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    <tradeName>Disposable Endoscopy Dilation Balloon</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Alton (Shanghai) Medical Instruments Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012832</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>G03010199</emdnCode>
    <emdnDescription>GASTROINTESTINAL ENDOSCOPY, BALLOON CATHETERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AF-D0718BC1880F</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-07T03:45:52.235Z</lastUpdated>
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    <udiDi>06942127888793</udiDi>
    <basicUdiDi>697067138BC044AN</basicUdiDi>
    <tradeName>Disposable Endoscopy Dilation Balloon</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Alton (Shanghai) Medical Instruments Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012832</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>G03010199</emdnCode>
    <emdnDescription>GASTROINTESTINAL ENDOSCOPY, BALLOON CATHETERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AF-D0718BC2060F</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-07T03:45:52.120Z</lastUpdated>
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    <udiDi>06942127888809</udiDi>
    <basicUdiDi>697067138BC044AN</basicUdiDi>
    <tradeName>Disposable Endoscopy Dilation Balloon</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Alton (Shanghai) Medical Instruments Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012832</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>G03010199</emdnCode>
    <emdnDescription>GASTROINTESTINAL ENDOSCOPY, BALLOON CATHETERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AF-D0718BC2080F</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-07T03:45:51.555Z</lastUpdated>
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    <udiDi>06942127888816</udiDi>
    <basicUdiDi>697067138BC044AN</basicUdiDi>
    <tradeName>Disposable Endoscopy Dilation Balloon</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Alton (Shanghai) Medical Instruments Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012832</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>G03010199</emdnCode>
    <emdnDescription>GASTROINTESTINAL ENDOSCOPY, BALLOON CATHETERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AF-D0720BC0660F</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-07T03:45:51.295Z</lastUpdated>
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    <udiDi>00827002517998</udiDi>
    <basicUdiDi>B-00827002517998</basicUdiDi>
    <tradeName>00827002517998</tradeName>
    <deviceName>Hercules 3 Stage WireGuided Balloon Esophageal-Pyloric Colonic</deviceName>
    <manufacturerName>Wilson-Cook Medical, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000002658</manufacturerSrn>
    <authorisedRepresentativeName>COOK MEDICAL EUROPE LIMITED</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000907</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>G03010199</emdnCode>
    <emdnDescription>GASTROINTESTINAL ENDOSCOPY, BALLOON CATHETERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HBD-W-8-9-10</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-04T19:50:43.779Z</lastUpdated>
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    <udiDi>00827002517974</udiDi>
    <basicUdiDi>B-00827002517974</basicUdiDi>
    <tradeName>00827002517974</tradeName>
    <deviceName>Hercules 3 Stage WireGuided Balloon Esophageal-Pyloric Colonic</deviceName>
    <manufacturerName>Wilson-Cook Medical, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000002658</manufacturerSrn>
    <authorisedRepresentativeName>COOK MEDICAL EUROPE LIMITED</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000907</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>G03010199</emdnCode>
    <emdnDescription>GASTROINTESTINAL ENDOSCOPY, BALLOON CATHETERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HBD-W-15-16.5-18</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-04T19:50:41.374Z</lastUpdated>
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    <udiDi>00827002517981</udiDi>
    <basicUdiDi>B-00827002517981</basicUdiDi>
    <tradeName>00827002517981</tradeName>
    <deviceName>Hercules 3 Stage WireGuided Balloon Esophageal-Pyloric Colonic</deviceName>
    <manufacturerName>Wilson-Cook Medical, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000002658</manufacturerSrn>
    <authorisedRepresentativeName>COOK MEDICAL EUROPE LIMITED</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000907</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>G03010199</emdnCode>
    <emdnDescription>GASTROINTESTINAL ENDOSCOPY, BALLOON CATHETERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HBD-W-18-19-20</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-04T19:50:39.770Z</lastUpdated>
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    <udiDi>00827002517950</udiDi>
    <basicUdiDi>B-00827002517950</basicUdiDi>
    <tradeName>00827002517950</tradeName>
    <deviceName>Hercules 3 Stage WireGuided Balloon Esophageal-Pyloric Colonic</deviceName>
    <manufacturerName>Wilson-Cook Medical, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000002658</manufacturerSrn>
    <authorisedRepresentativeName>COOK MEDICAL EUROPE LIMITED</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000907</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>G03010199</emdnCode>
    <emdnDescription>GASTROINTESTINAL ENDOSCOPY, BALLOON CATHETERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HBD-W-10-11-12</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-04T19:50:38.970Z</lastUpdated>
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  <row>
    <udiDi>00827002517967</udiDi>
    <basicUdiDi>B-00827002517967</basicUdiDi>
    <tradeName>00827002517967</tradeName>
    <deviceName>Hercules 3 Stage WireGuided Balloon Esophageal-Pyloric Colonic</deviceName>
    <manufacturerName>Wilson-Cook Medical, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000002658</manufacturerSrn>
    <authorisedRepresentativeName>COOK MEDICAL EUROPE LIMITED</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000907</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>G03010199</emdnCode>
    <emdnDescription>GASTROINTESTINAL ENDOSCOPY, BALLOON CATHETERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HBD-W-12-13.5-15</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-04T19:50:36.566Z</lastUpdated>
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  <row>
    <udiDi>00827002487321</udiDi>
    <basicUdiDi>B-00827002487321</basicUdiDi>
    <tradeName>00827002487321</tradeName>
    <deviceName>HERCULES 3 STAGE BALLOON ESOPHAGEAL</deviceName>
    <manufacturerName>Wilson-Cook Medical, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000002658</manufacturerSrn>
    <authorisedRepresentativeName>COOK MEDICAL EUROPE LIMITED</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000907</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>G03010199</emdnCode>
    <emdnDescription>GASTROINTESTINAL ENDOSCOPY, BALLOON CATHETERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HBD-15-16.5-18</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-04T19:45:16.061Z</lastUpdated>
  </row>
  <row>
    <udiDi>00827002319288</udiDi>
    <basicUdiDi>B-00827002319288</basicUdiDi>
    <tradeName>00827002319288</tradeName>
    <deviceName>HERCULES 3 STAGE BALLOON ESOPHAGEAL</deviceName>
    <manufacturerName>Wilson-Cook Medical, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000002658</manufacturerSrn>
    <authorisedRepresentativeName>COOK MEDICAL EUROPE LIMITED</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000907</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>G03010199</emdnCode>
    <emdnDescription>GASTROINTESTINAL ENDOSCOPY, BALLOON CATHETERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HBD-8-9-10</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-04T19:39:45.163Z</lastUpdated>
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  <row>
    <udiDi>00827002319257</udiDi>
    <basicUdiDi>B-00827002319257</basicUdiDi>
    <tradeName>00827002319257</tradeName>
    <deviceName>HERCULES 3 STAGE BALLOON ESOPHAGEAL</deviceName>
    <manufacturerName>Wilson-Cook Medical, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000002658</manufacturerSrn>
    <authorisedRepresentativeName>COOK MEDICAL EUROPE LIMITED</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000907</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>G03010199</emdnCode>
    <emdnDescription>GASTROINTESTINAL ENDOSCOPY, BALLOON CATHETERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HBD-10-11-12</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-04T19:39:42.755Z</lastUpdated>
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  <row>
    <udiDi>00827002319271</udiDi>
    <basicUdiDi>B-00827002319271</basicUdiDi>
    <tradeName>00827002319271</tradeName>
    <deviceName>HERCULES 3 STAGE BALLOON ESOPHAGEAL</deviceName>
    <manufacturerName>Wilson-Cook Medical, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000002658</manufacturerSrn>
    <authorisedRepresentativeName>COOK MEDICAL EUROPE LIMITED</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000907</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>G03010199</emdnCode>
    <emdnDescription>GASTROINTESTINAL ENDOSCOPY, BALLOON CATHETERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HBD-18-19-20</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-04T19:39:40.357Z</lastUpdated>
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    <udiDi>00827002319264</udiDi>
    <basicUdiDi>B-00827002319264</basicUdiDi>
    <tradeName>00827002319264</tradeName>
    <deviceName>HERCULES 3 STAGE BALLOON ESOPHAGEAL</deviceName>
    <manufacturerName>Wilson-Cook Medical, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000002658</manufacturerSrn>
    <authorisedRepresentativeName>COOK MEDICAL EUROPE LIMITED</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000907</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>G03010199</emdnCode>
    <emdnDescription>GASTROINTESTINAL ENDOSCOPY, BALLOON CATHETERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HBD-12-13.5-15</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-04T19:39:39.556Z</lastUpdated>
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    <udiDi>07290018334805</udiDi>
    <basicUdiDi>7290018334BAR5A</basicUdiDi>
    <tradeName>07290018334805</tradeName>
    <deviceName>Barostat Test Pack</deviceName>
    <manufacturerName>Colospan LTD</manufacturerName>
    <manufacturerSrn>IL-PR-000052725</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>G03010199</emdnCode>
    <emdnDescription>GASTROINTESTINAL ENDOSCOPY, BALLOON CATHETERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BTP001</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-02T22:22:47.104Z</lastUpdated>
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    <udiDi>06975597851370</udiDi>
    <basicUdiDi>697559785PE09UL</basicUdiDi>
    <tradeName>06975597851370</tradeName>
    <deviceName>Disposable Dilation Balloon Catheters</deviceName>
    <manufacturerName>Jiangsu Power-endo Medical Technology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000030213</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>G03010199</emdnCode>
    <emdnDescription>GASTROINTESTINAL ENDOSCOPY, BALLOON CATHETERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ENDO-DB1-07-0640-250</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-02T16:19:46.784Z</lastUpdated>
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    <udiDi>06936534345826</udiDi>
    <basicUdiDi>697417302MDBcatheterWT</basicUdiDi>
    <tradeName>Single Use Balloon Dilatation Catheters</tradeName>
    <deviceName>Single Use Balloon Dilatation Catheters</deviceName>
    <manufacturerName>Zhejiang Chuangxiang Medical Technology Co., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000012417</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>G03010199</emdnCode>
    <emdnDescription>GASTROINTESTINAL ENDOSCOPY, BALLOON CATHETERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MD-C-DB-2309-0420</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-02T12:34:33.848Z</lastUpdated>
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    <udiDi>06936534343037</udiDi>
    <basicUdiDi>697417302DBcatheterZE</basicUdiDi>
    <tradeName>Single Use Balloon Dilatation Catheters</tradeName>
    <deviceName>Single Use Balloon Dilatation Catheters</deviceName>
    <manufacturerName>Zhejiang Chuangxiang Medical Technology Co., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000012417</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>G03010199</emdnCode>
    <emdnDescription>GASTROINTESTINAL ENDOSCOPY, BALLOON CATHETERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MD-A-DB-2309-0420</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-02T12:34:33.071Z</lastUpdated>
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    <udiDi>06941513221831</udiDi>
    <basicUdiDi>697005757079JB</basicUdiDi>
    <tradeName>Gastrointestinal and Biliary Balloon Catheters</tradeName>
    <deviceName>Gastrointestinal and Biliary Balloon Catheters</deviceName>
    <manufacturerName>Jiangsu Vedkang Medical Science and Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008462</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>G03010199</emdnCode>
    <emdnDescription>GASTROINTESTINAL ENDOSCOPY, BALLOON CATHETERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VDK-RBD-06-30-180</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-02T08:02:03.983Z</lastUpdated>
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    <udiDi>06941513221602</udiDi>
    <basicUdiDi>697005757080HU</basicUdiDi>
    <tradeName>Gastrointestinal and Biliary Balloon Catheters</tradeName>
    <deviceName>Gastrointestinal and Biliary Balloon Catheters</deviceName>
    <manufacturerName>Jiangsu Vedkang Medical Science and Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008462</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>G03010199</emdnCode>
    <emdnDescription>GASTROINTESTINAL ENDOSCOPY, BALLOON CATHETERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VDK-RBD-6/7/8-40-200</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-02T08:02:03.186Z</lastUpdated>
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