<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>00814088020047</udiDi>
    <basicUdiDi>081408802AC-1001000JP</basicUdiDi>
    <tradeName>ivWatch Fiber Optic Sensor Cable</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ivWatch, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000001531</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AC-1001000</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T20:37:52.681Z</lastUpdated>
  </row>
  <row>
    <udiDi>00814088020108</udiDi>
    <basicUdiDi>081408802AC-1002000JW</basicUdiDi>
    <tradeName>ivWatch SmartTouch Sensor</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ivWatch, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000001531</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AC-1002000</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T20:37:52.667Z</lastUpdated>
  </row>
  <row>
    <udiDi>00814088020115</udiDi>
    <basicUdiDi>081408802AC-1001002JT</basicUdiDi>
    <tradeName>ivWatch Patient Cable</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ivWatch, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000001531</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AC-1001002</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T20:37:52.657Z</lastUpdated>
  </row>
  <row>
    <udiDi>00814088020122</udiDi>
    <basicUdiDi>081408802AE-1001003LB</basicUdiDi>
    <tradeName>ivWatch Extension Module</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ivWatch, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000001531</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>GENERAL MEDICINE DIAGNOSIS AND MONITORING INSTRUMENTS - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AE-1001003</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T20:37:52.640Z</lastUpdated>
  </row>
  <row>
    <udiDi>00814088020146</udiDi>
    <basicUdiDi>081408802AE-1001027LR</basicUdiDi>
    <tradeName>ivWatch Patient Monitor</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ivWatch, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000001531</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>GENERAL MEDICINE DIAGNOSIS AND MONITORING INSTRUMENTS - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AE-1001022</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T20:37:52.612Z</lastUpdated>
  </row>
  <row>
    <udiDi>00814088020351</udiDi>
    <basicUdiDi>081408802AE-1001027LR</basicUdiDi>
    <tradeName>ivWatch Patient Monitor</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ivWatch, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000001531</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>GENERAL MEDICINE DIAGNOSIS AND MONITORING INSTRUMENTS - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AE-1001027</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T20:37:52.585Z</lastUpdated>
  </row>
  <row>
    <udiDi>00814088020863</udiDi>
    <basicUdiDi>081408802AM-1002074SZ</basicUdiDi>
    <tradeName>ivWatch Sensor Receptacle</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ivWatch, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000001531</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AM-1002074</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T20:37:52.562Z</lastUpdated>
  </row>
</eudamedExport>