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<eudamedExport entity="devices">
  <row>
    <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>
  <row>
    <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>
  </row>
  <row>
    <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>
  </row>
  <row>
    <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>
  </row>
  <row>
    <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>
  </row>
  <row>
    <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>
  </row>
  <row>
    <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>
  </row>
  <row>
    <udiDi>00810178551804</udiDi>
    <basicUdiDi>81017855ACCESSORIESH8</basicUdiDi>
    <tradeName>Camera Mount DSLR Canon/Nikon</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>6134131-106</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-08T06:49:26.873Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810178551811</udiDi>
    <basicUdiDi>81017855ACCESSORIESH8</basicUdiDi>
    <tradeName>Video Adapter Smart Phone</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>6134172</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-08T06:49:26.860Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810178551828</udiDi>
    <basicUdiDi>81017855ACCESSORIESH8</basicUdiDi>
    <tradeName>Labomed  10x Eyepiece Pair, FOV 18mm</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>6129011</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-08T06:49:26.840Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810178551835</udiDi>
    <basicUdiDi>81017855ACCESSORIESH8</basicUdiDi>
    <tradeName>Labomed  10x Eyepiece Pair, FOV 18mm</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>6128910</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-08T06:49:26.794Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810178551842</udiDi>
    <basicUdiDi>81017855ACCESSORIESH8</basicUdiDi>
    <tradeName>Eyepiece - WF 12.5x/18mm eyepieces with diopter lock, fixed eyeguard</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>6135012</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-08T06:49:26.764Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810178551859</udiDi>
    <basicUdiDi>81017855ACCESSORIESH8</basicUdiDi>
    <tradeName>Eyepiece - WF 20x/12mm</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>6129020</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-08T06:49:26.692Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945087500095</udiDi>
    <basicUdiDi>69450875SurgicalMicro3C</basicUdiDi>
    <tradeName>Ophthalmic Surgical Microscope</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shanghai Mediworks Precision Instruments Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000004251</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12011101</emdnCode>
    <emdnDescription>OPERATIVE MICROSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SM660</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T02:08:23.401Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945087500293</udiDi>
    <basicUdiDi>69450875SurgicalMicrosFH</basicUdiDi>
    <tradeName>Surgical Microscopes</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shanghai Mediworks Precision Instruments Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000004251</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12011101</emdnCode>
    <emdnDescription>OPERATIVE MICROSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SM625D</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T02:08:23.256Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945087500309</udiDi>
    <basicUdiDi>69450875SurgicalMicrosFH</basicUdiDi>
    <tradeName>Surgical Microscopes</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shanghai Mediworks Precision Instruments Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000004251</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12011101</emdnCode>
    <emdnDescription>OPERATIVE MICROSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SM628S</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T02:08:23.229Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945087500316</udiDi>
    <basicUdiDi>69450875SurgicalMicrosFH</basicUdiDi>
    <tradeName>Surgical Microscopes</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shanghai Mediworks Precision Instruments Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000004251</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12011101</emdnCode>
    <emdnDescription>OPERATIVE MICROSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SM623D</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T02:08:23.205Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945087500323</udiDi>
    <basicUdiDi>69450875SurgicalMicrosFH</basicUdiDi>
    <tradeName>Surgical Microscopes</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shanghai Mediworks Precision Instruments Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000004251</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12011101</emdnCode>
    <emdnDescription>OPERATIVE MICROSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SM629F</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T02:08:23.180Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945087500392</udiDi>
    <basicUdiDi>69450875SurgicalMicrosFH</basicUdiDi>
    <tradeName>Surgical Microscopes</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shanghai Mediworks Precision Instruments Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000004251</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12011101</emdnCode>
    <emdnDescription>OPERATIVE MICROSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SM626M</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T02:08:23.152Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945087500514</udiDi>
    <basicUdiDi>69450875SurgicalMicro3C</basicUdiDi>
    <tradeName>Ophthalmic Surgical Microscop</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shanghai Mediworks Precision Instruments Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000004251</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12011101</emdnCode>
    <emdnDescription>OPERATIVE MICROSCOPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SM660B</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T02:08:23.081Z</lastUpdated>
  </row>
</eudamedExport>