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    <basicUdiDi>495317000130B5</basicUdiDi>
    <tradeName>URETERO-RENO FIBERSCOPE OLYMPUS URF-P7</tradeName>
    <deviceName></deviceName>
    <manufacturerName>OLYMPUS MEDICAL SYSTEMS CORP.</manufacturerName>
    <manufacturerSrn>JP-MF-000008016</manufacturerSrn>
    <authorisedRepresentativeName>Olympus Europa SE &amp; Co. KG</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006774</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>N5781852</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-08T03:45:15.831Z</lastUpdated>
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    <udiDi>04953170401213</udiDi>
    <basicUdiDi>495317000065BK</basicUdiDi>
    <tradeName>3D ADJUSTMENT CAP MAJ-2266</tradeName>
    <deviceName></deviceName>
    <manufacturerName>OLYMPUS MEDICAL SYSTEMS CORP.</manufacturerName>
    <manufacturerSrn>JP-MF-000008016</manufacturerSrn>
    <authorisedRepresentativeName>Olympus Europa SE &amp; Co. KG</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006774</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>N5781530</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-08T03:45:15.576Z</lastUpdated>
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    <udiDi>04953170425547</udiDi>
    <basicUdiDi>495317000044BB</basicUdiDi>
    <tradeName>RIGHT/LEFT ANGURATION KNOB ATTACHMENT MAJ-1072</tradeName>
    <deviceName></deviceName>
    <manufacturerName>OLYMPUS MEDICAL SYSTEMS CORP.</manufacturerName>
    <manufacturerSrn>JP-MF-000008016</manufacturerSrn>
    <authorisedRepresentativeName>Olympus Europa SE &amp; Co. KG</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006774</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>N6149450</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-08T03:45:15.562Z</lastUpdated>
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    <udiDi>04953170465925</udiDi>
    <basicUdiDi>495317000130B5</basicUdiDi>
    <tradeName>URETERO-RENO FIBERSCOPE OLYMPUS URF-P7R</tradeName>
    <deviceName></deviceName>
    <manufacturerName>OLYMPUS MEDICAL SYSTEMS CORP.</manufacturerName>
    <manufacturerSrn>JP-MF-000008016</manufacturerSrn>
    <authorisedRepresentativeName>Olympus Europa SE &amp; Co. KG</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006774</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>N5781952</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-08T03:45:14.711Z</lastUpdated>
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    <udiDi>00896506002071</udiDi>
    <basicUdiDi>B-00896506002071</basicUdiDi>
    <tradeName>Spiration Valve System</tradeName>
    <deviceName>Deployment Catheter and Loader</deviceName>
    <manufacturerName>Gyrus ACMI, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000034236</manufacturerSrn>
    <authorisedRepresentativeName>Olympus Europa SE &amp; Co. KG</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006774</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R9005</emdnCode>
    <emdnDescription>ENDOBRONCHIAL VALVES AND RELEASE SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IBV-C26N</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T13:03:13.454Z</lastUpdated>
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  <row>
    <udiDi>00896506002064</udiDi>
    <basicUdiDi>B-00896506002064</basicUdiDi>
    <tradeName>Spiration Valve System</tradeName>
    <deviceName>Valve in Cartridge</deviceName>
    <manufacturerName>Gyrus ACMI, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000034236</manufacturerSrn>
    <authorisedRepresentativeName>Olympus Europa SE &amp; Co. KG</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006774</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R9005</emdnCode>
    <emdnDescription>ENDOBRONCHIAL VALVES AND RELEASE SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IBV-V9</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T13:03:12.663Z</lastUpdated>
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  <row>
    <udiDi>00896506002057</udiDi>
    <basicUdiDi>B-00896506002057</basicUdiDi>
    <tradeName>Spiration Valve System</tradeName>
    <deviceName>Deployment Catheter and Loader</deviceName>
    <manufacturerName>Gyrus ACMI, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000034236</manufacturerSrn>
    <authorisedRepresentativeName>Olympus Europa SE &amp; Co. KG</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006774</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R9005</emdnCode>
    <emdnDescription>ENDOBRONCHIAL VALVES AND RELEASE SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IBV-C20</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T13:03:11.861Z</lastUpdated>
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    <udiDi>00896506002040</udiDi>
    <basicUdiDi>B-00896506002040</basicUdiDi>
    <tradeName>Spiration Valve System</tradeName>
    <deviceName>Airway Sizing Kit</deviceName>
    <manufacturerName>Gyrus ACMI, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000034236</manufacturerSrn>
    <authorisedRepresentativeName>Olympus Europa SE &amp; Co. KG</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006774</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>V9099</emdnCode>
    <emdnDescription>VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IBV-VSK</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T13:03:11.056Z</lastUpdated>
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  <row>
    <udiDi>00896506002026</udiDi>
    <basicUdiDi>B-00896506002026</basicUdiDi>
    <tradeName>Spiration Valve System</tradeName>
    <deviceName>Valve in Cartridge</deviceName>
    <manufacturerName>Gyrus ACMI, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000034236</manufacturerSrn>
    <authorisedRepresentativeName>Olympus Europa SE &amp; Co. KG</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006774</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R9005</emdnCode>
    <emdnDescription>ENDOBRONCHIAL VALVES AND RELEASE SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IBV-V5</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T13:03:07.049Z</lastUpdated>
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  <row>
    <udiDi>00896506002019</udiDi>
    <basicUdiDi>B-00896506002019</basicUdiDi>
    <tradeName>Spiration Valve System</tradeName>
    <deviceName>Valve in Cartridge</deviceName>
    <manufacturerName>Gyrus ACMI, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000034236</manufacturerSrn>
    <authorisedRepresentativeName>Olympus Europa SE &amp; Co. KG</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006774</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R9005</emdnCode>
    <emdnDescription>ENDOBRONCHIAL VALVES AND RELEASE SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IBV-V6</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T13:03:06.255Z</lastUpdated>
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    <udiDi>00896506002002</udiDi>
    <basicUdiDi>B-00896506002002</basicUdiDi>
    <tradeName>Spiration Valve System</tradeName>
    <deviceName>Valve in Cartridge</deviceName>
    <manufacturerName>Gyrus ACMI, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000034236</manufacturerSrn>
    <authorisedRepresentativeName>Olympus Europa SE &amp; Co. KG</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006774</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>R9005</emdnCode>
    <emdnDescription>ENDOBRONCHIAL VALVES AND RELEASE SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IBV-V7</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T13:03:05.504Z</lastUpdated>
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    <udiDi>00821925027787</udiDi>
    <basicUdiDi>0821925000215B</basicUdiDi>
    <tradeName>00821925027787</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Gyrus ACMI, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000034237</manufacturerSrn>
    <authorisedRepresentativeName>Olympus Europa SE &amp; Co. KG</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006774</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MDFS100</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-19T19:49:16.283Z</lastUpdated>
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    <udiDi>00821925035669</udiDi>
    <basicUdiDi>08219250000257</basicUdiDi>
    <tradeName>00821925035669</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Gyrus ACMI, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000034237</manufacturerSrn>
    <authorisedRepresentativeName>Olympus Europa SE &amp; Co. KG</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006774</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HSDHP200TRAY</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-19T19:49:16.265Z</lastUpdated>
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    <udiDi>00821925035843</udiDi>
    <basicUdiDi>0821925000045B</basicUdiDi>
    <tradeName>00821925035843</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Gyrus ACMI, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000034237</manufacturerSrn>
    <authorisedRepresentativeName>Olympus Europa SE &amp; Co. KG</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006774</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HSDCK200</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-19T19:49:16.244Z</lastUpdated>
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    <udiDi>00821925041806</udiDi>
    <basicUdiDi>0821925000155G</basicUdiDi>
    <tradeName>00821925041806</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Gyrus ACMI, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000034237</manufacturerSrn>
    <authorisedRepresentativeName>Olympus Europa SE &amp; Co. KG</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006774</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PK-SP0533</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-19T19:49:16.189Z</lastUpdated>
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