<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>10857156006205</udiDi>
    <basicUdiDi>B-10857156006205</basicUdiDi>
    <tradeName>Tenex Health TX System</tradeName>
    <deviceName>TX1 Procedure Pack</deviceName>
    <manufacturerName>Tenex Health, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000034123</manufacturerSrn>
    <authorisedRepresentativeName>Donawa Lifescience Consulting Srl</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000007785</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12010885</emdnCode>
    <emdnDescription>INSTRUMENTS FOR ULTRASONIC SURGERY - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>554-1003-002</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-22T19:50:01.479Z</lastUpdated>
  </row>
  <row>
    <udiDi>00857156006307</udiDi>
    <basicUdiDi>B-00857156006307</basicUdiDi>
    <tradeName>Tenex Health TX System</tradeName>
    <deviceName>Tenex Health TX System Console</deviceName>
    <manufacturerName>Tenex Health, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000034123</manufacturerSrn>
    <authorisedRepresentativeName>Donawa Lifescience Consulting Srl</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000007785</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12010880</emdnCode>
    <emdnDescription>INSTRUMENTS FOR ULTRASONIC SURGERY - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>554-0000-000</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-22T19:48:16.587Z</lastUpdated>
  </row>
</eudamedExport>