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    <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>
    <riskClass>Sınıf IIa</riskClass>
    <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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    <deviceName></deviceName>
    <manufacturerName>Gyrus ACMI, Inc.</manufacturerName>
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    <authorisedRepresentativeName>Olympus Europa SE &amp; Co. KG</authorisedRepresentativeName>
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    <emdnDescription>ENT SURGERY BURS AND HANDPIECES, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DSD2000BA</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
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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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    <emdnCode>Q030302</emdnCode>
    <emdnDescription>ENT SURGERY BURS AND HANDPIECES, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DSDPP100</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-20T19:46:08.128Z</lastUpdated>
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    <udiDi>00821925045170</udiDi>
    <basicUdiDi>0821925000255K</basicUdiDi>
    <tradeName>00821925045170</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 IIa</riskClass>
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    <emdnCode>Q030302</emdnCode>
    <emdnDescription>ENT SURGERY BURS AND HANDPIECES, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DSD40MMSC</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-20T19:46:08.108Z</lastUpdated>
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    <udiDi>00821925044883</udiDi>
    <basicUdiDi>0821925000255K</basicUdiDi>
    <tradeName>00821925044883</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 IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q030302</emdnCode>
    <emdnDescription>ENT SURGERY BURS AND HANDPIECES, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DSD4000BA</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-20T19:46:08.031Z</lastUpdated>
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    <udiDi>08904461036054</udiDi>
    <basicUdiDi>B-08904461036054</basicUdiDi>
    <tradeName>Osseous</tradeName>
    <deviceName>Burs-Course Diamond-6.0mm Sterile</deviceName>
    <manufacturerName>EON MEDITECH PVT. LTD</manufacturerName>
    <manufacturerSrn>IN-MF-000014457</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q030302</emdnCode>
    <emdnDescription>ENT SURGERY BURS AND HANDPIECES, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EI2160CD</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-10T16:37:57.345Z</lastUpdated>
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    <udiDi>08904461036047</udiDi>
    <basicUdiDi>B-08904461036047</basicUdiDi>
    <tradeName>Osseous</tradeName>
    <deviceName>Burs-Course Diamond-5.0mm Sterile</deviceName>
    <manufacturerName>EON MEDITECH PVT. LTD</manufacturerName>
    <manufacturerSrn>IN-MF-000014457</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
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    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q030302</emdnCode>
    <emdnDescription>ENT SURGERY BURS AND HANDPIECES, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EI2150CD</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-10T16:37:56.548Z</lastUpdated>
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    <udiDi>08904461036030</udiDi>
    <basicUdiDi>B-08904461036030</basicUdiDi>
    <tradeName>Osseous</tradeName>
    <deviceName>Burs-Course Diamond-4.5mm Sterile</deviceName>
    <manufacturerName>EON MEDITECH PVT. LTD</manufacturerName>
    <manufacturerSrn>IN-MF-000014457</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q030302</emdnCode>
    <emdnDescription>ENT SURGERY BURS AND HANDPIECES, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EI2145CD</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-10T16:37:52.576Z</lastUpdated>
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    <udiDi>08904461036023</udiDi>
    <basicUdiDi>B-08904461036023</basicUdiDi>
    <tradeName>Osseous</tradeName>
    <deviceName>Burs-Course Diamond-4.0mm Sterile</deviceName>
    <manufacturerName>EON MEDITECH PVT. LTD</manufacturerName>
    <manufacturerSrn>IN-MF-000014457</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q030302</emdnCode>
    <emdnDescription>ENT SURGERY BURS AND HANDPIECES, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EI2140CD</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-10T16:37:51.816Z</lastUpdated>
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  <row>
    <udiDi>08904461036016</udiDi>
    <basicUdiDi>B-08904461036016</basicUdiDi>
    <tradeName>Osseous</tradeName>
    <deviceName>Burs-Course Diamond-3.5mm Sterile</deviceName>
    <manufacturerName>EON MEDITECH PVT. LTD</manufacturerName>
    <manufacturerSrn>IN-MF-000014457</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q030302</emdnCode>
    <emdnDescription>ENT SURGERY BURS AND HANDPIECES, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EI2135CD</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-10T16:37:51.000Z</lastUpdated>
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    <udiDi>08904461036009</udiDi>
    <basicUdiDi>B-08904461036009</basicUdiDi>
    <tradeName>Osseous</tradeName>
    <deviceName>Burs-Course Diamond-3.0mm Sterile</deviceName>
    <manufacturerName>EON MEDITECH PVT. LTD</manufacturerName>
    <manufacturerSrn>IN-MF-000014457</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q030302</emdnCode>
    <emdnDescription>ENT SURGERY BURS AND HANDPIECES, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EI2130CD</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-10T16:37:50.157Z</lastUpdated>
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  <row>
    <udiDi>08904461035972</udiDi>
    <basicUdiDi>B-08904461035972</basicUdiDi>
    <tradeName>Osseous</tradeName>
    <deviceName>Burs-Course Diamond-1.5mm Sterile</deviceName>
    <manufacturerName>EON MEDITECH PVT. LTD</manufacturerName>
    <manufacturerSrn>IN-MF-000014457</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q030302</emdnCode>
    <emdnDescription>ENT SURGERY BURS AND HANDPIECES, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EI2115CD</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-10T16:37:46.164Z</lastUpdated>
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  <row>
    <udiDi>08904461035965</udiDi>
    <basicUdiDi>B-08904461035965</basicUdiDi>
    <tradeName>Osseous</tradeName>
    <deviceName>Burs-Course Diamond-1.0mm Sterile</deviceName>
    <manufacturerName>EON MEDITECH PVT. LTD</manufacturerName>
    <manufacturerSrn>IN-MF-000014457</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q030302</emdnCode>
    <emdnDescription>ENT SURGERY BURS AND HANDPIECES, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EI2110CD</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-10T16:37:45.499Z</lastUpdated>
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    <udiDi>08904461035996</udiDi>
    <basicUdiDi>B-08904461035996</basicUdiDi>
    <tradeName>Osseous</tradeName>
    <deviceName>Burs-Course Diamond-2.5mm Sterile</deviceName>
    <manufacturerName>EON MEDITECH PVT. LTD</manufacturerName>
    <manufacturerSrn>IN-MF-000014457</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q030302</emdnCode>
    <emdnDescription>ENT SURGERY BURS AND HANDPIECES, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EI2125CD</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-10T16:37:43.740Z</lastUpdated>
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    <udiDi>08904461035989</udiDi>
    <basicUdiDi>B-08904461035989</basicUdiDi>
    <tradeName>Osseous</tradeName>
    <deviceName>Burs-Course Diamond-2.0mm Sterile</deviceName>
    <manufacturerName>EON MEDITECH PVT. LTD</manufacturerName>
    <manufacturerSrn>IN-MF-000014457</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
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    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q030302</emdnCode>
    <emdnDescription>ENT SURGERY BURS AND HANDPIECES, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EI2120CD</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-10T16:37:43.032Z</lastUpdated>
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    <udiDi>08904461035958</udiDi>
    <basicUdiDi>B-08904461035958</basicUdiDi>
    <tradeName>Osseous</tradeName>
    <deviceName>Burs-Course Diamond-0.5mm Sterile</deviceName>
    <manufacturerName>EON MEDITECH PVT. LTD</manufacturerName>
    <manufacturerSrn>IN-MF-000014457</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
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    <riskClass>Sınıf IIa</riskClass>
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    <emdnDescription>ENT SURGERY BURS AND HANDPIECES, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EI2105CD</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-10T16:37:26.091Z</lastUpdated>
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    <udiDi>08904461035941</udiDi>
    <basicUdiDi>B-08904461035941</basicUdiDi>
    <tradeName>OSSEOUS</tradeName>
    <deviceName>Burs-Fine Diamond-6.0mm Sterile</deviceName>
    <manufacturerName>EON MEDITECH PVT. LTD</manufacturerName>
    <manufacturerSrn>IN-MF-000014457</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
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    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q030302</emdnCode>
    <emdnDescription>ENT SURGERY BURS AND HANDPIECES, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EI2160FD</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-10T16:37:25.290Z</lastUpdated>
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    <udiDi>08904461035934</udiDi>
    <basicUdiDi>B-08904461035934</basicUdiDi>
    <tradeName>OSSEOUS</tradeName>
    <deviceName>Burs-Fine Diamond-5.5mm Sterile</deviceName>
    <manufacturerName>EON MEDITECH PVT. LTD</manufacturerName>
    <manufacturerSrn>IN-MF-000014457</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
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    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
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    <emdnDescription>ENT SURGERY BURS AND HANDPIECES, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EI2155FD</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-10T16:37:25.048Z</lastUpdated>
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    <udiDi>08904461035927</udiDi>
    <basicUdiDi>B-08904461035927</basicUdiDi>
    <tradeName>OSSEOUS</tradeName>
    <deviceName>Burs-Fine Diamond-5.0mm Sterile</deviceName>
    <manufacturerName>EON MEDITECH PVT. LTD</manufacturerName>
    <manufacturerSrn>IN-MF-000014457</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
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    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q030302</emdnCode>
    <emdnDescription>ENT SURGERY BURS AND HANDPIECES, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EI2150FD</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-10T16:37:25.045Z</lastUpdated>
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    <udiDi>08904461035910</udiDi>
    <basicUdiDi>B-08904461035910</basicUdiDi>
    <tradeName>OSSEOUS</tradeName>
    <deviceName>Burs-Fine Diamond-4.5mm Sterile</deviceName>
    <manufacturerName>EON MEDITECH PVT. LTD</manufacturerName>
    <manufacturerSrn>IN-MF-000014457</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
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    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q030302</emdnCode>
    <emdnDescription>ENT SURGERY BURS AND HANDPIECES, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EI2145FD</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-10T16:37:19.686Z</lastUpdated>
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