<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>04961333239023</udiDi>
    <basicUdiDi>B-04961333239023</basicUdiDi>
    <tradeName>PORTABLE INTUBATIONSCOPE FI-BS SERIES</tradeName>
    <deviceName>PORTABLE INTUBATIONSCOPE FI-BS SERIES FI-10RBS</deviceName>
    <manufacturerName>HOYA Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000005227</manufacturerSrn>
    <authorisedRepresentativeName>PENTAX Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000006</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12029006</emdnCode>
    <emdnDescription>FIBROSCOPES FOR INTUBATION</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>04961333239023</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T14:37:24.532Z</lastUpdated>
  </row>
  <row>
    <udiDi>04961333239009</udiDi>
    <basicUdiDi>B-04961333239009</basicUdiDi>
    <tradeName>PORTABLE INTUBATIONSCOPE FI-BS SERIES</tradeName>
    <deviceName>PORTABLE INTUBATIONSCOPE FI-BS SERIES FI-16RBS</deviceName>
    <manufacturerName>HOYA Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000005227</manufacturerSrn>
    <authorisedRepresentativeName>PENTAX Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000006</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12029006</emdnCode>
    <emdnDescription>FIBROSCOPES FOR INTUBATION</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>04961333239009</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T14:37:22.130Z</lastUpdated>
  </row>
  <row>
    <udiDi>04961333238989</udiDi>
    <basicUdiDi>B-04961333238989</basicUdiDi>
    <tradeName>BRONCHO FIBERSCOPE FB-8V</tradeName>
    <deviceName>BRONCHO FIBERSCOPE FB-8V</deviceName>
    <manufacturerName>HOYA Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000005227</manufacturerSrn>
    <authorisedRepresentativeName>PENTAX Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000006</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12020801</emdnCode>
    <emdnDescription>BRONCHOSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>04961333238989</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T14:37:20.546Z</lastUpdated>
  </row>
  <row>
    <udiDi>04961333238910</udiDi>
    <basicUdiDi>B-04961333238910</basicUdiDi>
    <tradeName>BRONCHO FIBERSCOPE FB-V SERIES</tradeName>
    <deviceName>BRONCHO FIBERSCOPE FB-V SERIES FB-15V</deviceName>
    <manufacturerName>HOYA Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000005227</manufacturerSrn>
    <authorisedRepresentativeName>PENTAX Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000006</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12020801</emdnCode>
    <emdnDescription>BRONCHOSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>04961333238910</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T14:37:19.738Z</lastUpdated>
  </row>
  <row>
    <udiDi>04961333238897</udiDi>
    <basicUdiDi>B-04961333238897</basicUdiDi>
    <tradeName>PORTABLE BRONCHOSCOPE FB-15RBS</tradeName>
    <deviceName>PORTABLE BRONCHOSCOPE FB-15RBS</deviceName>
    <manufacturerName>HOYA Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000005227</manufacturerSrn>
    <authorisedRepresentativeName>PENTAX Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000006</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12020801</emdnCode>
    <emdnDescription>BRONCHOSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>04961333238897</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T14:37:18.127Z</lastUpdated>
  </row>
  <row>
    <udiDi>04961333238873</udiDi>
    <basicUdiDi>B-04961333238873</basicUdiDi>
    <tradeName>PORTABLE BRONCHOSCOPE FB-18RBS</tradeName>
    <deviceName>PORTABLE BRONCHOSCOPE FB-18RBS</deviceName>
    <manufacturerName>HOYA Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000005227</manufacturerSrn>
    <authorisedRepresentativeName>PENTAX Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000006</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12020801</emdnCode>
    <emdnDescription>BRONCHOSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>04961333238873</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T14:37:15.741Z</lastUpdated>
  </row>
  <row>
    <udiDi>04961333238859</udiDi>
    <basicUdiDi>B-04961333238859</basicUdiDi>
    <tradeName>NASO-PHARYNGO-LARYNGOFIBERSCOPE FNL-RP3 SERIES</tradeName>
    <deviceName>NASO-PHARYNGO-LARYNGOFIBERSCOPE FNL-RP3 SERIES FNL-7RP3</deviceName>
    <manufacturerName>HOYA Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000005227</manufacturerSrn>
    <authorisedRepresentativeName>PENTAX Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000006</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12021005</emdnCode>
    <emdnDescription>NASAL PHARYNGO/LARYNGOSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>04961333238859</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T14:37:13.323Z</lastUpdated>
  </row>
  <row>
    <udiDi>04961333238835</udiDi>
    <basicUdiDi>B-04961333238835</basicUdiDi>
    <tradeName>NASO-PHARYNGO-LARYNGOFIBERSCOPE FNL-RP3 SERIES</tradeName>
    <deviceName>NASO-PHARYNGO-LARYNGOFIBERSCOPE FNL-RP3 SERIES FNL-10RP3</deviceName>
    <manufacturerName>HOYA Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000005227</manufacturerSrn>
    <authorisedRepresentativeName>PENTAX Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000006</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12021005</emdnCode>
    <emdnDescription>NASAL PHARYNGO/LARYNGOSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>04961333238835</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T14:37:12.525Z</lastUpdated>
  </row>
  <row>
    <udiDi>04961333238781</udiDi>
    <basicUdiDi>B-04961333238781</basicUdiDi>
    <tradeName>PORTABLE NASO-PHARYNGO-LARYNGOSCOPE FNL-10RBS</tradeName>
    <deviceName>PORTABLE NASO-PHARYNGO-LARYNGOSCOPE FNL-10RBS</deviceName>
    <manufacturerName>HOYA Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000005227</manufacturerSrn>
    <authorisedRepresentativeName>PENTAX Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000006</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12021005</emdnCode>
    <emdnDescription>NASAL PHARYNGO/LARYNGOSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>04961333238781</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T14:37:10.926Z</lastUpdated>
  </row>
  <row>
    <udiDi>04961333238095</udiDi>
    <basicUdiDi>B-04961333238095</basicUdiDi>
    <tradeName>PENTAX LH-150PC</tradeName>
    <deviceName>PENTAX Halogen Light Source LH-150PC</deviceName>
    <manufacturerName>HOYA Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000005227</manufacturerSrn>
    <authorisedRepresentativeName>PENTAX Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000006</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12020402</emdnCode>
    <emdnDescription>LIGHT SOURCES FOR ENDOSCOPY AND MINIMALLY INVASIVE SURGERY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>04961333238095</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T14:37:08.511Z</lastUpdated>
  </row>
  <row>
    <udiDi>04961333237401</udiDi>
    <basicUdiDi>B-04961333237401</basicUdiDi>
    <tradeName>PORTABLE INTUBATIONSCOPE FI-BS SERIES</tradeName>
    <deviceName>PORTABLE INTUBATIONSCOPE FI-BS SERIES FI-13RBS</deviceName>
    <manufacturerName>HOYA Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000005227</manufacturerSrn>
    <authorisedRepresentativeName>PENTAX Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000006</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12029006</emdnCode>
    <emdnDescription>FIBROSCOPES FOR INTUBATION</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>04961333237401</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T14:37:06.208Z</lastUpdated>
  </row>
  <row>
    <udiDi>04961333237357</udiDi>
    <basicUdiDi>B-04961333237357</basicUdiDi>
    <tradeName>GASTRO FIBERSCOPE FG-29V</tradeName>
    <deviceName>GASTRO FIBERSCOPE FG-29V</deviceName>
    <manufacturerName>HOYA Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000005227</manufacturerSrn>
    <authorisedRepresentativeName>PENTAX Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000006</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12020506</emdnCode>
    <emdnDescription>GASTROSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>04961333237357</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T14:37:05.409Z</lastUpdated>
  </row>
  <row>
    <udiDi>04961333237241</udiDi>
    <basicUdiDi>B-04961333237241</basicUdiDi>
    <tradeName>COLONO FIBERSCOPE FC-38V SERIES</tradeName>
    <deviceName>COLONO FIBERSCOPE FC-38V SERIES FC-38LV</deviceName>
    <manufacturerName>HOYA Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000005227</manufacturerSrn>
    <authorisedRepresentativeName>PENTAX Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000006</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12020601</emdnCode>
    <emdnDescription>COLONOSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>04961333237241</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T14:37:03.837Z</lastUpdated>
  </row>
  <row>
    <udiDi>04961333237166</udiDi>
    <basicUdiDi>B-04961333237166</basicUdiDi>
    <tradeName>BRONCHO FIBERSCOPE FB-V SERIES</tradeName>
    <deviceName>BRONCHO FIBERSCOPE FB-V SERIES FB-18V</deviceName>
    <manufacturerName>HOYA Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000005227</manufacturerSrn>
    <authorisedRepresentativeName>PENTAX Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000006</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12020801</emdnCode>
    <emdnDescription>BRONCHOSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>04961333237166</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T14:37:00.614Z</lastUpdated>
  </row>
  <row>
    <udiDi>04961333237036</udiDi>
    <basicUdiDi>B-04961333237036</basicUdiDi>
    <tradeName>PENTAX VIDEO UPPER G.I. SCOPE EG-3890TK</tradeName>
    <deviceName>PENTAX VIDEO UPPER G.I. SCOPE EG-3890TK</deviceName>
    <manufacturerName>HOYA Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000005227</manufacturerSrn>
    <authorisedRepresentativeName>PENTAX Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000006</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12020511</emdnCode>
    <emdnDescription>VIDEO GASTROSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>04961333237036</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T14:36:58.919Z</lastUpdated>
  </row>
  <row>
    <udiDi>04961333236657</udiDi>
    <basicUdiDi>B-04961333236657</basicUdiDi>
    <tradeName>PENTAX VIDEO UPPER G.I. SCOPE EG-2490K</tradeName>
    <deviceName>PENTAX VIDEO UPPER G.I. SCOPE EG-2490K</deviceName>
    <manufacturerName>HOYA Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000005227</manufacturerSrn>
    <authorisedRepresentativeName>PENTAX Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000006</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12020511</emdnCode>
    <emdnDescription>VIDEO GASTROSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>04961333236657</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T14:36:54.911Z</lastUpdated>
  </row>
  <row>
    <udiDi>04961333235971</udiDi>
    <basicUdiDi>B-04961333235971</basicUdiDi>
    <tradeName>VIDEO UPPER G.I. SCOPE EG-2990K</tradeName>
    <deviceName>VIDEO UPPER G.I. SCOPE EG-2990K</deviceName>
    <manufacturerName>HOYA Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000005227</manufacturerSrn>
    <authorisedRepresentativeName>PENTAX Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000006</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12020511</emdnCode>
    <emdnDescription>VIDEO GASTROSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>04961333235971</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T14:36:50.918Z</lastUpdated>
  </row>
  <row>
    <udiDi>04961333235261</udiDi>
    <basicUdiDi>B-04961333235261</basicUdiDi>
    <tradeName>PENTAX VIDEO UPPER G.I. SCOPE EG-2990Zi</tradeName>
    <deviceName>PENTAX VIDEO UPPER G.I. SCOPE EG-2990Zi</deviceName>
    <manufacturerName>HOYA Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000005227</manufacturerSrn>
    <authorisedRepresentativeName>PENTAX Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000006</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12020511</emdnCode>
    <emdnDescription>VIDEO GASTROSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>04961333235261</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T14:36:46.294Z</lastUpdated>
  </row>
  <row>
    <udiDi>04961333235230</udiDi>
    <basicUdiDi>B-04961333235230</basicUdiDi>
    <tradeName>PENTAX VIDEO DUODENOSCOPE ED34-i10T</tradeName>
    <deviceName>PENTAX VIDEO DUODENOSCOPE ED34-i10T</deviceName>
    <manufacturerName>HOYA Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000005227</manufacturerSrn>
    <authorisedRepresentativeName>PENTAX Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000006</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12020510</emdnCode>
    <emdnDescription>VIDEO GASTRODUODENOSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>04961333235230</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T14:36:46.292Z</lastUpdated>
  </row>
  <row>
    <udiDi>04961333234868</udiDi>
    <basicUdiDi>B-04961333234868</basicUdiDi>
    <tradeName>PENTAX VIDEO UPPER G.I. SCOPE EG27-i10</tradeName>
    <deviceName>PENTAX VIDEO UPPER G.I. SCOPE EG27-i10</deviceName>
    <manufacturerName>HOYA Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000005227</manufacturerSrn>
    <authorisedRepresentativeName>PENTAX Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000006</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12020511</emdnCode>
    <emdnDescription>VIDEO GASTROSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>04961333234868</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T14:36:26.018Z</lastUpdated>
  </row>
</eudamedExport>