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<eudamedExport entity="devices">
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    <udiDi>00627825003513</udiDi>
    <basicUdiDi>B-00627825003513</basicUdiDi>
    <tradeName>Aquarius Urodynamic System</tradeName>
    <deviceName>Aquarius Urodynamic System</deviceName>
    <manufacturerName>Laborie Medical Technologies Corp.</manufacturerName>
    <manufacturerSrn>US-MF-000022925</manufacturerSrn>
    <authorisedRepresentativeName>Medical Measurement Systems B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000010438</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12160401</emdnCode>
    <emdnDescription>URODYNAMICS SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AQS1000</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T14:22:02.171Z</lastUpdated>
  </row>
  <row>
    <udiDi>08717775955559</udiDi>
    <basicUdiDi>87177759500U2HG</basicUdiDi>
    <tradeName>Flowstar</tradeName>
    <deviceName>Flowstar</deviceName>
    <manufacturerName>Laborie Medical Technologies Corp.</manufacturerName>
    <manufacturerSrn>US-MF-000022925</manufacturerSrn>
    <authorisedRepresentativeName>Medical Measurement Systems B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000010438</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z121605</emdnCode>
    <emdnDescription>UROFLOWMETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>U2-1</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-03T16:23:13.779Z</lastUpdated>
  </row>
  <row>
    <udiDi>08717775954828</udiDi>
    <basicUdiDi>87177759500U1HE</basicUdiDi>
    <tradeName>Flowmaster</tradeName>
    <deviceName>Flowmaster</deviceName>
    <manufacturerName>Laborie Medical Technologies Corp.</manufacturerName>
    <manufacturerSrn>US-MF-000022925</manufacturerSrn>
    <authorisedRepresentativeName>Medical Measurement Systems B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000010438</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z121605</emdnCode>
    <emdnDescription>UROFLOWMETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>U1-1</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-03T16:23:12.968Z</lastUpdated>
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  <row>
    <udiDi>10627825007082</udiDi>
    <basicUdiDi>062782501N9</basicUdiDi>
    <tradeName>10627825007082</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Laborie Medical Technologies Corp.</manufacturerName>
    <manufacturerSrn>US-MF-000022925</manufacturerSrn>
    <authorisedRepresentativeName>Medical Measurement Systems B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000010438</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9021P5062</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T07:29:40.002Z</lastUpdated>
  </row>
  <row>
    <udiDi>00896984000316</udiDi>
    <basicUdiDi>087448500GuideSleeve83</basicUdiDi>
    <tradeName>Endoscope Light Guide Sleeve - Circon</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Cogentix Medical, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000041661</manufacturerSrn>
    <authorisedRepresentativeName>Medical Measurement Systems B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000010438</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>GENITOURINARY ENDOSCOPY INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>06-6019</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T02:35:49.157Z</lastUpdated>
  </row>
  <row>
    <udiDi>00896984000323</udiDi>
    <basicUdiDi>087448500GuideSleeve83</basicUdiDi>
    <tradeName>Endoscope Light Guide Sleeve - Karl Storz</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Cogentix Medical, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000041661</manufacturerSrn>
    <authorisedRepresentativeName>Medical Measurement Systems B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000010438</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>GENITOURINARY ENDOSCOPY INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>06-6023</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T02:35:49.138Z</lastUpdated>
  </row>
  <row>
    <udiDi>00896984000347</udiDi>
    <basicUdiDi>087448500GuideSleeve83</basicUdiDi>
    <tradeName>Endoscope Light Guide Sleeve - Olympus</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Cogentix Medical, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000041661</manufacturerSrn>
    <authorisedRepresentativeName>Medical Measurement Systems B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000010438</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>GENITOURINARY ENDOSCOPY INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>06-6044</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T02:35:49.115Z</lastUpdated>
  </row>
  <row>
    <udiDi>00896984000354</udiDi>
    <basicUdiDi>087448500GuideSleeve83</basicUdiDi>
    <tradeName>Endoscope Light Guide Sleeve - Pentax</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Cogentix Medical, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000041661</manufacturerSrn>
    <authorisedRepresentativeName>Medical Measurement Systems B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000010438</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>GENITOURINARY ENDOSCOPY INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>06-6009</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T02:35:49.104Z</lastUpdated>
  </row>
  <row>
    <udiDi>00896984000361</udiDi>
    <basicUdiDi>087448500GuideSleeve83</basicUdiDi>
    <tradeName>Endoscope Light Guide Sleeve - Wolf</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Cogentix Medical, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000041661</manufacturerSrn>
    <authorisedRepresentativeName>Medical Measurement Systems B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000010438</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>GENITOURINARY ENDOSCOPY INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>06-6020</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T02:35:49.084Z</lastUpdated>
  </row>
  <row>
    <udiDi>08717591240006</udiDi>
    <basicUdiDi>B-08717591240006</basicUdiDi>
    <tradeName>Macroplastique Implants, 1.5 cc syringe fill, 3.0 cc polycarbonate syringe</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Uroplasty, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000041660</manufacturerSrn>
    <authorisedRepresentativeName>Medical Measurement Systems B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000010438</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MPQ-1.5</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T00:53:38.501Z</lastUpdated>
  </row>
  <row>
    <udiDi>08717591240013</udiDi>
    <basicUdiDi>B-08717591240013</basicUdiDi>
    <tradeName>Macroplastique Implants, 2.5 cc syringe fill, 3.0 cc polycarbonate syringe</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Uroplasty, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000041660</manufacturerSrn>
    <authorisedRepresentativeName>Medical Measurement Systems B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000010438</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MPQ-2.5</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T00:53:38.483Z</lastUpdated>
  </row>
  <row>
    <udiDi>08717591240099</udiDi>
    <basicUdiDi>B-08717591240099</basicUdiDi>
    <tradeName>Adult Rigid Endoscopic Needle, 16 gauge, 15”</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Uroplasty, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000041660</manufacturerSrn>
    <authorisedRepresentativeName>Medical Measurement Systems B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000010438</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MRN-018</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T00:53:38.464Z</lastUpdated>
  </row>
  <row>
    <udiDi>08717591240105</udiDi>
    <basicUdiDi>B-08717591240105</basicUdiDi>
    <tradeName>Pediatric Rigid Endoscopic Needle, 18 gauge, 12”</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Uroplasty, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000041660</manufacturerSrn>
    <authorisedRepresentativeName>Medical Measurement Systems B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000010438</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MRN-020</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T00:53:38.445Z</lastUpdated>
  </row>
  <row>
    <udiDi>08717591240204</udiDi>
    <basicUdiDi>B-08717591240204</basicUdiDi>
    <tradeName>VOX Implants, 1.0 cc syringe fill, 3.0 cc polycarbonate syringe</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Uroplasty, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000041660</manufacturerSrn>
    <authorisedRepresentativeName>Medical Measurement Systems B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000010438</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VOX-1.0</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T00:53:38.431Z</lastUpdated>
  </row>
  <row>
    <udiDi>00627825000062</udiDi>
    <basicUdiDi>062782502NB</basicUdiDi>
    <tradeName>00627825000062</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Laborie Medical Technologies Corp.</manufacturerName>
    <manufacturerSrn>US-MF-000022925</manufacturerSrn>
    <authorisedRepresentativeName>Medical Measurement Systems B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000010438</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TUB101</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T14:06:18.768Z</lastUpdated>
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  <row>
    <udiDi>00627825000130</udiDi>
    <basicUdiDi>062782507NM</basicUdiDi>
    <tradeName>injeTAK Adjustable Tip Needle (35 cm)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Laborie Medical Technologies Corp.</manufacturerName>
    <manufacturerSrn>US-MF-000022925</manufacturerSrn>
    <authorisedRepresentativeName>Medical Measurement Systems B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000010438</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>NEEDLES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DIS199-E</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T14:06:18.747Z</lastUpdated>
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    <udiDi>00627825000147</udiDi>
    <basicUdiDi>062782507NM</basicUdiDi>
    <tradeName>injeTAK Adjustable Tip Needle (70 cm)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Laborie Medical Technologies Corp.</manufacturerName>
    <manufacturerSrn>US-MF-000022925</manufacturerSrn>
    <authorisedRepresentativeName>Medical Measurement Systems B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000010438</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>NEEDLES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DIS201-E</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T14:06:18.719Z</lastUpdated>
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    <udiDi>00627825001014</udiDi>
    <basicUdiDi>062782504NF</basicUdiDi>
    <tradeName>T-DOC Air-Charged Catheters</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Laborie Medical Technologies Corp.</manufacturerName>
    <manufacturerSrn>US-MF-000022925</manufacturerSrn>
    <authorisedRepresentativeName>Medical Measurement Systems B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000010438</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>URODYNAMICS INSTRUMENTS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CAT875</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T14:06:18.699Z</lastUpdated>
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    <udiDi>00627825001021</udiDi>
    <basicUdiDi>062782504NF</basicUdiDi>
    <tradeName>T-DOC Air-Charged Dual Sensor Catheter</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Laborie Medical Technologies Corp.</manufacturerName>
    <manufacturerSrn>US-MF-000022925</manufacturerSrn>
    <authorisedRepresentativeName>Medical Measurement Systems B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000010438</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>URODYNAMICS INSTRUMENTS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CAT880</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T14:06:18.676Z</lastUpdated>
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  <row>
    <udiDi>00627825001038</udiDi>
    <basicUdiDi>062782504NF</basicUdiDi>
    <tradeName>T-DOC Air-Charged Single Sensor Catheter</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Laborie Medical Technologies Corp.</manufacturerName>
    <manufacturerSrn>US-MF-000022925</manufacturerSrn>
    <authorisedRepresentativeName>Medical Measurement Systems B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000010438</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>URODYNAMICS INSTRUMENTS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CAT895</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T14:06:18.648Z</lastUpdated>
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