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    <tradeName>Guiding Sheath (GSQ)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Q3 Medical Germany GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000008095</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C0502</emdnCode>
    <emdnDescription>CARDIOVASCULAR INTRODUCER SHEATHS, VALVED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GSQ100A5</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T01:40:57.519Z</lastUpdated>
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    <udiDi>04051649234611</udiDi>
    <basicUdiDi>B-04051649234611</basicUdiDi>
    <tradeName>Guiding Sheath (GSQ)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Q3 Medical Germany GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000008095</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <legislation>MDD</legislation>
    <emdnCode>C0502</emdnCode>
    <emdnDescription>CARDIOVASCULAR INTRODUCER SHEATHS, VALVED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GSQ080A5</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T01:40:56.729Z</lastUpdated>
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    <udiDi>04051649234604</udiDi>
    <basicUdiDi>B-04051649234604</basicUdiDi>
    <tradeName>Guiding Sheath (GSQ)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Q3 Medical Germany GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000008095</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C0502</emdnCode>
    <emdnDescription>CARDIOVASCULAR INTRODUCER SHEATHS, VALVED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GSQ045A5</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T01:40:55.914Z</lastUpdated>
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    <udiDi>04051649234598</udiDi>
    <basicUdiDi>B-04051649234598</basicUdiDi>
    <tradeName>Guiding Sheath (GSQ)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Q3 Medical Germany GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000008095</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C0502</emdnCode>
    <emdnDescription>CARDIOVASCULAR INTRODUCER SHEATHS, VALVED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GSQ025A5</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T01:40:55.119Z</lastUpdated>
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    <udiDi>04051649234581</udiDi>
    <basicUdiDi>B-04051649234581</basicUdiDi>
    <tradeName>Guiding Sheath (GSQ)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Q3 Medical Germany GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000008095</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C0502</emdnCode>
    <emdnDescription>CARDIOVASCULAR INTRODUCER SHEATHS, VALVED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GSQ015A5</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T01:40:51.127Z</lastUpdated>
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    <udiDi>10801902207057</udiDi>
    <basicUdiDi>08019020000000000000103K3</basicUdiDi>
    <tradeName>Percutaneous Sheath Introducer for use with 7 - 8 Fr. Catheters</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Arrow International LLC (Subsidiary of Teleflex Incorporated)</manufacturerName>
    <manufacturerSrn>US-MF-000024256</manufacturerSrn>
    <authorisedRepresentativeName>Teleflex Medical</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000015869</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C0502</emdnCode>
    <emdnDescription>CARDIOVASCULAR INTRODUCER SHEATHS, VALVED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SS-09903-S</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:38:50.736Z</lastUpdated>
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    <udiDi>00884450526156</udiDi>
    <basicUdiDi>B-00884450526156</basicUdiDi>
    <tradeName>Prelude EASE™</tradeName>
    <deviceName>Prelude EASE™</deviceName>
    <manufacturerName>Merit Medical Systems, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000001366</manufacturerSrn>
    <authorisedRepresentativeName>Merit Medical Ireland Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000001011</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C0502</emdnCode>
    <emdnDescription>CARDIOVASCULAR INTRODUCER SHEATHS, VALVED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PHR6F11021SC/F</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:59:20.589Z</lastUpdated>
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    <udiDi>00884450415351</udiDi>
    <basicUdiDi>B-00884450415351</basicUdiDi>
    <tradeName>Prelude®</tradeName>
    <deviceName>Prelude®</deviceName>
    <manufacturerName>Merit Medical Systems, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000001366</manufacturerSrn>
    <authorisedRepresentativeName>Merit Medical Ireland Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000001011</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C0502</emdnCode>
    <emdnDescription>CARDIOVASCULAR INTRODUCER SHEATHS, VALVED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PSI-4F-23MT/J</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:59:12.700Z</lastUpdated>
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    <udiDi>00813502011685</udiDi>
    <basicUdiDi>B-00813502011685</basicUdiDi>
    <tradeName>00813502011685</tradeName>
    <deviceName>Impella CP Introducer Kit</deviceName>
    <manufacturerName>Abiomed Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000016855</manufacturerSrn>
    <authorisedRepresentativeName>Abiomed Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005280</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C0502</emdnCode>
    <emdnDescription>CARDIOVASCULAR INTRODUCER SHEATHS, VALVED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0052-3052/0052-0038, 0052-3053/0052-0039</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-04T17:48:31.554Z</lastUpdated>
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    <udiDi>00685447018568</udiDi>
    <basicUdiDi>B-00685447018568</basicUdiDi>
    <tradeName>SureFlex™</tradeName>
    <deviceName>SureFlex Steerable Guiding Sheath</deviceName>
    <manufacturerName>Baylis Medical Company Inc.</manufacturerName>
    <manufacturerSrn>CA-MF-000024361</manufacturerSrn>
    <authorisedRepresentativeName>Quality First International OÜ</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>EE-AR-000004308</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C0502</emdnCode>
    <emdnDescription>CARDIOVASCULAR INTRODUCER SHEATHS, VALVED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TSK3005</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T15:03:03.964Z</lastUpdated>
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    <udiDi>00685447018551</udiDi>
    <basicUdiDi>B-00685447018551</basicUdiDi>
    <tradeName>SureFlex™</tradeName>
    <deviceName>SureFlex Steerable Guiding Sheath</deviceName>
    <manufacturerName>Baylis Medical Company Inc.</manufacturerName>
    <manufacturerSrn>CA-MF-000024361</manufacturerSrn>
    <authorisedRepresentativeName>Quality First International OÜ</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>EE-AR-000004308</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C0502</emdnCode>
    <emdnDescription>CARDIOVASCULAR INTRODUCER SHEATHS, VALVED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TSK3003</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T15:02:59.877Z</lastUpdated>
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    <udiDi>00685447018544</udiDi>
    <basicUdiDi>B-00685447018544</basicUdiDi>
    <tradeName>SureFlex™</tradeName>
    <deviceName>SureFlex Steerable Guiding Sheath</deviceName>
    <manufacturerName>Baylis Medical Company Inc.</manufacturerName>
    <manufacturerSrn>CA-MF-000024361</manufacturerSrn>
    <authorisedRepresentativeName>Quality First International OÜ</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>EE-AR-000004308</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C0502</emdnCode>
    <emdnDescription>CARDIOVASCULAR INTRODUCER SHEATHS, VALVED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TSK3001</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T15:02:59.079Z</lastUpdated>
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    <udiDi>08906194162208</udiDi>
    <basicUdiDi>890619416NTISQ2</basicUdiDi>
    <tradeName>ClearSheath</tradeName>
    <deviceName>Introducer Sheath with Dilator</deviceName>
    <manufacturerName>Newtech Medical Devices Pvt. Ltd.</manufacturerName>
    <manufacturerSrn>IN-MF-000045809</manufacturerSrn>
    <authorisedRepresentativeName>Amstermed B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001971</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C0502</emdnCode>
    <emdnDescription>CARDIOVASCULAR INTRODUCER SHEATHS, VALVED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NT/IS/FSM/0407</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T18:53:45.122Z</lastUpdated>
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    <udiDi>08906141290077</udiDi>
    <basicUdiDi>890614129PISFKR</basicUdiDi>
    <tradeName>Introducer sheath kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Prymax Healthcare LLP</manufacturerName>
    <manufacturerSrn>IN-MF-000032225</manufacturerSrn>
    <authorisedRepresentativeName>Compliance Management Solutions Europe LTD</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BG-AR-000020809</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>C0502</emdnCode>
    <emdnDescription>CARDIOVASCULAR INTRODUCER SHEATHS, VALVED</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>PISF-8F18G35SS</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-03T18:45:08.745Z</lastUpdated>
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    <udiDi>08054242441505</udiDi>
    <basicUdiDi>803300326222000002MH</basicUdiDi>
    <tradeName>08054242441505</tradeName>
    <deviceName></deviceName>
    <manufacturerName>FIAB S.p.A.</manufacturerName>
    <manufacturerSrn>IT-MF-000005988</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C0502</emdnCode>
    <emdnDescription>CARDIOVASCULAR INTRODUCER SHEATHS, VALVED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>F47705V</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T05:05:18.154Z</lastUpdated>
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    <tradeName>06973245045492</tradeName>
    <deviceName>Introducer sheaths</deviceName>
    <manufacturerName>Brun Medical Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000009738</manufacturerSrn>
    <authorisedRepresentativeName>Cnovate Medical B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000039205</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C0502</emdnCode>
    <emdnDescription>CARDIOVASCULAR INTRODUCER SHEATHS, VALVED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BR-RA0507</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-02T11:26:53.136Z</lastUpdated>
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    <tradeName>Introducer Sheath Sets</tradeName>
    <deviceName>Introducer Sheath Sets</deviceName>
    <manufacturerName>BrosMed Medical</manufacturerName>
    <manufacturerSrn>CN-PR-000048143</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C0502</emdnCode>
    <emdnDescription>CARDIOVASCULAR INTRODUCER SHEATHS, VALVED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BM-FA0419L</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-02T08:00:51.872Z</lastUpdated>
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    <udiDi>06927741072520</udiDi>
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    <tradeName>Sterile Catheter Sheath Sets</tradeName>
    <deviceName>Sterile Catheter Sheath Sets</deviceName>
    <manufacturerName>Zhejiang Barty Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000007977</manufacturerSrn>
    <authorisedRepresentativeName>MedPath GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000087</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C0502</emdnCode>
    <emdnDescription>CARDIOVASCULAR INTRODUCER SHEATHS, VALVED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>QB040300A35WHZ0</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T06:45:03.241Z</lastUpdated>
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    <tradeName>Sterile Catheter Sheath Sets</tradeName>
    <deviceName>Sterile Catheter Sheath Sets</deviceName>
    <manufacturerName>Zhejiang Barty Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000007977</manufacturerSrn>
    <authorisedRepresentativeName>MedPath GmbH</authorisedRepresentativeName>
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    <emdnCode>C0502</emdnCode>
    <emdnDescription>CARDIOVASCULAR INTRODUCER SHEATHS, VALVED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>QA040050A18NOP1</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T06:45:02.445Z</lastUpdated>
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    <basicUdiDi>69277410ZBT0009052GJ</basicUdiDi>
    <tradeName>Sterile Catheter Sheath Sets</tradeName>
    <deviceName>Sterile Catheter Sheath Sets</deviceName>
    <manufacturerName>Zhejiang Barty Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000007977</manufacturerSrn>
    <authorisedRepresentativeName>MedPath GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000087</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C0502</emdnCode>
    <emdnDescription>CARDIOVASCULAR INTRODUCER SHEATHS, VALVED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>QA040070A18NHP0</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T06:45:01.637Z</lastUpdated>
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