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    <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>
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    <lastUpdated>2026-06-06T10:59:41.852Z</lastUpdated>
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    <udiDi>00810178551644</udiDi>
    <basicUdiDi>81017855DNTSURGICALCW</basicUdiDi>
    <tradeName>Labomed Prima DNT</tradeName>
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    <manufacturerName>Labo America Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000044352</manufacturerSrn>
    <authorisedRepresentativeName>Labomed Europe b.v.</authorisedRepresentativeName>
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    <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>
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    <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>
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    <deviceStatus>Piyasada</deviceStatus>
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    <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>MDR 2017/745</legislation>
    <emdnCode>Z12011101</emdnCode>
    <emdnDescription>OPERATIVE MICROSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <lastUpdated>2026-06-06T10:59:37.434Z</lastUpdated>
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    <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>MDR 2017/745</legislation>
    <emdnCode>Z12011101</emdnCode>
    <emdnDescription>OPERATIVE MICROSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <lastUpdated>2026-06-06T10:59:36.340Z</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>MDR 2017/745</legislation>
    <emdnCode>Z12011101</emdnCode>
    <emdnDescription>OPERATIVE MICROSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <lastUpdated>2026-06-06T10:59:35.238Z</lastUpdated>
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    <udiDi>00810178551576</udiDi>
    <basicUdiDi>81017855ACCESSORIESH8</basicUdiDi>
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    <deviceName></deviceName>
    <manufacturerName>Labo America Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000044352</manufacturerSrn>
    <authorisedRepresentativeName>Labomed Europe b.v.</authorisedRepresentativeName>
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    <emdnDescription>OPERATIVE MICROSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <lastUpdated>2026-06-06T10:59:34.141Z</lastUpdated>
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    <udiDi>00810178551569</udiDi>
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    <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>MDR 2017/745</legislation>
    <emdnCode>Z12011101</emdnCode>
    <emdnDescription>OPERATIVE MICROSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-06T10:59:33.037Z</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>MDR 2017/745</legislation>
    <emdnCode>Z12011101</emdnCode>
    <emdnDescription>OPERATIVE MICROSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-06T10:59:31.943Z</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>
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    <emdnCode>Z12011101</emdnCode>
    <emdnDescription>OPERATIVE MICROSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-06T10:59:30.857Z</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>MDR 2017/745</legislation>
    <emdnCode>Z12011101</emdnCode>
    <emdnDescription>OPERATIVE MICROSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference></reference>
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    <lastUpdated>2026-06-06T10:59:29.751Z</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>MDR 2017/745</legislation>
    <emdnCode>Z12011101</emdnCode>
    <emdnDescription>OPERATIVE MICROSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-06T10:59:28.664Z</lastUpdated>
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    <udiDi>00810178551514</udiDi>
    <basicUdiDi>81017855ACCESSORIESH8</basicUdiDi>
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    <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>
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    <emdnCode>Z12011101</emdnCode>
    <emdnDescription>OPERATIVE MICROSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-06T10:59:27.581Z</lastUpdated>
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    <udiDi>00810178551507</udiDi>
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    <tradeName>00810178551507</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Labo America Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000044352</manufacturerSrn>
    <authorisedRepresentativeName>Labomed Europe b.v.</authorisedRepresentativeName>
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    <emdnDescription>OPERATIVE MICROSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference></reference>
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    <lastUpdated>2026-06-06T10:59:26.495Z</lastUpdated>
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    <udiDi>00810178551491</udiDi>
    <basicUdiDi>81017855ACCESSORIESH8</basicUdiDi>
    <tradeName>Sterlizable Knob Cover Filter Slider Knob</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Labo America Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000044352</manufacturerSrn>
    <authorisedRepresentativeName>Labomed Europe b.v.</authorisedRepresentativeName>
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    <lastUpdated>2026-06-06T10:59:25.402Z</lastUpdated>
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    <udiDi>00810178551484</udiDi>
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    <tradeName>Sterlizable Knob Cover ENT T-Handle</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Labo America Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000044352</manufacturerSrn>
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    <udiDi>00810178551477</udiDi>
    <basicUdiDi>81017855ACCESSORIESH8</basicUdiDi>
    <tradeName>Sterlizable Knob Cover Double Iris</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Labo America Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000044352</manufacturerSrn>
    <authorisedRepresentativeName>Labomed Europe b.v.</authorisedRepresentativeName>
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    <tradeName>Sterlizable Knob Cover (Magna Right Side Handle)</tradeName>
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    <manufacturerName>Labo America Inc.</manufacturerName>
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    <tradeName>Sterlizbale  Knob Cover (Magna ABA Left Hand Magnetic Button)</tradeName>
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    <manufacturerName>Labo America Inc.</manufacturerName>
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