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    <tradeName>00821925027947</tradeName>
    <deviceName>BUR4515BB</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>BUR4515BB</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-09-21T20:15:31.329Z</lastUpdated>
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    <udiDi>00821925027930</udiDi>
    <basicUdiDi>B-00821925027930</basicUdiDi>
    <tradeName>00821925027930</tradeName>
    <deviceName>BUR3015DB</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>BUR3015DB</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-09-21T20:15:29.599Z</lastUpdated>
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    <udiDi>00821925027923</udiDi>
    <basicUdiDi>B-00821925027923</basicUdiDi>
    <tradeName>00821925027923</tradeName>
    <deviceName>BUR4015DT</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>BUR4015DT</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-09-21T20:15:28.809Z</lastUpdated>
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    <udiDi>00821925027916</udiDi>
    <basicUdiDi>B-00821925027916</basicUdiDi>
    <tradeName>00821925027916</tradeName>
    <deviceName>BUR4070DT</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>BUR4070DT</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-09-21T20:15:27.996Z</lastUpdated>
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  <row>
    <udiDi>00821925027909</udiDi>
    <basicUdiDi>B-00821925027909</basicUdiDi>
    <tradeName>00821925027909</tradeName>
    <deviceName>SB4000SA</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>SB4000SA</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-09-21T20:15:23.998Z</lastUpdated>
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  <row>
    <udiDi>00821925027893</udiDi>
    <basicUdiDi>B-00821925027893</basicUdiDi>
    <tradeName>00821925027893</tradeName>
    <deviceName>SB2000SA</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>SB2000SA</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-09-21T20:15:23.209Z</lastUpdated>
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    <udiDi>00821925027886</udiDi>
    <basicUdiDi>B-00821925027886</basicUdiDi>
    <tradeName>00821925027886</tradeName>
    <deviceName>BB2000SA</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>BB2000SA</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-09-21T20:15:22.409Z</lastUpdated>
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    <udiDi>00821925044098</udiDi>
    <basicUdiDi>B-00821925044098</basicUdiDi>
    <tradeName>00821925044098</tradeName>
    <deviceName>TFL-FBX940R</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>MDD</legislation>
    <emdnCode>Z120615</emdnCode>
    <emdnDescription>THERAPEUTIC LASERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TFL-FBX940R</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-09-21T20:08:20.506Z</lastUpdated>
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    <udiDi>00821925044074</udiDi>
    <basicUdiDi>B-00821925044074</basicUdiDi>
    <tradeName>00821925044074</tradeName>
    <deviceName>TFL-FBX940S</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>MDD</legislation>
    <emdnCode>Z120615</emdnCode>
    <emdnDescription>THERAPEUTIC LASERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TFL-FBX940S</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-09-21T20:08:18.859Z</lastUpdated>
  </row>
  <row>
    <udiDi>00821925044050</udiDi>
    <basicUdiDi>B-00821925044050</basicUdiDi>
    <tradeName>00821925044050</tradeName>
    <deviceName>TFL-FBX550R</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>MDD</legislation>
    <emdnCode>Z120615</emdnCode>
    <emdnDescription>THERAPEUTIC LASERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TFL-FBX550R</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-09-21T20:08:15.664Z</lastUpdated>
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  <row>
    <udiDi>00821925044036</udiDi>
    <basicUdiDi>B-00821925044036</basicUdiDi>
    <tradeName>00821925044036</tradeName>
    <deviceName>TFL-FBX550S</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>MDD</legislation>
    <emdnCode>Z120615</emdnCode>
    <emdnDescription>THERAPEUTIC LASERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TFL-FBX550S</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-09-21T20:08:14.250Z</lastUpdated>
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  <row>
    <udiDi>00821925044012</udiDi>
    <basicUdiDi>B-00821925044012</basicUdiDi>
    <tradeName>00821925044012</tradeName>
    <deviceName>TFL-FBX365R</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>MDD</legislation>
    <emdnCode>Z120615</emdnCode>
    <emdnDescription>THERAPEUTIC LASERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TFL-FBX365R</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-09-21T20:08:13.254Z</lastUpdated>
  </row>
  <row>
    <udiDi>00821925043992</udiDi>
    <basicUdiDi>B-00821925043992</basicUdiDi>
    <tradeName>00821925043992</tradeName>
    <deviceName>TFL-FBX365S</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>MDD</legislation>
    <emdnCode>Z120615</emdnCode>
    <emdnDescription>THERAPEUTIC LASERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TFL-FBX365S</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-09-21T20:08:11.653Z</lastUpdated>
  </row>
  <row>
    <udiDi>00821925043978</udiDi>
    <basicUdiDi>B-00821925043978</basicUdiDi>
    <tradeName>00821925043978</tradeName>
    <deviceName>TFL-FBX200BS</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>MDD</legislation>
    <emdnCode>Z120615</emdnCode>
    <emdnDescription>THERAPEUTIC LASERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TFL-FBX200BS</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-09-21T20:08:09.365Z</lastUpdated>
  </row>
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    <udiDi>00821925043954</udiDi>
    <basicUdiDi>B-00821925043954</basicUdiDi>
    <tradeName>00821925043954</tradeName>
    <deviceName>TFL-FBX200R</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>MDD</legislation>
    <emdnCode>Z120615</emdnCode>
    <emdnDescription>THERAPEUTIC LASERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TFL-FBX200R</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-09-21T20:08:06.853Z</lastUpdated>
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    <udiDi>00821925043930</udiDi>
    <basicUdiDi>B-00821925043930</basicUdiDi>
    <tradeName>00821925043930</tradeName>
    <deviceName>TFL-FBX200S</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>MDD</legislation>
    <emdnCode>Z120615</emdnCode>
    <emdnDescription>THERAPEUTIC LASERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TFL-FBX200S</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-09-21T20:08:06.049Z</lastUpdated>
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    <udiDi>00821925043916</udiDi>
    <basicUdiDi>B-00821925043916</basicUdiDi>
    <tradeName>00821925043916</tradeName>
    <deviceName>TFL-FBX150BS</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>MDD</legislation>
    <emdnCode>Z120615</emdnCode>
    <emdnDescription>THERAPEUTIC LASERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TFL-FBX150BS</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-09-21T20:08:04.472Z</lastUpdated>
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    <udiDi>00821925043893</udiDi>
    <basicUdiDi>B-00821925043893</basicUdiDi>
    <tradeName>00821925043893</tradeName>
    <deviceName>TFL-FBX150R</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>MDD</legislation>
    <emdnCode>Z120615</emdnCode>
    <emdnDescription>THERAPEUTIC LASERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TFL-FBX150R</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-09-21T20:08:02.112Z</lastUpdated>
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    <udiDi>00821925031852</udiDi>
    <basicUdiDi>B-00821925031852</basicUdiDi>
    <tradeName>00821925031852</tradeName>
    <deviceName>SSC8532</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>MDD</legislation>
    <emdnCode>U020399</emdnCode>
    <emdnDescription>URETERAL STENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SSC8532</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-09-21T20:08:00.447Z</lastUpdated>
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    <udiDi>00821925031845</udiDi>
    <basicUdiDi>B-00821925031845</basicUdiDi>
    <tradeName>00821925031845</tradeName>
    <deviceName>SSC8530</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>MDD</legislation>
    <emdnCode>U020399</emdnCode>
    <emdnDescription>URETERAL STENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SSC8530</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-09-21T20:07:59.107Z</lastUpdated>
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