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    <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>
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    <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>
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    <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>
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    <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>
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    <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>
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    <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>
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    <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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    <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>
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    <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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    <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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    <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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    <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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  <row>
    <udiDi>00810178550647</udiDi>
    <basicUdiDi>81017855ACCESSORIESH8</basicUdiDi>
    <tradeName>Binocular head, 45° inclined</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>6121035</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-08T06:50:06.839Z</lastUpdated>
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    <udiDi>00810178550654</udiDi>
    <basicUdiDi>81017855ACCESSORIESH8</basicUdiDi>
    <tradeName>Binocular head, straight</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>6121025</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-08T06:50:06.826Z</lastUpdated>
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    <udiDi>00810178550661</udiDi>
    <basicUdiDi>81017855ACCESSORIESH8</basicUdiDi>
    <tradeName>Inclined double beam splitter 50:50</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>6134160</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-08T06:50:06.814Z</lastUpdated>
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    <udiDi>00810178550678</udiDi>
    <basicUdiDi>81017855ACCESSORIESH8</basicUdiDi>
    <tradeName>Adapter for C-mount Camera</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>6134110</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-08T06:50:06.799Z</lastUpdated>
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    <udiDi>00810178550685</udiDi>
    <basicUdiDi>81017855ACCESSORIESH8</basicUdiDi>
    <tradeName>Double beam splitter 50:50</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>6134150</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-08T06:50:06.785Z</lastUpdated>
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    <udiDi>00810178550692</udiDi>
    <basicUdiDi>81017855ACCESSORIESH8</basicUdiDi>
    <tradeName>Double beam splitter 80:20</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>6134152</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-08T06:50:06.769Z</lastUpdated>
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    <udiDi>00810178550708</udiDi>
    <basicUdiDi>81017855ACCESSORIESH8</basicUdiDi>
    <tradeName>Inclined double beam splitter 80:20</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>6134162</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-08T06:50:06.752Z</lastUpdated>
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