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    <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 IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U020302</emdnCode>
    <emdnDescription>DOUBLE LOOP URETERAL STENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5608520</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-09-21T15:54:14.162Z</lastUpdated>
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    <udiDi>00821925003972</udiDi>
    <basicUdiDi>B-00821925003972</basicUdiDi>
    <tradeName>00821925003972</tradeName>
    <deviceName>5606022</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 IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U020302</emdnCode>
    <emdnDescription>DOUBLE LOOP URETERAL STENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5606022</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-09-21T15:54:09.396Z</lastUpdated>
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    <tradeName>00821925003910</tradeName>
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    <manufacturerName>Gyrus ACMI, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000034237</manufacturerSrn>
    <authorisedRepresentativeName>Olympus Europa SE &amp; Co. KG</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006774</authorisedRepresentativeSrn>
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    <emdnCode>U020302</emdnCode>
    <emdnDescription>DOUBLE LOOP URETERAL STENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5604512</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-09-21T15:54:08.558Z</lastUpdated>
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    <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 IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U020302</emdnCode>
    <emdnDescription>DOUBLE LOOP URETERAL STENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5608530</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-09-21T15:54:07.759Z</lastUpdated>
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    <udiDi>00821925003576</udiDi>
    <basicUdiDi>B-00821925003576</basicUdiDi>
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    <deviceName>5607024</deviceName>
    <manufacturerName>Gyrus ACMI, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000034237</manufacturerSrn>
    <authorisedRepresentativeName>Olympus Europa SE &amp; Co. KG</authorisedRepresentativeName>
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    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U020302</emdnCode>
    <emdnDescription>DOUBLE LOOP URETERAL STENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5607024</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-09-21T15:54:06.959Z</lastUpdated>
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    <udiDi>00821925003514</udiDi>
    <basicUdiDi>B-00821925003514</basicUdiDi>
    <tradeName>00821925003514</tradeName>
    <deviceName>5608526</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 IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U020302</emdnCode>
    <emdnDescription>DOUBLE LOOP URETERAL STENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5608526</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-09-21T15:54:02.160Z</lastUpdated>
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    <udiDi>00821925003507</udiDi>
    <basicUdiDi>B-00821925003507</basicUdiDi>
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    <deviceName>5604518</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 IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U020302</emdnCode>
    <emdnDescription>DOUBLE LOOP URETERAL STENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5604518</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-09-21T15:54:01.362Z</lastUpdated>
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    <udiDi>00821925003118</udiDi>
    <basicUdiDi>B-00821925003118</basicUdiDi>
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    <deviceName>5604508</deviceName>
    <manufacturerName>Gyrus ACMI, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000034237</manufacturerSrn>
    <authorisedRepresentativeName>Olympus Europa SE &amp; Co. KG</authorisedRepresentativeName>
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    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U020302</emdnCode>
    <emdnDescription>DOUBLE LOOP URETERAL STENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5604508</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-09-21T15:54:00.567Z</lastUpdated>
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    <udiDi>00821925003088</udiDi>
    <basicUdiDi>B-00821925003088</basicUdiDi>
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    <deviceName>5606020</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 IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U020302</emdnCode>
    <emdnDescription>DOUBLE LOOP URETERAL STENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5606020</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-09-21T15:53:59.761Z</lastUpdated>
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    <udiDi>00821925003033</udiDi>
    <basicUdiDi>B-00821925003033</basicUdiDi>
    <tradeName>00821925003033</tradeName>
    <deviceName>5604530</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 IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U020302</emdnCode>
    <emdnDescription>DOUBLE LOOP URETERAL STENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5604530</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-09-21T15:53:54.958Z</lastUpdated>
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    <udiDi>00821925003026</udiDi>
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    <tradeName>00821925003026</tradeName>
    <deviceName>5606030</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 IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U020302</emdnCode>
    <emdnDescription>DOUBLE LOOP URETERAL STENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5606030</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-09-21T15:53:54.156Z</lastUpdated>
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    <udiDi>00821925002883</udiDi>
    <basicUdiDi>B-00821925002883</basicUdiDi>
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    <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 IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U020302</emdnCode>
    <emdnDescription>DOUBLE LOOP URETERAL STENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5604510</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-09-21T15:53:53.358Z</lastUpdated>
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    <udiDi>00821925002357</udiDi>
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    <manufacturerName>Gyrus ACMI, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000034237</manufacturerSrn>
    <authorisedRepresentativeName>Olympus Europa SE &amp; Co. KG</authorisedRepresentativeName>
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    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U020302</emdnCode>
    <emdnDescription>DOUBLE LOOP URETERAL STENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5608528</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-09-21T15:53:52.593Z</lastUpdated>
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    <deviceName>Digital Data Recorders (Video Equipment)</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>MDR 2017/745</legislation>
    <emdnCode>V92</emdnCode>
    <emdnDescription>MEDICAL DEVICE SOFTWARE - NOT INCLUDED IN OTHER CLASSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ISM-1200483</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-04T17:56:54.308Z</lastUpdated>
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    <udiDi>00821925044524</udiDi>
    <basicUdiDi>0821925000125A</basicUdiDi>
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    <deviceName>PowerSeal electrosurgical handpiece</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>MDR 2017/745</legislation>
    <emdnCode>K0201010502</emdnCode>
    <emdnDescription>LAPAROSCOPIC AND THORACOSCOPIC ELECTROSURGERY HANDPIECES, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PS-0523CJDA</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-04T17:56:53.498Z</lastUpdated>
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    <deviceName>ShockPulse Accessories - power cord, footswitch</deviceName>
    <manufacturerName>Gyrus ACMI, Inc.</manufacturerName>
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    <emdnDescription>INSTRUMENTS FOR ULTRASONIC SURGERY - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SPL-FS</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-04T17:56:52.693Z</lastUpdated>
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    <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>MDR 2017/745</legislation>
    <emdnCode>Z12010902</emdnCode>
    <emdnDescription>ELECTROSURGICAL UNITS (ESU) FOR GENERAL USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>744010</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-04T17:56:48.689Z</lastUpdated>
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    <deviceName>ESIP System Pack</deviceName>
    <manufacturerName>Gyrus ACMI, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000034237</manufacturerSrn>
    <authorisedRepresentativeName>Olympus Europa SE &amp; Co. KG</authorisedRepresentativeName>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>ISM-1200374</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-04T17:56:15.032Z</lastUpdated>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>SPL-PC</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
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    <manufacturerName>Gyrus ACMI, Inc.</manufacturerName>
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    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry></placedOnMarketCountry>
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