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    <basicUdiDi>859911004ShotBlockerMT</basicUdiDi>
    <tradeName>ShotBlocker</tradeName>
    <deviceName>ShotBlocker</deviceName>
    <manufacturerName>Bionix LLC</manufacturerName>
    <manufacturerSrn>US-MF-000020408</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>V9099</emdnCode>
    <emdnDescription>VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8050</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-03T14:00:59.281Z</lastUpdated>
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    <udiDi>00859911004757</udiDi>
    <basicUdiDi>859911004MagLensMS</basicUdiDi>
    <tradeName>Magnification Lens</tradeName>
    <deviceName>Magnification Lens</deviceName>
    <manufacturerName>Bionix LLC</manufacturerName>
    <manufacturerSrn>US-MF-000020408</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12149080</emdnCode>
    <emdnDescription>VARIOUS ENT INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2265</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-03T14:00:58.487Z</lastUpdated>
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    <udiDi>00859911004740</udiDi>
    <basicUdiDi>859911004LightSourceNV</basicUdiDi>
    <tradeName>Light Source</tradeName>
    <deviceName>Light Source</deviceName>
    <manufacturerName>Bionix LLC</manufacturerName>
    <manufacturerSrn>US-MF-000020408</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z129004</emdnCode>
    <emdnDescription>LIGHT SOURCES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2200</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-03T14:00:57.694Z</lastUpdated>
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    <udiDi>00859911004702</udiDi>
    <basicUdiDi>859911004LightedForcep87</basicUdiDi>
    <tradeName>Lighted Forceps</tradeName>
    <deviceName>Lighted Forceps</deviceName>
    <manufacturerName>Bionix LLC</manufacturerName>
    <manufacturerSrn>US-MF-000020408</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q0399</emdnCode>
    <emdnDescription>ENT DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2750</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-03T14:00:53.681Z</lastUpdated>
  </row>
  <row>
    <udiDi>00859911004429</udiDi>
    <basicUdiDi>859911004SafeCurettesZF</basicUdiDi>
    <tradeName>Safe Ear Curettes</tradeName>
    <deviceName>Safe Ear Curette</deviceName>
    <manufacturerName>Bionix LLC</manufacturerName>
    <manufacturerSrn>US-MF-000020408</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q0399</emdnCode>
    <emdnDescription>ENT DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1222</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-03T14:00:52.887Z</lastUpdated>
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  <row>
    <udiDi>00859911004221</udiDi>
    <basicUdiDi>859911004DeCloggerYM</basicUdiDi>
    <tradeName>DeClogger</tradeName>
    <deviceName>DeClogger</deviceName>
    <manufacturerName>Bionix LLC</manufacturerName>
    <manufacturerSrn>US-MF-000020408</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>V9099</emdnCode>
    <emdnDescription>VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>911</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-03T14:00:52.087Z</lastUpdated>
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  <row>
    <udiDi>00859911004191</udiDi>
    <basicUdiDi>859911004SpeculumYH</basicUdiDi>
    <tradeName>Disposable Nasal Speculum</tradeName>
    <deviceName>Disposable Nasal Speculum</deviceName>
    <manufacturerName>Bionix LLC</manufacturerName>
    <manufacturerSrn>US-MF-000020408</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q030199</emdnCode>
    <emdnDescription>NASOPHARYNGEAL DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9877</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-03T14:00:51.282Z</lastUpdated>
  </row>
  <row>
    <udiDi>00859911004030</udiDi>
    <basicUdiDi>859911004OtoClearNE</basicUdiDi>
    <tradeName>OtoClear Ear Irrigation BHH</tradeName>
    <deviceName>OtoClear</deviceName>
    <manufacturerName>Bionix LLC</manufacturerName>
    <manufacturerSrn>US-MF-000020408</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12149099</emdnCode>
    <emdnDescription>VARIOUS ENT INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>701</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-03T14:00:47.277Z</lastUpdated>
  </row>
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    <udiDi>00714646000873</udiDi>
    <basicUdiDi>859911004LightedCuretteKH</basicUdiDi>
    <tradeName>Lighted Ear Curette</tradeName>
    <deviceName>Lighted Curettes</deviceName>
    <manufacturerName>Bionix LLC</manufacturerName>
    <manufacturerSrn>US-MF-000020408</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q0399</emdnCode>
    <emdnDescription>ENT DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3340</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-03T14:00:40.080Z</lastUpdated>
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    <udiDi>00714646001580</udiDi>
    <basicUdiDi>859911004LightedCuretteKH</basicUdiDi>
    <tradeName>Lighted Ear Curette</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Bionix LLC</manufacturerName>
    <manufacturerSrn>US-MF-000020408</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q0399</emdnCode>
    <emdnDescription>ENT DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3345</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-23T19:31:48.172Z</lastUpdated>
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    <udiDi>00714646001528</udiDi>
    <basicUdiDi>859911004LightedCuretteKH</basicUdiDi>
    <tradeName>Lighted Ear Curette</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Bionix LLC</manufacturerName>
    <manufacturerSrn>US-MF-000020408</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q0399</emdnCode>
    <emdnDescription>ENT DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2512</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-23T19:31:48.109Z</lastUpdated>
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    <udiDi>00714646001313</udiDi>
    <basicUdiDi>859911004LightedCuretteKH</basicUdiDi>
    <tradeName>Lighted Ear Curette</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Bionix LLC</manufacturerName>
    <manufacturerSrn>US-MF-000020408</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q0399</emdnCode>
    <emdnDescription>ENT DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3420</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-23T19:31:48.066Z</lastUpdated>
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    <udiDi>00714646001351</udiDi>
    <basicUdiDi>859911004LightedCuretteKH</basicUdiDi>
    <tradeName>Lighted Ear Curette</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Bionix LLC</manufacturerName>
    <manufacturerSrn>US-MF-000020408</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q0399</emdnCode>
    <emdnDescription>ENT DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3460</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-23T19:31:48.045Z</lastUpdated>
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    <udiDi>00714646001320</udiDi>
    <basicUdiDi>859911004LightedCuretteKH</basicUdiDi>
    <tradeName>Lighted Ear Curette</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Bionix LLC</manufacturerName>
    <manufacturerSrn>US-MF-000020408</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q0399</emdnCode>
    <emdnDescription>ENT DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3430</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-23T19:31:48.024Z</lastUpdated>
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    <udiDi>00714646001597</udiDi>
    <basicUdiDi>859911004LightedCuretteKH</basicUdiDi>
    <tradeName>Lighted Ear Curette</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Bionix LLC</manufacturerName>
    <manufacturerSrn>US-MF-000020408</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q0399</emdnCode>
    <emdnDescription>ENT DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3350</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-23T19:31:47.725Z</lastUpdated>
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    <udiDi>00714646001337</udiDi>
    <basicUdiDi>859911004LightedCuretteKH</basicUdiDi>
    <tradeName>Lighted Ear Curette</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Bionix LLC</manufacturerName>
    <manufacturerSrn>US-MF-000020408</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q0399</emdnCode>
    <emdnDescription>ENT DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3440</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-23T19:31:47.621Z</lastUpdated>
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    <udiDi>00714646001603</udiDi>
    <basicUdiDi>859911004LightedCuretteKH</basicUdiDi>
    <tradeName>Lighted Ear Curette</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Bionix LLC</manufacturerName>
    <manufacturerSrn>US-MF-000020408</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
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    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q0399</emdnCode>
    <emdnDescription>ENT DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3445</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-23T19:31:47.525Z</lastUpdated>
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    <udiDi>00714646001306</udiDi>
    <basicUdiDi>859911004LightedCuretteKH</basicUdiDi>
    <tradeName>Lighted Ear Curette</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Bionix LLC</manufacturerName>
    <manufacturerSrn>US-MF-000020408</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q0399</emdnCode>
    <emdnDescription>ENT DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3410</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-23T19:31:47.487Z</lastUpdated>
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    <udiDi>00714646001610</udiDi>
    <basicUdiDi>859911004LightedCuretteKH</basicUdiDi>
    <tradeName>Lighted Ear Curette</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Bionix LLC</manufacturerName>
    <manufacturerSrn>US-MF-000020408</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
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    <emdnCode>Q0399</emdnCode>
    <emdnDescription>ENT DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3450</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-23T19:31:47.413Z</lastUpdated>
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    <udiDi>00859911004153</udiDi>
    <basicUdiDi>859911004OtoClearNE</basicUdiDi>
    <tradeName>OtoClear SprayWash</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Bionix LLC</manufacturerName>
    <manufacturerSrn>US-MF-000020408</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12149099</emdnCode>
    <emdnDescription>VARIOUS ENT INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>7290</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T20:16:58.628Z</lastUpdated>
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