<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>00821925035522</udiDi>
    <basicUdiDi>B-00821925035522</basicUdiDi>
    <tradeName>00821925035522</tradeName>
    <deviceName>SB4015SC</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>SB4015SC</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-09-21T20:16:04.081Z</lastUpdated>
  </row>
  <row>
    <udiDi>00821925035515</udiDi>
    <basicUdiDi>B-00821925035515</basicUdiDi>
    <tradeName>00821925035515</tradeName>
    <deviceName>SB4000SC</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>SB4000SC</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-09-21T20:16:02.481Z</lastUpdated>
  </row>
  <row>
    <udiDi>00821925035508</udiDi>
    <basicUdiDi>B-00821925035508</basicUdiDi>
    <tradeName>00821925035508</tradeName>
    <deviceName>SB2975SC</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>SB2975SC</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-09-21T20:16:00.085Z</lastUpdated>
  </row>
  <row>
    <udiDi>00821925035485</udiDi>
    <basicUdiDi>B-00821925035485</basicUdiDi>
    <tradeName>00821925035485</tradeName>
    <deviceName>BUR4260FB</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>BUR4260FB</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-09-21T20:15:58.467Z</lastUpdated>
  </row>
  <row>
    <udiDi>00821925028081</udiDi>
    <basicUdiDi>B-00821925028081</basicUdiDi>
    <tradeName>00821925028081</tradeName>
    <deviceName>LB4027SD</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>LB4027SD</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-09-21T20:15:57.672Z</lastUpdated>
  </row>
  <row>
    <udiDi>00821925035492</udiDi>
    <basicUdiDi>B-00821925035492</basicUdiDi>
    <tradeName>00821925035492</tradeName>
    <deviceName>SB2940SC</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>SB2940SC</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-09-21T20:15:55.360Z</lastUpdated>
  </row>
  <row>
    <udiDi>00821925028074</udiDi>
    <basicUdiDi>B-00821925028074</basicUdiDi>
    <tradeName>00821925028074</tradeName>
    <deviceName>LB4022SD</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>LB4022SD</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-09-21T20:15:41.613Z</lastUpdated>
  </row>
  <row>
    <udiDi>00821925028067</udiDi>
    <basicUdiDi>B-00821925028067</basicUdiDi>
    <tradeName>00821925028067</tradeName>
    <deviceName>LB2927SS</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>LB2927SS</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-09-21T20:15:37.601Z</lastUpdated>
  </row>
  <row>
    <udiDi>00821925028050</udiDi>
    <basicUdiDi>B-00821925028050</basicUdiDi>
    <tradeName>00821925028050</tradeName>
    <deviceName>LB2922SS</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>LB2922SS</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-09-21T20:15:36.801Z</lastUpdated>
  </row>
  <row>
    <udiDi>00821925027961</udiDi>
    <basicUdiDi>B-00821925027961</basicUdiDi>
    <tradeName>00821925027961</tradeName>
    <deviceName>BUR3070DB</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>BUR3070DB</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-09-21T20:15:36.013Z</lastUpdated>
  </row>
  <row>
    <udiDi>00821925027954</udiDi>
    <basicUdiDi>B-00821925027954</basicUdiDi>
    <tradeName>00821925027954</tradeName>
    <deviceName>BUR4215FB</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>BUR4215FB</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-09-21T20:15:35.215Z</lastUpdated>
  </row>
  <row>
    <udiDi>00821925027947</udiDi>
    <basicUdiDi>B-00821925027947</basicUdiDi>
    <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>
  </row>
  <row>
    <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>
  </row>
  <row>
    <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>
  </row>
  <row>
    <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>
  </row>
  <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>
  </row>
  <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>
  </row>
  <row>
    <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>
  </row>
  <row>
    <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>
  </row>
  <row>
    <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>
</eudamedExport>