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    <basicUdiDi>81017855ACCESSORIESH8</basicUdiDi>
    <tradeName>00810178551514</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>6137500-800</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-08T06:49:27.455Z</lastUpdated>
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    <udiDi>00810178551521</udiDi>
    <basicUdiDi>81017855ACCESSORIESH8</basicUdiDi>
    <tradeName>Pico Conversion Kit-Standard Arm</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>6137600</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-08T06:49:27.428Z</lastUpdated>
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    <udiDi>00810178551538</udiDi>
    <basicUdiDi>81017855ACCESSORIESH8</basicUdiDi>
    <tradeName>Pico Conversion Kit (Long Arm)</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>6137650</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-08T06:49:27.393Z</lastUpdated>
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    <udiDi>00810178551545</udiDi>
    <basicUdiDi>81017855ACCESSORIESH8</basicUdiDi>
    <tradeName>Double iris diaphram kit</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>6214051</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-08T06:49:27.373Z</lastUpdated>
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    <udiDi>00810178551552</udiDi>
    <basicUdiDi>81017855ACCESSORIESH8</basicUdiDi>
    <tradeName>00810178551552</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>6168500-830</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-08T06:49:27.354Z</lastUpdated>
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    <udiDi>00810178551569</udiDi>
    <basicUdiDi>81017855ACCESSORIESH8</basicUdiDi>
    <tradeName>00810178551569</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>6165000-946</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-08T06:49:27.331Z</lastUpdated>
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    <udiDi>00810178551576</udiDi>
    <basicUdiDi>81017855ACCESSORIESH8</basicUdiDi>
    <tradeName>00810178551576</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>6165000-840</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-08T06:49:27.312Z</lastUpdated>
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    <udiDi>00810178551583</udiDi>
    <basicUdiDi>81017855ACCESSORIESH8</basicUdiDi>
    <tradeName>Sterlizable knob cover kit</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>6168000-221</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-08T06:49:27.288Z</lastUpdated>
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  <row>
    <udiDi>00810178551606</udiDi>
    <basicUdiDi>81017855ENTSURGICALDV</basicUdiDi>
    <tradeName>PRIMA lite ENT -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>6182504</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-08T06:49:27.260Z</lastUpdated>
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  <row>
    <udiDi>00810178551613</udiDi>
    <basicUdiDi>81017855ENTSURGICALDV</basicUdiDi>
    <tradeName>PRIMA lite ENT -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>6182505</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-08T06:49:27.231Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810178551620</udiDi>
    <basicUdiDi>81017855ENTSURGICALDV</basicUdiDi>
    <tradeName>PRIMA lite ENT-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>6182506</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-08T06:49:27.198Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810178551637</udiDi>
    <basicUdiDi>81017855ENTSURGICALDV</basicUdiDi>
    <tradeName>PRIMA lite ENT-Extension Arm</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>6182511</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-08T06:49:27.157Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810178551644</udiDi>
    <basicUdiDi>81017855DNTSURGICALCW</basicUdiDi>
    <tradeName>Labomed Prima 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>6138000-100</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-08T06:49:27.125Z</lastUpdated>
  </row>
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    <udiDi>00810178551651</udiDi>
    <basicUdiDi>81017855ENTSURGICALDV</basicUdiDi>
    <tradeName>PRIMA  Mu 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>6137010</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-08T06:49:27.090Z</lastUpdated>
  </row>
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    <udiDi>00810178551668</udiDi>
    <basicUdiDi>81017855GNSURGICALFR</basicUdiDi>
    <tradeName>PRIMA  C plus</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>Prima C plus (6128900)</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-08T06:49:27.061Z</lastUpdated>
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    <udiDi>00810178551699</udiDi>
    <basicUdiDi>81017855GNSURGICALFR</basicUdiDi>
    <tradeName>PRIMA Swift OTS</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>6182514</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-08T06:49:27.024Z</lastUpdated>
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    <udiDi>00810178551743</udiDi>
    <basicUdiDi>81017855ACCESSORIESH8</basicUdiDi>
    <tradeName>Single Beam Splitter,up/down,4k,flat,C-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>6122504</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-08T06:49:26.999Z</lastUpdated>
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    <udiDi>00810178551750</udiDi>
    <basicUdiDi>81017855ACCESSORIESH8</basicUdiDi>
    <tradeName>Single Beam Splitter,left/right,4k,C-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>6122503</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-08T06:49:26.970Z</lastUpdated>
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    <udiDi>00810178551781</udiDi>
    <basicUdiDi>81017855ACCESSORIESH8</basicUdiDi>
    <tradeName>CMO 175mm Prima OPH</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>6133176</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-08T06:49:26.920Z</lastUpdated>
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    <udiDi>00810178551798</udiDi>
    <basicUdiDi>81017855ACCESSORIESH8</basicUdiDi>
    <tradeName>Univeral Mobile Adapter</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>6134174</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-08T06:49:26.894Z</lastUpdated>
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