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    <tradeName>00821925043091</tradeName>
    <deviceName>BB4040SC</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>Q030302</emdnCode>
    <emdnDescription>ENT SURGERY BURS AND HANDPIECES, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BB4040SC</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-09-21T20:18:27.466Z</lastUpdated>
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    <udiDi>00821925037007</udiDi>
    <basicUdiDi>B-00821925037007</basicUdiDi>
    <tradeName>00821925037007</tradeName>
    <deviceName>STAPBUR20D</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>Q030302</emdnCode>
    <emdnDescription>ENT SURGERY BURS AND HANDPIECES, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>STAPBUR20D</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-09-21T20:18:24.261Z</lastUpdated>
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    <udiDi>00821925036994</udiDi>
    <basicUdiDi>B-00821925036994</basicUdiDi>
    <tradeName>00821925036994</tradeName>
    <deviceName>STAPBUR17D</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>Q030302</emdnCode>
    <emdnDescription>ENT SURGERY BURS AND HANDPIECES, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>STAPBUR17D</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-09-21T20:18:21.857Z</lastUpdated>
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    <udiDi>00821925036970</udiDi>
    <basicUdiDi>B-00821925036970</basicUdiDi>
    <tradeName>00821925036970</tradeName>
    <deviceName>STAPBUR08D</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>Q030302</emdnCode>
    <emdnDescription>ENT SURGERY BURS AND HANDPIECES, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>STAPBUR08D</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-09-21T20:18:20.890Z</lastUpdated>
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    <udiDi>00821925036987</udiDi>
    <basicUdiDi>B-00821925036987</basicUdiDi>
    <tradeName>00821925036987</tradeName>
    <deviceName>STAPBUR10D</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>Q030302</emdnCode>
    <emdnDescription>ENT SURGERY BURS AND HANDPIECES, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>STAPBUR10D</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-09-21T20:18:20.386Z</lastUpdated>
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    <udiDi>00821925036963</udiDi>
    <basicUdiDi>B-00821925036963</basicUdiDi>
    <tradeName>00821925036963</tradeName>
    <deviceName>STAPBUR07D</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>Q030302</emdnCode>
    <emdnDescription>ENT SURGERY BURS AND HANDPIECES, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>STAPBUR07D</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-09-21T20:18:17.853Z</lastUpdated>
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    <udiDi>00821925036956</udiDi>
    <basicUdiDi>B-00821925036956</basicUdiDi>
    <tradeName>00821925036956</tradeName>
    <deviceName>STAPBUR06D</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>Q030302</emdnCode>
    <emdnDescription>ENT SURGERY BURS AND HANDPIECES, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>STAPBUR06D</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-09-21T20:18:15.456Z</lastUpdated>
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    <udiDi>00821925036949</udiDi>
    <basicUdiDi>B-00821925036949</basicUdiDi>
    <tradeName>00821925036949</tradeName>
    <deviceName>STAPBUR05D</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>Q030302</emdnCode>
    <emdnDescription>ENT SURGERY BURS AND HANDPIECES, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>STAPBUR05D</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-09-21T20:18:13.841Z</lastUpdated>
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  <row>
    <udiDi>00821925036932</udiDi>
    <basicUdiDi>B-00821925036932</basicUdiDi>
    <tradeName>00821925036932</tradeName>
    <deviceName>MBUR7080DSC</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>Q030302</emdnCode>
    <emdnDescription>ENT SURGERY BURS AND HANDPIECES, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MBUR7080DSC</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-09-21T20:18:13.048Z</lastUpdated>
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    <udiDi>00821925036925</udiDi>
    <basicUdiDi>B-00821925036925</basicUdiDi>
    <tradeName>00821925036925</tradeName>
    <deviceName>MBUR6080DSC</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>Q030302</emdnCode>
    <emdnDescription>ENT SURGERY BURS AND HANDPIECES, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MBUR6080DSC</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-09-21T20:18:10.648Z</lastUpdated>
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    <udiDi>00821925036918</udiDi>
    <basicUdiDi>B-00821925036918</basicUdiDi>
    <tradeName>00821925036918</tradeName>
    <deviceName>MBUR5080DSC</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>Q030302</emdnCode>
    <emdnDescription>ENT SURGERY BURS AND HANDPIECES, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MBUR5080DSC</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-09-21T20:18:08.250Z</lastUpdated>
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    <udiDi>00821925036901</udiDi>
    <basicUdiDi>B-00821925036901</basicUdiDi>
    <tradeName>00821925036901</tradeName>
    <deviceName>MBUR4080DSC</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>Q030302</emdnCode>
    <emdnDescription>ENT SURGERY BURS AND HANDPIECES, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MBUR4080DSC</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-09-21T20:18:06.649Z</lastUpdated>
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    <udiDi>00821925036895</udiDi>
    <basicUdiDi>B-00821925036895</basicUdiDi>
    <tradeName>00821925036895</tradeName>
    <deviceName>MBUR7060DSC</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>Q030302</emdnCode>
    <emdnDescription>ENT SURGERY BURS AND HANDPIECES, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MBUR7060DSC</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-09-21T20:18:05.843Z</lastUpdated>
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    <udiDi>00821925036888</udiDi>
    <basicUdiDi>B-00821925036888</basicUdiDi>
    <tradeName>00821925036888</tradeName>
    <deviceName>MBUR6060DSC</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>Q030302</emdnCode>
    <emdnDescription>ENT SURGERY BURS AND HANDPIECES, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MBUR6060DSC</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-09-21T20:18:04.247Z</lastUpdated>
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    <udiDi>00821925036871</udiDi>
    <basicUdiDi>B-00821925036871</basicUdiDi>
    <tradeName>00821925036871</tradeName>
    <deviceName>MBUR5060DSC</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>Q030302</emdnCode>
    <emdnDescription>ENT SURGERY BURS AND HANDPIECES, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MBUR5060DSC</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-09-21T20:18:01.836Z</lastUpdated>
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    <udiDi>00821925036819</udiDi>
    <basicUdiDi>B-00821925036819</basicUdiDi>
    <tradeName>00821925036819</tradeName>
    <deviceName>MBUR7060DVC</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>Q030302</emdnCode>
    <emdnDescription>ENT SURGERY BURS AND HANDPIECES, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MBUR7060DVC</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-09-21T20:18:00.245Z</lastUpdated>
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    <udiDi>00821925036802</udiDi>
    <basicUdiDi>B-00821925036802</basicUdiDi>
    <tradeName>00821925036802</tradeName>
    <deviceName>MBUR6060DVC</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>Q030302</emdnCode>
    <emdnDescription>ENT SURGERY BURS AND HANDPIECES, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MBUR6060DVC</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-09-21T20:17:59.565Z</lastUpdated>
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    <udiDi>00821925036864</udiDi>
    <basicUdiDi>B-00821925036864</basicUdiDi>
    <tradeName>00821925036864</tradeName>
    <deviceName>MBUR4060DSC</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>Q030302</emdnCode>
    <emdnDescription>ENT SURGERY BURS AND HANDPIECES, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MBUR4060DSC</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-09-21T20:17:57.122Z</lastUpdated>
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    <udiDi>00821925036796</udiDi>
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    <tradeName>00821925036796</tradeName>
    <deviceName>MBUR5060DVC</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>Q030302</emdnCode>
    <emdnDescription>ENT SURGERY BURS AND HANDPIECES, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MBUR5060DVC</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-09-21T20:17:43.382Z</lastUpdated>
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    <basicUdiDi>B-00821925036789</basicUdiDi>
    <tradeName>00821925036789</tradeName>
    <deviceName>MBUR4060DVC</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>Q030302</emdnCode>
    <emdnDescription>ENT SURGERY BURS AND HANDPIECES, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MBUR4060DVC</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-09-21T20:17:38.584Z</lastUpdated>
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