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<eudamedExport entity="devices">
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    <udiDi>05060111783235</udiDi>
    <basicUdiDi>50601117812535171VK</basicUdiDi>
    <tradeName>Curing Light Gun Sleeve  - Unodent</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Astek Innovations Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000013346</manufacturerSrn>
    <authorisedRepresentativeName>Young Microbrush Ireland Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000011249</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>T030199</emdnCode>
    <emdnDescription>COVERS, INSTRUMENTS AND EQUIPMENT - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CVH130</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-18T13:17:19.399Z</lastUpdated>
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  <row>
    <udiDi>04260434710272</udiDi>
    <basicUdiDi>426043471EQPCoversPP-GFD</basicUdiDi>
    <tradeName>SonoGuard Set</tradeName>
    <deviceName>Procedure Pack - Equipment Cover and Gel</deviceName>
    <manufacturerName>PROMECON GmbH</manufacturerName>
    <manufacturerSrn>DE-PR-000035547</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>T030199</emdnCode>
    <emdnDescription>COVERS, INSTRUMENTS AND EQUIPMENT - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SG.10.140.120-G</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-17T19:44:38.962Z</lastUpdated>
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  <row>
    <udiDi>04260434710043</udiDi>
    <basicUdiDi>426043471EQPCovers4W</basicUdiDi>
    <tradeName>SonoGuard</tradeName>
    <deviceName>Equipment Cover</deviceName>
    <manufacturerName>PROMECON GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000015290</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>T030199</emdnCode>
    <emdnDescription>COVERS, INSTRUMENTS AND EQUIPMENT - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SG.10.140.160</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T19:44:38.164Z</lastUpdated>
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  <row>
    <udiDi>04260434710005</udiDi>
    <basicUdiDi>426043471EQPCovers4W</basicUdiDi>
    <tradeName>SonoGuard</tradeName>
    <deviceName></deviceName>
    <manufacturerName>PROMECON GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000015290</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>T030199</emdnCode>
    <emdnDescription>COVERS, INSTRUMENTS AND EQUIPMENT - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SG.10.140.025</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-17T19:39:11.668Z</lastUpdated>
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  <row>
    <udiDi>04260434710029</udiDi>
    <basicUdiDi>426043471EQPCovers4W</basicUdiDi>
    <tradeName>SonoGuard</tradeName>
    <deviceName></deviceName>
    <manufacturerName>PROMECON GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000015290</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>T030199</emdnCode>
    <emdnDescription>COVERS, INSTRUMENTS AND EQUIPMENT - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SG.10.140.080</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-17T19:39:01.093Z</lastUpdated>
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  <row>
    <udiDi>04260434710081</udiDi>
    <basicUdiDi>426043471EQPCovers4W</basicUdiDi>
    <tradeName>SonoGuard Plus</tradeName>
    <deviceName></deviceName>
    <manufacturerName>PROMECON GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000015290</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>T030199</emdnCode>
    <emdnDescription>COVERS, INSTRUMENTS AND EQUIPMENT - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SG.20.180.040</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-17T19:38:47.762Z</lastUpdated>
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  <row>
    <udiDi>04260434710036</udiDi>
    <basicUdiDi>426043471EQPCovers4W</basicUdiDi>
    <tradeName>SonoGuard</tradeName>
    <deviceName></deviceName>
    <manufacturerName>PROMECON GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000015290</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>T030199</emdnCode>
    <emdnDescription>COVERS, INSTRUMENTS AND EQUIPMENT - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SG.10.140.120</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-17T19:38:43.505Z</lastUpdated>
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  <row>
    <udiDi>D-70340SHEATHESFY</udiDi>
    <basicUdiDi>B-70340SHEATHESFY</basicUdiDi>
    <tradeName>D-70340SHEATHESFY</tradeName>
    <deviceName>Sterile, Ultrasound Probe Cover with 1 Elastic, Vaginal/Rectal, Seamless, Straight, Rolled, Extra-Long</deviceName>
    <manufacturerName>Sheathing Technologies, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000044559</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>T030199</emdnCode>
    <emdnDescription>COVERS, INSTRUMENTS AND EQUIPMENT - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>70340</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:29:14.811Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-70340(ITL)SHEATHESAW</udiDi>
    <basicUdiDi>B-70340(ITL)SHEATHESAW</basicUdiDi>
    <tradeName>D-70340(ITL)SHEATHESAW</tradeName>
    <deviceName>Sterile, Ultrasound Probe Cover with 1 Elastic, Vaginal/Rectal, Seamless, Straight, Rolled, Extra-Long</deviceName>
    <manufacturerName>Sheathing Technologies, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000044559</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>T030199</emdnCode>
    <emdnDescription>COVERS, INSTRUMENTS AND EQUIPMENT - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>70340 (ITL)</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:29:09.770Z</lastUpdated>
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  <row>
    <udiDi>D-50040366SHEATHESLT</udiDi>
    <basicUdiDi>B-50040366SHEATHESLT</basicUdiDi>
    <tradeName>D-50040366SHEATHESLT</tradeName>
    <deviceName>Sterile, Extended Field Ultrasound Probe &amp; Cord Cover with 2 Elastics, Rolled</deviceName>
    <manufacturerName>Sheathing Technologies, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000044559</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>T030199</emdnCode>
    <emdnDescription>COVERS, INSTRUMENTS AND EQUIPMENT - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>50040-366</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T23:15:57.373Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-50040-IH486SHEATHESUX</udiDi>
    <basicUdiDi>B-50040-IH486SHEATHESUX</basicUdiDi>
    <tradeName>D-50040-IH486SHEATHESUX</tradeName>
    <deviceName>Sterile, Extended Field Ultrasound Probe &amp; Cord Cover with 2 Elastics, Rolled</deviceName>
    <manufacturerName>Sheathing Technologies, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000044559</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>T030199</emdnCode>
    <emdnDescription>COVERS, INSTRUMENTS AND EQUIPMENT - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>50040-IH486</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T23:15:56.158Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-50040-366(ITL)EG</udiDi>
    <basicUdiDi>B-50040-366(ITL)EG</basicUdiDi>
    <tradeName>D-50040-366(ITL)EG</tradeName>
    <deviceName>Sterile, Extended Field Ultrasound Probe &amp; Cord Cover with 2 Elastics, Rolled</deviceName>
    <manufacturerName>Sheathing Technologies, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000044559</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>T030199</emdnCode>
    <emdnDescription>COVERS, INSTRUMENTS AND EQUIPMENT - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>50040-366 (ITL)</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-16T23:15:55.518Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-50040-363SHEATHES8F</udiDi>
    <basicUdiDi>B-50040-363SHEATHES8F</basicUdiDi>
    <tradeName>D-50040-363SHEATHES8F</tradeName>
    <deviceName>Sterile, Extended Field Ultrasound Probe &amp; Cord Cover with 2 Elastics, Rolled</deviceName>
    <manufacturerName>Sheathing Technologies, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000044559</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>T030199</emdnCode>
    <emdnDescription>COVERS, INSTRUMENTS AND EQUIPMENT - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>50040-363</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T23:15:54.300Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-50040-304SHEATHES3Q</udiDi>
    <basicUdiDi>B-50040-304SHEATHES3Q</basicUdiDi>
    <tradeName>D-50040-304SHEATHES3Q</tradeName>
    <deviceName>Sterile, Extended Field Ultrasound Probe &amp; Cord Cover with 2 Elastics, Rolled</deviceName>
    <manufacturerName>Sheathing Technologies, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000044559</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>T030199</emdnCode>
    <emdnDescription>COVERS, INSTRUMENTS AND EQUIPMENT - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>50040-304</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T23:15:51.158Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-50040-304(ITL)AG</udiDi>
    <basicUdiDi>B-50040-304(ITL)AG</basicUdiDi>
    <tradeName>D-50040-304(ITL)AG</tradeName>
    <deviceName>Sterile, Extended Field Ultrasound Probe &amp; Cord Cover with 2 Elastics, Rolled</deviceName>
    <manufacturerName>Sheathing Technologies, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000044559</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>T030199</emdnCode>
    <emdnDescription>COVERS, INSTRUMENTS AND EQUIPMENT - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>50040-304 (ITL)</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-16T23:15:49.529Z</lastUpdated>
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  <row>
    <udiDi>D-50040-245SHEATHES74</udiDi>
    <basicUdiDi>B-50040-245SHEATHES74</basicUdiDi>
    <tradeName>D-50040-245SHEATHES74</tradeName>
    <deviceName>Sterile, Extended Field Ultrasound Probe &amp; Cord Cover with 2 Elastics, Rolled</deviceName>
    <manufacturerName>Sheathing Technologies, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000044559</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>T030199</emdnCode>
    <emdnDescription>COVERS, INSTRUMENTS AND EQUIPMENT - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>50040-245</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T23:15:49.473Z</lastUpdated>
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  <row>
    <udiDi>D-50040-241CTSHEATHES5S</udiDi>
    <basicUdiDi>B-50040-241CTSHEATHES5S</basicUdiDi>
    <tradeName>D-50040-241CTSHEATHES5S</tradeName>
    <deviceName>Sterile, Extended Field Ultrasound Probe &amp; Cord Cover with 2 Elastics, Intraoperative, Custom Tip, Rolled</deviceName>
    <manufacturerName>Sheathing Technologies, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000044559</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>T030199</emdnCode>
    <emdnDescription>COVERS, INSTRUMENTS AND EQUIPMENT - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>50040-241CT</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T23:15:47.090Z</lastUpdated>
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  <row>
    <udiDi>04034342356088</udiDi>
    <basicUdiDi>B-04034342356088</basicUdiDi>
    <tradeName>04034342356088</tradeName>
    <deviceName>Sterile cover for surgical light handle</deviceName>
    <manufacturerName>P. J. Dahlhausen &amp; Co. GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000006357</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>T030199</emdnCode>
    <emdnDescription>COVERS, INSTRUMENTS AND EQUIPMENT - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>42.700.01.002</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T11:51:00.321Z</lastUpdated>
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    <udiDi>04034342321024</udiDi>
    <basicUdiDi>B-04034342321024</basicUdiDi>
    <tradeName>04034342321024</tradeName>
    <deviceName>Sterile cover for surgical light handle</deviceName>
    <manufacturerName>P. J. Dahlhausen &amp; Co. GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000006357</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>T030199</emdnCode>
    <emdnDescription>COVERS, INSTRUMENTS AND EQUIPMENT - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>42.700.01.001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T11:48:46.662Z</lastUpdated>
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    <udiDi>08057500512191</udiDi>
    <basicUdiDi>805750051T030199RG</basicUdiDi>
    <tradeName>COPRIPEDALIERA CON LACCI</tradeName>
    <deviceName>COPERTURE VARIE non sterili</deviceName>
    <manufacturerName>GIFRAMED S.r.l.</manufacturerName>
    <manufacturerSrn>IT-MF-000021952</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>T030199</emdnCode>
    <emdnDescription>COVERS, INSTRUMENTS AND EQUIPMENT - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CPL050/NS</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-16T09:08:31.448Z</lastUpdated>
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