<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>00850064210002</udiDi>
    <basicUdiDi>08500642100JG</basicUdiDi>
    <tradeName>ANNE Chest Sensor</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Sibel Health Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000037280</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>MULTI-PARAMETER MONITORS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>900-00007</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T22:43:53.549Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850064210057</udiDi>
    <basicUdiDi>08500642100JG</basicUdiDi>
    <tradeName>ANNE One System Bedside Charger</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Sibel Health Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000037280</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>MULTI-PARAMETER MONITORS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>900-00008</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T22:43:53.531Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850064210088</udiDi>
    <basicUdiDi>08500642100JG</basicUdiDi>
    <tradeName>ANNE Limb Sensor</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Sibel Health Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000037280</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>MULTI-PARAMETER MONITORS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>900-00003</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T22:43:53.510Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850064210132</udiDi>
    <basicUdiDi>08500642100JG</basicUdiDi>
    <tradeName>ANNE View</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Sibel Health Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000037280</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>MULTI-PARAMETER MONITORS - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>900-00012</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T22:43:53.487Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850064210163</udiDi>
    <basicUdiDi>08500642100JG</basicUdiDi>
    <tradeName>Central Hub</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Sibel Health Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000037280</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>MULTI-PARAMETER MONITORS - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>900-00013</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T22:43:53.463Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850064210170</udiDi>
    <basicUdiDi>08500642100JG</basicUdiDi>
    <tradeName>Anne Chest Adhesive, Standard Wear</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Sibel Health Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000037280</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>MULTI-PARAMETER MONITORS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>900-00037</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T22:43:53.440Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850064210293</udiDi>
    <basicUdiDi>08500642100JG</basicUdiDi>
    <tradeName>ANNE Limb Adhesive</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Sibel Health Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000037280</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>MULTI-PARAMETER MONITORS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>900-00071</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T22:43:53.419Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850064210309</udiDi>
    <basicUdiDi>08500642100JG</basicUdiDi>
    <tradeName>Anne Chest Adhesive, Gentle Wear</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Sibel Health Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000037280</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>MULTI-PARAMETER MONITORS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>900-00072</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T22:43:53.399Z</lastUpdated>
  </row>
  <row>
    <udiDi>00860004541738</udiDi>
    <basicUdiDi>08500642100JG</basicUdiDi>
    <tradeName>ANNE One System</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Sibel Health Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000037280</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>MULTI–PARAMETER MONITORS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SA-004-01</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T20:16:55.077Z</lastUpdated>
  </row>
  <row>
    <udiDi>00860004541776</udiDi>
    <basicUdiDi>08600045417SA-020DX</basicUdiDi>
    <tradeName>ADAM</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Sibel Health Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000037280</manufacturerSrn>
    <authorisedRepresentativeName>Lorit Consultancy GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>AT-AR-000035932</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SA-020</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T20:16:55.056Z</lastUpdated>
  </row>
</eudamedExport>