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<eudamedExport entity="devices">
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    <udiDi>00810178550104</udiDi>
    <basicUdiDi>81017855DNTSURGICALCW</basicUdiDi>
    <tradeName>Prima DNT Wall Mount</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Labo America Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000044352</manufacturerSrn>
    <authorisedRepresentativeName>Labomed Europe b.v.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000022889</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12011101</emdnCode>
    <emdnDescription>OPERATIVE MICROSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6137101</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-08T06:50:07.886Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810178550111</udiDi>
    <basicUdiDi>81017855DNTSURGICALCW</basicUdiDi>
    <tradeName>PRIMA DNT -Ceiling Mount</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Labo America Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000044352</manufacturerSrn>
    <authorisedRepresentativeName>Labomed Europe b.v.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000022889</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12011101</emdnCode>
    <emdnDescription>OPERATIVE MICROSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6137201</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-08T06:50:07.854Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810178550128</udiDi>
    <basicUdiDi>81017855DNTSURGICALCW</basicUdiDi>
    <tradeName>PRIMA DNT Trainer</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Labo America Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000044352</manufacturerSrn>
    <authorisedRepresentativeName>Labomed Europe b.v.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000022889</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12011101</emdnCode>
    <emdnDescription>OPERATIVE MICROSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6167500</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-08T06:50:07.832Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810178550135</udiDi>
    <basicUdiDi>81017855DNTSURGICALCW</basicUdiDi>
    <tradeName>PRIMA Mu DNT</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Labo America Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000044352</manufacturerSrn>
    <authorisedRepresentativeName>Labomed Europe b.v.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000022889</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12011101</emdnCode>
    <emdnDescription>OPERATIVE MICROSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6211000</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-08T06:50:07.804Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810178550166</udiDi>
    <basicUdiDi>81017855OPHSURGICALGR</basicUdiDi>
    <tradeName>PRIMA OPH -Cataract Microscope (XYZ)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Labo America Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000044352</manufacturerSrn>
    <authorisedRepresentativeName>Labomed Europe b.v.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000022889</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12011101</emdnCode>
    <emdnDescription>OPERATIVE MICROSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6135000</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-08T06:50:07.745Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810178550173</udiDi>
    <basicUdiDi>81017855OPHSURGICALGR</basicUdiDi>
    <tradeName>PRIMA OPH -Cataract Microscope (Z-Axis)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Labo America Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000044352</manufacturerSrn>
    <authorisedRepresentativeName>Labomed Europe b.v.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000022889</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12011101</emdnCode>
    <emdnDescription>OPERATIVE MICROSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6136000</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-08T06:50:07.721Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810178550180</udiDi>
    <basicUdiDi>81017855OPHSURGICALGR</basicUdiDi>
    <tradeName>Stella Microscope Retina</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Labo America Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000044352</manufacturerSrn>
    <authorisedRepresentativeName>Labomed Europe b.v.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000022889</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12011101</emdnCode>
    <emdnDescription>OPERATIVE MICROSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6219100</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-08T06:50:07.695Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810178550197</udiDi>
    <basicUdiDi>81017855OPHSURGICALGR</basicUdiDi>
    <tradeName>Stella Microscope Cataract</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Labo America Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000044352</manufacturerSrn>
    <authorisedRepresentativeName>Labomed Europe b.v.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000022889</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12011101</emdnCode>
    <emdnDescription>OPERATIVE MICROSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6219103</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-08T06:50:07.671Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810178550203</udiDi>
    <basicUdiDi>81017855ENTSURGICALDV</basicUdiDi>
    <tradeName>PRIMA Swift -Floor Mount</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Labo America Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000044352</manufacturerSrn>
    <authorisedRepresentativeName>Labomed Europe b.v.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000022889</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12011101</emdnCode>
    <emdnDescription>OPERATIVE MICROSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6182501</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-08T06:50:07.655Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810178550210</udiDi>
    <basicUdiDi>81017855ENTSURGICALDV</basicUdiDi>
    <tradeName>PRIMA Swift - Wall Mount</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Labo America Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000044352</manufacturerSrn>
    <authorisedRepresentativeName>Labomed Europe b.v.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000022889</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12011101</emdnCode>
    <emdnDescription>OPERATIVE MICROSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6182502</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-08T06:50:07.638Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810178550227</udiDi>
    <basicUdiDi>81017855ENTSURGICALDV</basicUdiDi>
    <tradeName>PRIMA Swift -Ceiling Mount</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Labo America Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000044352</manufacturerSrn>
    <authorisedRepresentativeName>Labomed Europe b.v.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000022889</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12011101</emdnCode>
    <emdnDescription>OPERATIVE MICROSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6182503</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-08T06:50:07.619Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810178550234</udiDi>
    <basicUdiDi>81017855ENTSURGICALDV</basicUdiDi>
    <tradeName>PRIMA ENT</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Labo America Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000044352</manufacturerSrn>
    <authorisedRepresentativeName>Labomed Europe b.v.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000022889</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12011101</emdnCode>
    <emdnDescription>OPERATIVE MICROSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6137000</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-08T06:50:07.597Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810178550241</udiDi>
    <basicUdiDi>81017855ENTSURGICALDV</basicUdiDi>
    <tradeName>PRIMA ENT -Motorized Fine Focus</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Labo America Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000044352</manufacturerSrn>
    <authorisedRepresentativeName>Labomed Europe b.v.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000022889</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12011101</emdnCode>
    <emdnDescription>OPERATIVE MICROSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6137000-100</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-08T06:50:07.579Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810178550258</udiDi>
    <basicUdiDi>81017855ENTSURGICALDV</basicUdiDi>
    <tradeName>Stella Neuro</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Labo America Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000044352</manufacturerSrn>
    <authorisedRepresentativeName>Labomed Europe b.v.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000022889</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12011101</emdnCode>
    <emdnDescription>OPERATIVE MICROSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6219200</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-08T06:50:07.559Z</lastUpdated>
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  <row>
    <udiDi>00810178550272</udiDi>
    <basicUdiDi>81017855GNSURGICALFR</basicUdiDi>
    <tradeName>eVA 500 -45° Inclined Binocular</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Labo America Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000044352</manufacturerSrn>
    <authorisedRepresentativeName>Labomed Europe b.v.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000022889</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12011101</emdnCode>
    <emdnDescription>OPERATIVE MICROSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6169200</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-08T06:50:07.505Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810178550289</udiDi>
    <basicUdiDi>81017855GNSURGICALFR</basicUdiDi>
    <tradeName>PRIMA GN</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Labo America Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000044352</manufacturerSrn>
    <authorisedRepresentativeName>Labomed Europe b.v.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000022889</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12011101</emdnCode>
    <emdnDescription>OPERATIVE MICROSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6165000</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-08T06:50:07.481Z</lastUpdated>
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  <row>
    <udiDi>00810178550296</udiDi>
    <basicUdiDi>81017855GNSURGICALFR</basicUdiDi>
    <tradeName>PRIMA C</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Labo America Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000044352</manufacturerSrn>
    <authorisedRepresentativeName>Labomed Europe b.v.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000022889</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12011101</emdnCode>
    <emdnDescription>OPERATIVE MICROSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6128000</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-08T06:50:07.450Z</lastUpdated>
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  <row>
    <udiDi>00810178550302</udiDi>
    <basicUdiDi>81017855GNSURGICALFR</basicUdiDi>
    <tradeName>PRIMA CS</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Labo America Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000044352</manufacturerSrn>
    <authorisedRepresentativeName>Labomed Europe b.v.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000022889</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12011101</emdnCode>
    <emdnDescription>OPERATIVE MICROSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6128600</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-08T06:50:07.425Z</lastUpdated>
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  <row>
    <udiDi>00810178550470</udiDi>
    <basicUdiDi>81017855ENTSURGICALDV</basicUdiDi>
    <tradeName>Stella ENT Microscope</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Labo America Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000044352</manufacturerSrn>
    <authorisedRepresentativeName>Labomed Europe b.v.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000022889</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12011101</emdnCode>
    <emdnDescription>OPERATIVE MICROSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6219106</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-08T06:50:07.104Z</lastUpdated>
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  <row>
    <udiDi>00810178550630</udiDi>
    <basicUdiDi>81017855ACCESSORIESH8</basicUdiDi>
    <tradeName>Binocular head, 0° to 210° inclinable</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Labo America Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000044352</manufacturerSrn>
    <authorisedRepresentativeName>Labomed Europe b.v.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000022889</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12011101</emdnCode>
    <emdnDescription>OPERATIVE MICROSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6122015</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-08T06:50:06.851Z</lastUpdated>
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