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    <manufacturerName>GBUK Group</manufacturerName>
    <manufacturerSrn>GB-MF-000002238</manufacturerSrn>
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    <authorisedRepresentativeSrn>NL-AR-000000537</authorisedRepresentativeSrn>
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    <lastUpdated>2026-06-17T00:24:07.370Z</lastUpdated>
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    <udiDi>05056821811283</udiDi>
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    <deviceName></deviceName>
    <manufacturerName>GBUK Group</manufacturerName>
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    <lastUpdated>2026-06-17T00:24:04.372Z</lastUpdated>
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    <udiDi>05056821810996</udiDi>
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    <manufacturerName>GBUK Group</manufacturerName>
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    <authorisedRepresentativeName>Qualrep Services B.V.</authorisedRepresentativeName>
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    <emdnDescription>NON-RIGID SUPPORTS FOR LIFTS (HARNESSES)</emdnDescription>
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    <lastUpdated>2026-06-17T00:24:00.633Z</lastUpdated>
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    <udiDi>05056821811009</udiDi>
    <basicUdiDi>50568218HoistSlingsHB</basicUdiDi>
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    <deviceName></deviceName>
    <manufacturerName>GBUK Group</manufacturerName>
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    <authorisedRepresentativeSrn>NL-AR-000000537</authorisedRepresentativeSrn>
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    <emdnCode>V0805038002</emdnCode>
    <emdnDescription>NON-RIGID SUPPORTS FOR LIFTS (HARNESSES)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CC-CVHP-8</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-17T00:20:49.869Z</lastUpdated>
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    <udiDi>05060590880883</udiDi>
    <basicUdiDi>506059088EntDrainBagNS9M</basicUdiDi>
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    <deviceName></deviceName>
    <manufacturerName>GBUK Group</manufacturerName>
    <manufacturerSrn>GB-MF-000002238</manufacturerSrn>
    <authorisedRepresentativeName>Qualrep Services B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000537</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>A060301</emdnCode>
    <emdnDescription>COLLECTION BAGS AND OTHER CONTAINERS FOR DRAINAGES AND FISTULAS, SINGLE USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DBP-1500</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T19:08:35.960Z</lastUpdated>
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    <udiDi>07640328070021</udiDi>
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    <tradeName>POLTX_Fiber</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Polaroid Therapeutics AG</manufacturerName>
    <manufacturerSrn>CH-MF-000049447</manufacturerSrn>
    <authorisedRepresentativeName>Qualrep Services B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000537</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>M040404</emdnCode>
    <emdnDescription>CELLULOSE AND/OR MODIFIED CELLULOSE DRESSINGS, NON-COMBINED OR COMBINED WITH OTHER SUBSTANCES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>205101010</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T05:49:23.250Z</lastUpdated>
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    <udiDi>07640328070038</udiDi>
    <basicUdiDi>764032807FIBER_20S6</basicUdiDi>
    <tradeName>POLTX_Fiber</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Polaroid Therapeutics AG</manufacturerName>
    <manufacturerSrn>CH-MF-000049447</manufacturerSrn>
    <authorisedRepresentativeName>Qualrep Services B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000537</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>M040404</emdnCode>
    <emdnDescription>CELLULOSE AND/OR MODIFIED CELLULOSE DRESSINGS, NON-COMBINED OR COMBINED WITH OTHER SUBSTANCES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>205131010</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T05:49:23.233Z</lastUpdated>
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    <udiDi>07640328070045</udiDi>
    <basicUdiDi>764032807FIBER_20S6</basicUdiDi>
    <tradeName>POLTX_Fiber</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Polaroid Therapeutics AG</manufacturerName>
    <manufacturerSrn>CH-MF-000049447</manufacturerSrn>
    <authorisedRepresentativeName>Qualrep Services B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000537</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>M040404</emdnCode>
    <emdnDescription>CELLULOSE AND/OR MODIFIED CELLULOSE DRESSINGS, NON-COMBINED OR COMBINED WITH OTHER SUBSTANCES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>205151510</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T05:49:23.213Z</lastUpdated>
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    <udiDi>07640328070052</udiDi>
    <basicUdiDi>764032807FIBER_20S6</basicUdiDi>
    <tradeName>POLTX_Fiber</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Polaroid Therapeutics AG</manufacturerName>
    <manufacturerSrn>CH-MF-000049447</manufacturerSrn>
    <authorisedRepresentativeName>Qualrep Services B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000537</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>M040404</emdnCode>
    <emdnDescription>CELLULOSE AND/OR MODIFIED CELLULOSE DRESSINGS, NON-COMBINED OR COMBINED WITH OTHER SUBSTANCES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>205152005</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T05:49:23.193Z</lastUpdated>
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  <row>
    <udiDi>07640328070076</udiDi>
    <basicUdiDi>764032807FIBER_20S6</basicUdiDi>
    <tradeName>POLTX_Fiber</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Polaroid Therapeutics AG</manufacturerName>
    <manufacturerSrn>CH-MF-000049447</manufacturerSrn>
    <authorisedRepresentativeName>Qualrep Services B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000537</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>M040404</emdnCode>
    <emdnDescription>CELLULOSE AND/OR MODIFIED CELLULOSE DRESSINGS, NON-COMBINED OR COMBINED WITH OTHER SUBSTANCES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>206041005</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T05:49:23.173Z</lastUpdated>
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  <row>
    <udiDi>07640328070083</udiDi>
    <basicUdiDi>764032807FIBER_20S6</basicUdiDi>
    <tradeName>POLTX_Fiber</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Polaroid Therapeutics AG</manufacturerName>
    <manufacturerSrn>CH-MF-000049447</manufacturerSrn>
    <authorisedRepresentativeName>Qualrep Services B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000537</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>M040404</emdnCode>
    <emdnDescription>CELLULOSE AND/OR MODIFIED CELLULOSE DRESSINGS, NON-COMBINED OR COMBINED WITH OTHER SUBSTANCES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>206042005</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T05:49:23.153Z</lastUpdated>
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  <row>
    <udiDi>07640328070090</udiDi>
    <basicUdiDi>764032807FIBER_20S6</basicUdiDi>
    <tradeName>POLTX_Fiber</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Polaroid Therapeutics AG</manufacturerName>
    <manufacturerSrn>CH-MF-000049447</manufacturerSrn>
    <authorisedRepresentativeName>Qualrep Services B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000537</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>M040404</emdnCode>
    <emdnDescription>CELLULOSE AND/OR MODIFIED CELLULOSE DRESSINGS, NON-COMBINED OR COMBINED WITH OTHER SUBSTANCES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>206043005</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T05:49:23.138Z</lastUpdated>
  </row>
  <row>
    <udiDi>07640328070106</udiDi>
    <basicUdiDi>764032807FIBER_20S6</basicUdiDi>
    <tradeName>POLTX_Fiber</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Polaroid Therapeutics AG</manufacturerName>
    <manufacturerSrn>CH-MF-000049447</manufacturerSrn>
    <authorisedRepresentativeName>Qualrep Services B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000537</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>M040404</emdnCode>
    <emdnDescription>CELLULOSE AND/OR MODIFIED CELLULOSE DRESSINGS, NON-COMBINED OR COMBINED WITH OTHER SUBSTANCES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>206023005</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T05:49:23.122Z</lastUpdated>
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  <row>
    <udiDi>07640328070113</udiDi>
    <basicUdiDi>764032807FIBER_20S6</basicUdiDi>
    <tradeName>POLTX_Fiber</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Polaroid Therapeutics AG</manufacturerName>
    <manufacturerSrn>CH-MF-000049447</manufacturerSrn>
    <authorisedRepresentativeName>Qualrep Services B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000537</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>M040404</emdnCode>
    <emdnDescription>CELLULOSE AND/OR MODIFIED CELLULOSE DRESSINGS, NON-COMBINED OR COMBINED WITH OTHER SUBSTANCES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>206024505</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T05:49:23.106Z</lastUpdated>
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  <row>
    <udiDi>D-109-0004-001S7</udiDi>
    <basicUdiDi>B-109-0004-001S7</basicUdiDi>
    <tradeName>Esophageal Warming Balloon Catheter</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Adagio Medical, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000001129</manufacturerSrn>
    <authorisedRepresentativeName>Qualrep Services B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000537</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>109-0004-001</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:46:26.793Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-109-0013-001S9</udiDi>
    <basicUdiDi>B-109-0013-001S9</basicUdiDi>
    <tradeName>iCLAS™ Cryoablation Catheter</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Adagio Medical, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000001129</manufacturerSrn>
    <authorisedRepresentativeName>Qualrep Services B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000537</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>109-0013-001</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:46:26.771Z</lastUpdated>
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    <udiDi>D-109-0014-001SL</udiDi>
    <basicUdiDi>B-109-0014-001SL</basicUdiDi>
    <tradeName>iCLAS™ Shaped Stylet Accesory</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Adagio Medical, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000001129</manufacturerSrn>
    <authorisedRepresentativeName>Qualrep Services B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000537</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>109-0014-001</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:46:26.749Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-109-0014-002SN</udiDi>
    <basicUdiDi>B-109-0014-002SN</basicUdiDi>
    <tradeName>iCLAS™ Shaped Stylet Accesory</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Adagio Medical, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000001129</manufacturerSrn>
    <authorisedRepresentativeName>Qualrep Services B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000537</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>109-0014-002</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:46:26.730Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-109-0014-003SQ</udiDi>
    <basicUdiDi>B-109-0014-003SQ</basicUdiDi>
    <tradeName>iCLAS™ Shaped Stylet Accesory</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Adagio Medical, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000001129</manufacturerSrn>
    <authorisedRepresentativeName>Qualrep Services B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000537</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>109-0014-003</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:46:26.713Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-109-0014-004SS</udiDi>
    <basicUdiDi>B-109-0014-004SS</basicUdiDi>
    <tradeName>iCLAS™ Shaped Stylet Accesory</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Adagio Medical, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000001129</manufacturerSrn>
    <authorisedRepresentativeName>Qualrep Services B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000537</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>109-0014-004</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:46:26.694Z</lastUpdated>
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