Sahil Surgical (Pvt.) Ltd</manufacturerName>
    <manufacturerSrn>PK-MF-000047528</manufacturerSrn>
    <authorisedRepresentativeName>KHANG BAO INTERNATIONAL KFT</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>HU-AR-000034102</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U03010201</emdnCode>
    <emdnDescription>URETHRAL DILATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6485089</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-03T19:56:41.322Z</lastUpdated>
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    <udiDi>08964001697732</udiDi>
    <basicUdiDi>89640016976485088U8</basicUdiDi>
    <tradeName>Sahil Surgical (Pvt) Ltd</tradeName>
    <deviceName>Dilator Hegar 17 Y 18</deviceName>
    <manufacturerName>Sahil Surgical (Pvt.) Ltd</manufacturerName>
    <manufacturerSrn>PK-MF-000047528</manufacturerSrn>
    <authorisedRepresentativeName>KHANG BAO INTERNATIONAL KFT</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>HU-AR-000034102</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U03010201</emdnCode>
    <emdnDescription>URETHRAL DILATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6485088</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-03T19:56:37.328Z</lastUpdated>
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    <udiDi>08964001697725</udiDi>
    <basicUdiDi>89640016976485086U4</basicUdiDi>
    <tradeName>Sahil Surgical (Pvt) Ltd</tradeName>
    <deviceName>Dilator Hegar 13 Y 14</deviceName>
    <manufacturerName>Sahil Surgical (Pvt.) Ltd</manufacturerName>
    <manufacturerSrn>PK-MF-000047528</manufacturerSrn>
    <authorisedRepresentativeName>KHANG BAO INTERNATIONAL KFT</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>HU-AR-000034102</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U03010201</emdnCode>
    <emdnDescription>URETHRAL DILATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6485086</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-03T19:56:36.528Z</lastUpdated>
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    <udiDi>08964001697718</udiDi>
    <basicUdiDi>89640016976485083TW</basicUdiDi>
    <tradeName>Sahil Surgical (Pvt) Ltd</tradeName>
    <deviceName>Dilator Hegar 7 Y 8</deviceName>
    <manufacturerName>Sahil Surgical (Pvt.) Ltd</manufacturerName>
    <manufacturerSrn>PK-MF-000047528</manufacturerSrn>
    <authorisedRepresentativeName>KHANG BAO INTERNATIONAL KFT</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>HU-AR-000034102</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U03010201</emdnCode>
    <emdnDescription>URETHRAL DILATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6485083</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-03T19:56:35.725Z</lastUpdated>
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    <udiDi>08964001697701</udiDi>
    <basicUdiDi>89640016976485082TU</basicUdiDi>
    <tradeName>Sahil Surgical (Pvt) Ltd</tradeName>
    <deviceName>Dilator Hegar 5 Y 6</deviceName>
    <manufacturerName>Sahil Surgical (Pvt.) Ltd</manufacturerName>
    <manufacturerSrn>PK-MF-000047528</manufacturerSrn>
    <authorisedRepresentativeName>KHANG BAO INTERNATIONAL KFT</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>HU-AR-000034102</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U03010201</emdnCode>
    <emdnDescription>URETHRAL DILATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6485082</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-03T19:56:34.923Z</lastUpdated>
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    <udiDi>08964001697695</udiDi>
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    <tradeName>Sahil Surgical (Pvt) Ltd</tradeName>
    <deviceName>Dilator Hegar 1 Y 2</deviceName>
    <manufacturerName>Sahil Surgical (Pvt.) Ltd</manufacturerName>
    <manufacturerSrn>PK-MF-000047528</manufacturerSrn>
    <authorisedRepresentativeName>KHANG BAO INTERNATIONAL KFT</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>HU-AR-000034102</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U03010201</emdnCode>
    <emdnDescription>URETHRAL DILATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6485080</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-03T19:56:30.923Z</lastUpdated>
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    <udiDi>08964001697688</udiDi>
    <basicUdiDi>89640016976485091TV</basicUdiDi>
    <tradeName>Sahil Surgical (Pvt) Ltd</tradeName>
    <deviceName>Dilator Hegar 23 Y 24</deviceName>
    <manufacturerName>Sahil Surgical (Pvt.) Ltd</manufacturerName>
    <manufacturerSrn>PK-MF-000047528</manufacturerSrn>
    <authorisedRepresentativeName>KHANG BAO INTERNATIONAL KFT</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>HU-AR-000034102</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U03010201</emdnCode>
    <emdnDescription>URETHRAL DILATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6485091</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-03T19:56:30.121Z</lastUpdated>
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    <udiDi>08961103940018</udiDi>
    <basicUdiDi>896110394Bi15-717LU</basicUdiDi>
    <tradeName>Guyon bougies set</tradeName>
    <deviceName>Guyon bougies set</deviceName>
    <manufacturerName>Battan International</manufacturerName>
    <manufacturerSrn>PK-MF-000043557</manufacturerSrn>
    <authorisedRepresentativeName>KHANG BAO INTERNATIONAL KFT</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>HU-AR-000034102</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U03010201</emdnCode>
    <emdnDescription>URETHRAL DILATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Bi15-717</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-03T19:36:45.366Z</lastUpdated>
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    <udiDi>08905080008316</udiDi>
    <basicUdiDi>8905080BUAGS</basicUdiDi>
    <tradeName>Praveza ® Ureteral Access Sheath</tradeName>
    <deviceName>Ureteral Access Sheath</deviceName>
    <manufacturerName>Blue Neem Medical Devices Private Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000021793</manufacturerSrn>
    <authorisedRepresentativeName>Arazy Group (Ireland) Ltd.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000093</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U03010202</emdnCode>
    <emdnDescription>URETERAL DILATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BUAB09502800</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-03T18:34:19.577Z</lastUpdated>
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    <udiDi>08905080000686</udiDi>
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    <tradeName>Fascial Dilator</tradeName>
    <deviceName>Percutaneous Dilators</deviceName>
    <manufacturerName>Blue Neem Medical Devices Private Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000021793</manufacturerSrn>
    <authorisedRepresentativeName>Arazy Group (Ireland) Ltd.</authorisedRepresentativeName>
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    <legislation>MDR 2017/745</legislation>
    <emdnCode>U03010199</emdnCode>
    <emdnDescription>PERCUTANEOUS NEPHROSTOMY, SEQUENTIAL DILATORS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BFDN0060200S</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-03T18:34:15.573Z</lastUpdated>
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    <tradeName>89041335572524</tradeName>
    <deviceName>Amplatz Sheath</deviceName>
    <manufacturerName>Aster Medispro Private Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000013179</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U03010101</emdnCode>
    <emdnDescription>AMPLATZ CANNULAS FOR URINARY DILATION</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AMPL-CA-GP-001-R0</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-03T18:30:45.053Z</lastUpdated>
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    <deviceName>Amplatz Sheath</deviceName>
    <manufacturerName>Aster Medispro Private Limited</manufacturerName>
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    <emdnDescription>AMPLATZ CANNULAS FOR URINARY DILATION</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AMPL-CA-GP-001-R0</reference>
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    <lastUpdated>2026-07-03T18:30:44.186Z</lastUpdated>
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    <deviceName>Amplatz Sheath</deviceName>
    <manufacturerName>Aster Medispro Private Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000013179</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
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    <emdnDescription>AMPLATZ CANNULAS FOR URINARY DILATION</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AMPL-CA-GP-001-R0</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-03T18:30:42.571Z</lastUpdated>
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    <tradeName>89041335572210</tradeName>
    <deviceName>Amplatz Sheath</deviceName>
    <manufacturerName>Aster Medispro Private Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000013179</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
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    <riskClass>Sınıf IIa</riskClass>
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    <emdnDescription>AMPLATZ CANNULAS FOR URINARY DILATION</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AMPL-CA-GP-001-R0</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-03T18:30:41.787Z</lastUpdated>
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