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    <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>MDR 2017/745</legislation>
    <emdnCode>K0201010502</emdnCode>
    <emdnDescription>LAPAROSCOPIC AND THORACOSCOPIC ELECTROSURGERY HANDPIECES, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PS-0537CJDA</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-31T19:46:28.235Z</lastUpdated>
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    <udiDi>00821925044562</udiDi>
    <basicUdiDi>0821925000125A</basicUdiDi>
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    <deviceName></deviceName>
    <manufacturerName>Gyrus ACMI, Inc.</manufacturerName>
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    <authorisedRepresentativeName>Olympus Europa SE &amp; Co. KG</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006774</authorisedRepresentativeSrn>
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    <emdnDescription>LAPAROSCOPIC AND THORACOSCOPIC ELECTROSURGERY HANDPIECES, SINGLE-USE</emdnDescription>
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    <reference>PS-0544CJDA</reference>
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    <udiDi>00821925045057</udiDi>
    <basicUdiDi>0821925000125A</basicUdiDi>
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    <deviceName></deviceName>
    <manufacturerName>Gyrus ACMI, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000034237</manufacturerSrn>
    <authorisedRepresentativeName>Olympus Europa SE &amp; Co. KG</authorisedRepresentativeName>
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    <legislation>MDR 2017/745</legislation>
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    <emdnDescription>LAPAROSCOPIC AND THORACOSCOPIC ELECTROSURGERY HANDPIECES, SINGLE-USE</emdnDescription>
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    <udiDi>00821925045064</udiDi>
    <basicUdiDi>0821925000125A</basicUdiDi>
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    <deviceName></deviceName>
    <manufacturerName>Gyrus ACMI, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000034237</manufacturerSrn>
    <authorisedRepresentativeName>Olympus Europa SE &amp; Co. KG</authorisedRepresentativeName>
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    <legislation>MDR 2017/745</legislation>
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    <emdnDescription>LAPAROSCOPIC AND THORACOSCOPIC ELECTROSURGERY HANDPIECES, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PS-0537CJSA</reference>
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    <lastUpdated>2026-07-31T19:46:28.141Z</lastUpdated>
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    <udiDi>00821925040045</udiDi>
    <basicUdiDi>08219250001158</basicUdiDi>
    <tradeName>00821925040045</tradeName>
    <deviceName>Footpedal, Lens Cleaner</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>Z12029015</emdnCode>
    <emdnDescription>LENS CLEANING UNITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LCFP100</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-24T03:49:52.427Z</lastUpdated>
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    <udiDi>00821925035829</udiDi>
    <basicUdiDi>0821925000045B</basicUdiDi>
    <tradeName>00821925035829</tradeName>
    <deviceName>Debrider cleaning kits</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>V070105</emdnCode>
    <emdnDescription>INSTRUMENTS CLEANING BRUSHES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HSDCK200</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-23T19:42:47.497Z</lastUpdated>
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    <udiDi>00821925028111</udiDi>
    <basicUdiDi>0821925000155G</basicUdiDi>
    <tradeName>00821925028111</tradeName>
    <deviceName>Electrosurgical Bipolar Spatulas</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>K0201010501</emdnCode>
    <emdnDescription>OPEN ELECTROSURGERY HANDPIECES, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PK-SP0533</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-23T19:42:46.699Z</lastUpdated>
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    <udiDi>00821925027763</udiDi>
    <basicUdiDi>08219250000257</basicUdiDi>
    <tradeName>00821925027763</tradeName>
    <deviceName>Instrument sterilization trays</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>S010401</emdnCode>
    <emdnDescription>TRAYS, BASKETS, TUBS FOR STERILISATION AND THEIR COMPONENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MDHPTRAY</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-23T19:42:41.897Z</lastUpdated>
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    <udiDi>00821925039445</udiDi>
    <basicUdiDi>08219250000155</basicUdiDi>
    <tradeName>00821925039445</tradeName>
    <deviceName>ShockPulse lithotripsy accessories (nosecone, wrench, stylet)</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>Z12010880</emdnCode>
    <emdnDescription>INSTRUMENTS FOR ULTRASONIC SURGERY - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SPL-W</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-23T03:53:29.296Z</lastUpdated>
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    <udiDi>00821925010802</udiDi>
    <basicUdiDi>08219250000359</basicUdiDi>
    <tradeName>00821925010802</tradeName>
    <deviceName>PK CORD,NS</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>L181003</emdnCode>
    <emdnDescription>ELECTROSURGERY CONNECTION CABLES, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3900</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-23T03:53:28.498Z</lastUpdated>
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    <udiDi>00821925043671</udiDi>
    <basicUdiDi>08219250000155</basicUdiDi>
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    <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>MDR 2017/745</legislation>
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    <emdnDescription>INSTRUMENTS FOR ULTRASONIC SURGERY - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SPL-CSL</reference>
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    <lastUpdated>2026-07-23T03:49:19.920Z</lastUpdated>
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    <udiDi>00821925011526</udiDi>
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    <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>MDR 2017/745</legislation>
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    <emdnDescription>ELECTROSURGERY CONNECTION CABLES, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EC3999</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-23T03:49:01.422Z</lastUpdated>
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    <udiDi>00821925043701</udiDi>
    <basicUdiDi>08219250000155</basicUdiDi>
    <tradeName>00821925043701</tradeName>
    <deviceName>ShockPulse lithotripsy accessories (nosecone, wrench, stylet)</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>Z12010880</emdnCode>
    <emdnDescription>INSTRUMENTS FOR ULTRASONIC SURGERY - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SPL-NC</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-22T19:47:38.925Z</lastUpdated>
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    <udiDi>00821925044869</udiDi>
    <basicUdiDi>0821925000255K</basicUdiDi>
    <tradeName>00821925044869</tradeName>
    <deviceName>Disposable Microdebrider (DSD)</deviceName>
    <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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    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q030302</emdnCode>
    <emdnDescription>ENT SURGERY BURS AND HANDPIECES, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DSD4000SA</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-20T19:51:22.222Z</lastUpdated>
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    <manufacturerName>Gyrus ACMI, Inc.</manufacturerName>
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    <deviceStatus>Piyasada</deviceStatus>
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    <manufacturerName>Gyrus ACMI, Inc.</manufacturerName>
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    <tradeName>URETERO-RENO FIBERSCOPE OLYMPUS URF-P7</tradeName>
    <deviceName>Uretero-Reno Videoscope_Flexible Fibreoptic Ureterorenoscope</deviceName>
    <manufacturerName>OLYMPUS MEDICAL SYSTEMS CORP.</manufacturerName>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>N5781852</reference>
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    <tradeName>RIGHT/LEFT ANGURATION KNOB ATTACHMENT MAJ-1072</tradeName>
    <deviceName>Anguration Knob Attachment</deviceName>
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    <authorisedRepresentativeName>Olympus Europa SE &amp; Co. KG</authorisedRepresentativeName>
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    <reference>N6149450</reference>
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    <lastUpdated>2026-07-16T06:40:09.635Z</lastUpdated>
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