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<eudamedExport entity="devices">
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    <basicUdiDi>081737702101000064</basicUdiDi>
    <tradeName>TriplePlay</tradeName>
    <deviceName>TriplePlan Airflow</deviceName>
    <manufacturerName>Dymedix Diagnostics, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000015691</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12100585</emdnCode>
    <emdnDescription>POLYSOMNOGRAPHY INSTRUMENTS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>12-40321-0001</reference>
    <placedOnMarketCountry>Portugal</placedOnMarketCountry>
    <lastUpdated>2026-07-30T16:57:37.101Z</lastUpdated>
  </row>
  <row>
    <udiDi>00817377022623</udiDi>
    <basicUdiDi>0817377021813300AG</basicUdiDi>
    <tradeName>Snugglefit Effort Belt</tradeName>
    <deviceName>Snuggle Fit</deviceName>
    <manufacturerName>Dymedix Diagnostics, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000015691</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12100585</emdnCode>
    <emdnDescription>POLYSOMNOGRAPHY INSTRUMENTS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>18-01813-0001</reference>
    <placedOnMarketCountry>Portugal</placedOnMarketCountry>
    <lastUpdated>2026-07-30T16:57:36.303Z</lastUpdated>
  </row>
  <row>
    <udiDi>00817377022739</udiDi>
    <basicUdiDi>081737702101000064</basicUdiDi>
    <tradeName>TriplePlay</tradeName>
    <deviceName>TriplePlan Airflow</deviceName>
    <manufacturerName>Dymedix Diagnostics, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000015691</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12100585</emdnCode>
    <emdnDescription>POLYSOMNOGRAPHY INSTRUMENTS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>12-40320-0001</reference>
    <placedOnMarketCountry>Portugal</placedOnMarketCountry>
    <lastUpdated>2026-07-30T16:56:10.752Z</lastUpdated>
  </row>
  <row>
    <udiDi>00817377022616</udiDi>
    <basicUdiDi>0817377021813300AG</basicUdiDi>
    <tradeName>Snugglefit Effort Belt</tradeName>
    <deviceName>Snuggle Fit</deviceName>
    <manufacturerName>Dymedix Diagnostics, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000015691</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12100585</emdnCode>
    <emdnDescription>POLYSOMNOGRAPHY INSTRUMENTS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>18-01812-0001</reference>
    <placedOnMarketCountry>Portugal</placedOnMarketCountry>
    <lastUpdated>2026-07-30T16:56:09.960Z</lastUpdated>
  </row>
  <row>
    <udiDi>B140MBJR0</udiDi>
    <basicUdiDi>++B140MediByte4Q</basicUdiDi>
    <tradeName>MediByte Jr</tradeName>
    <deviceName>MediByte</deviceName>
    <manufacturerName>BRAEBON Medical Corporation</manufacturerName>
    <manufacturerSrn>CA-MF-000002190</manufacturerSrn>
    <authorisedRepresentativeName>AR Experts B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000023989</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12100501</emdnCode>
    <emdnDescription>POLYSOMNOGRAPHS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MBJR</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T15:17:35.508Z</lastUpdated>
  </row>
  <row>
    <udiDi>04038653346066</udiDi>
    <basicUdiDi>40392390000026783G</basicUdiDi>
    <tradeName>Aesculap</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Aesculap AG</manufacturerName>
    <manufacturerSrn>DE-MF-000005504</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12100980</emdnCode>
    <emdnDescription>INSTRUMENTS FOR MOTORISED NEUROSURGERY SYSTEMS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GC114R</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-30T11:49:12.062Z</lastUpdated>
  </row>
  <row>
    <udiDi>04038653346073</udiDi>
    <basicUdiDi>40392390000026783G</basicUdiDi>
    <tradeName>Aesculap</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Aesculap AG</manufacturerName>
    <manufacturerSrn>DE-MF-000005504</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12100980</emdnCode>
    <emdnDescription>INSTRUMENTS FOR MOTORISED NEUROSURGERY SYSTEMS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GC115R</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-30T11:49:12.038Z</lastUpdated>
  </row>
  <row>
    <udiDi>04038653346080</udiDi>
    <basicUdiDi>40392390000026783G</basicUdiDi>
    <tradeName>Aesculap</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Aesculap AG</manufacturerName>
    <manufacturerSrn>DE-MF-000005504</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12100980</emdnCode>
    <emdnDescription>INSTRUMENTS FOR MOTORISED NEUROSURGERY SYSTEMS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GC124R</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-30T11:49:11.999Z</lastUpdated>
  </row>
  <row>
    <udiDi>04038653346097</udiDi>
    <basicUdiDi>40392390000026783G</basicUdiDi>
    <tradeName>Aesculap</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Aesculap AG</manufacturerName>
    <manufacturerSrn>DE-MF-000005504</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12100980</emdnCode>
    <emdnDescription>INSTRUMENTS FOR MOTORISED NEUROSURGERY SYSTEMS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GC125R</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-30T11:49:11.968Z</lastUpdated>
  </row>
  <row>
    <udiDi>04038653346103</udiDi>
    <basicUdiDi>40392390000026783G</basicUdiDi>
    <tradeName>Aesculap</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Aesculap AG</manufacturerName>
    <manufacturerSrn>DE-MF-000005504</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12100980</emdnCode>
    <emdnDescription>INSTRUMENTS FOR MOTORISED NEUROSURGERY SYSTEMS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GC127R</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-30T11:49:11.947Z</lastUpdated>
  </row>
  <row>
    <udiDi>04038653346110</udiDi>
    <basicUdiDi>40392390000026783G</basicUdiDi>
    <tradeName>Aesculap</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Aesculap AG</manufacturerName>
    <manufacturerSrn>DE-MF-000005504</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12100980</emdnCode>
    <emdnDescription>INSTRUMENTS FOR MOTORISED NEUROSURGERY SYSTEMS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GC128R</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-30T11:49:11.933Z</lastUpdated>
  </row>
  <row>
    <udiDi>04038653346127</udiDi>
    <basicUdiDi>40392390000026783G</basicUdiDi>
    <tradeName>Aesculap</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Aesculap AG</manufacturerName>
    <manufacturerSrn>DE-MF-000005504</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12100980</emdnCode>
    <emdnDescription>INSTRUMENTS FOR MOTORISED NEUROSURGERY SYSTEMS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GC137R</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-30T11:49:11.918Z</lastUpdated>
  </row>
  <row>
    <udiDi>04038653346134</udiDi>
    <basicUdiDi>40392390000026783G</basicUdiDi>
    <tradeName>Aesculap</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Aesculap AG</manufacturerName>
    <manufacturerSrn>DE-MF-000005504</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12100980</emdnCode>
    <emdnDescription>INSTRUMENTS FOR MOTORISED NEUROSURGERY SYSTEMS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GC138R</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-30T11:49:11.883Z</lastUpdated>
  </row>
  <row>
    <udiDi>04038653346141</udiDi>
    <basicUdiDi>40392390000026783G</basicUdiDi>
    <tradeName>Aesculap</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Aesculap AG</manufacturerName>
    <manufacturerSrn>DE-MF-000005504</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12100980</emdnCode>
    <emdnDescription>INSTRUMENTS FOR MOTORISED NEUROSURGERY SYSTEMS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GC139R</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-30T11:49:11.852Z</lastUpdated>
  </row>
  <row>
    <udiDi>04038653346158</udiDi>
    <basicUdiDi>40392390000026783G</basicUdiDi>
    <tradeName>Aesculap</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Aesculap AG</manufacturerName>
    <manufacturerSrn>DE-MF-000005504</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12100980</emdnCode>
    <emdnDescription>INSTRUMENTS FOR MOTORISED NEUROSURGERY SYSTEMS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GC148R</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-30T11:49:11.813Z</lastUpdated>
  </row>
  <row>
    <udiDi>04038653346165</udiDi>
    <basicUdiDi>40392390000026783G</basicUdiDi>
    <tradeName>Aesculap</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Aesculap AG</manufacturerName>
    <manufacturerSrn>DE-MF-000005504</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12100980</emdnCode>
    <emdnDescription>INSTRUMENTS FOR MOTORISED NEUROSURGERY SYSTEMS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GC149R</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-30T11:49:11.786Z</lastUpdated>
  </row>
  <row>
    <udiDi>04038653378692</udiDi>
    <basicUdiDi>403923900000267132</basicUdiDi>
    <tradeName>HI-LINE XS</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Aesculap AG</manufacturerName>
    <manufacturerSrn>DE-MF-000005504</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12100980</emdnCode>
    <emdnDescription>INSTRUMENTS FOR MOTORISED NEUROSURGERY SYSTEMS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GE401R</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-30T11:49:08.098Z</lastUpdated>
  </row>
  <row>
    <udiDi>04038653378708</udiDi>
    <basicUdiDi>403923900000267132</basicUdiDi>
    <tradeName>HI-LINE XS</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Aesculap AG</manufacturerName>
    <manufacturerSrn>DE-MF-000005504</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12100980</emdnCode>
    <emdnDescription>INSTRUMENTS FOR MOTORISED NEUROSURGERY SYSTEMS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GE402R</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-30T11:49:08.078Z</lastUpdated>
  </row>
  <row>
    <udiDi>04038653378715</udiDi>
    <basicUdiDi>403923900000267132</basicUdiDi>
    <tradeName>HI-LINE XS</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Aesculap AG</manufacturerName>
    <manufacturerSrn>DE-MF-000005504</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12100980</emdnCode>
    <emdnDescription>INSTRUMENTS FOR MOTORISED NEUROSURGERY SYSTEMS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GE403R</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-30T11:49:08.049Z</lastUpdated>
  </row>
  <row>
    <udiDi>04038653378722</udiDi>
    <basicUdiDi>403923900000267132</basicUdiDi>
    <tradeName>HI-LINE XS</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Aesculap AG</manufacturerName>
    <manufacturerSrn>DE-MF-000005504</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12100980</emdnCode>
    <emdnDescription>INSTRUMENTS FOR MOTORISED NEUROSURGERY SYSTEMS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GE404R</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-30T11:49:08.029Z</lastUpdated>
  </row>
</eudamedExport>