<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>04250413406876</udiDi>
    <basicUdiDi>42504134SleepAdagioDD</basicUdiDi>
    <tradeName>Sleep Adagio Pro without PLM</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SOMNOmedics AG</manufacturerName>
    <manufacturerSrn>DE-PR-000042026</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12100501</emdnCode>
    <emdnDescription>POLYSOMNOGRAPHS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SAD150</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-30T21:36:23.585Z</lastUpdated>
  </row>
  <row>
    <udiDi>04250413406869</udiDi>
    <basicUdiDi>42504134SOMNOHDND</basicUdiDi>
    <tradeName>SOMNO HD RC Tele</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SOMNOmedics AG</manufacturerName>
    <manufacturerSrn>DE-PR-000042026</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12100501</emdnCode>
    <emdnDescription>POLYSOMNOGRAPHS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NGD150A</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-30T21:36:19.587Z</lastUpdated>
  </row>
  <row>
    <udiDi>04250413406463</udiDi>
    <basicUdiDi>42504134ABPM-ManCX</basicUdiDi>
    <tradeName>Cuff ABPMpro for right arm</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SOMNOmedics AG</manufacturerName>
    <manufacturerSrn>DE-MF-000006921</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12100380</emdnCode>
    <emdnDescription>ELECTROENCEPHALOGRAPHY INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ABP501R</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T21:36:17.980Z</lastUpdated>
  </row>
  <row>
    <udiDi>04250413406333</udiDi>
    <basicUdiDi>42504134iEGurtWD</basicUdiDi>
    <tradeName>Inductive Effort Belt - Size M</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SOMNOmedics AG</manufacturerName>
    <manufacturerSrn>DE-MF-000006921</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12100580</emdnCode>
    <emdnDescription>POLYSOMNOGRAPHY INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SEN661/1</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T21:36:12.355Z</lastUpdated>
  </row>
  <row>
    <udiDi>04250413406296</udiDi>
    <basicUdiDi>42504134Adapter8Q</basicUdiDi>
    <tradeName>Right-angled adapter</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SOMNOmedics AG</manufacturerName>
    <manufacturerSrn>DE-MF-000006921</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12100580</emdnCode>
    <emdnDescription>POLYSOMNOGRAPHY INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SEN213</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T21:36:10.754Z</lastUpdated>
  </row>
  <row>
    <udiDi>04250413405633</udiDi>
    <basicUdiDi>42504134EEG-S6L</basicUdiDi>
    <tradeName>EEG-sensor</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SOMNOmedics AG</manufacturerName>
    <manufacturerSrn>DE-MF-000006921</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12100380</emdnCode>
    <emdnDescription>ELECTROENCEPHALOGRAPHY INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SEW141</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T21:35:59.655Z</lastUpdated>
  </row>
  <row>
    <udiDi>04250413405015</udiDi>
    <basicUdiDi>42504134SOMNOtouchNIBPXX</basicUdiDi>
    <tradeName>Add-on device: SOMNOtouch NIBP</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SOMNOmedics AG</manufacturerName>
    <manufacturerSrn>DE-PR-000042026</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12100501</emdnCode>
    <emdnDescription>POLYSOMNOGRAPHS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TON100A</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-30T21:35:56.357Z</lastUpdated>
  </row>
  <row>
    <udiDi>04250413404971</udiDi>
    <basicUdiDi>42504134PSGSC</basicUdiDi>
    <tradeName>SOMNOtouch™ RESP eco anniversary edition</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SOMNOmedics AG</manufacturerName>
    <manufacturerSrn>DE-MF-000006921</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12100501</emdnCode>
    <emdnDescription>POLYSOMNOGRAPHS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TOR050-E-D</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T21:35:52.362Z</lastUpdated>
  </row>
  <row>
    <udiDi>04250413404872</udiDi>
    <basicUdiDi>42504134SOMNOtouchRESPZS</basicUdiDi>
    <tradeName>SOMNOtouch PSG online (AASM) and PTZ Camera</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SOMNOmedics AG</manufacturerName>
    <manufacturerSrn>DE-PR-000042026</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12100501</emdnCode>
    <emdnDescription>POLYSOMNOGRAPHS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TOR210</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-30T21:35:50.755Z</lastUpdated>
  </row>
  <row>
    <udiDi>04250435526996</udiDi>
    <basicUdiDi>42504355PA09EZ</basicUdiDi>
    <tradeName>DORO® Lubricant HP500</tradeName>
    <deviceName>Oil</deviceName>
    <manufacturerName>Black Forest Medical GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005752</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12109080</emdnCode>
    <emdnDescription>VARIOUS NEUROLOGY AND NEUROSURGERY INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1001.999</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T21:33:34.944Z</lastUpdated>
  </row>
  <row>
    <udiDi>04250435517789</udiDi>
    <basicUdiDi>42504355PA0601YS</basicUdiDi>
    <tradeName>DORO LUCENT® Sterile Disposable Skull Pins, Adult (3 pcs)</tradeName>
    <deviceName>Sterile Disposable Skull Pin</deviceName>
    <manufacturerName>Black Forest Medical GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005752</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12109080</emdnCode>
    <emdnDescription>VARIOUS NEUROLOGY AND NEUROSURGERY INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1106.003</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T21:33:34.135Z</lastUpdated>
  </row>
  <row>
    <udiDi>04250435516232</udiDi>
    <basicUdiDi>42504355PA05ER</basicUdiDi>
    <tradeName>DORO® Skull Clamp Radiolucent for DORO LUCENT® Parallelogram Adaptor (1 pcs)</tradeName>
    <deviceName>Headrestsystem for MR imaging</deviceName>
    <manufacturerName>Black Forest Medical GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005752</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12109080</emdnCode>
    <emdnDescription>VARIOUS NEUROLOGY AND NEUROSURGERY INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>4003.001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T21:33:33.348Z</lastUpdated>
  </row>
  <row>
    <udiDi>04250435501047</udiDi>
    <basicUdiDi>42504355PA0602YU</basicUdiDi>
    <tradeName>DORO® Reusable Skull Pins Stainless Steel, Pediatric (3 pcs)</tradeName>
    <deviceName>Reusable Skull Pin</deviceName>
    <manufacturerName>Black Forest Medical GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005752</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12109080</emdnCode>
    <emdnDescription>VARIOUS NEUROLOGY AND NEUROSURGERY INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3004-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T21:33:00.631Z</lastUpdated>
  </row>
  <row>
    <udiDi>04250435500019</udiDi>
    <basicUdiDi>42504355PA02EK</basicUdiDi>
    <tradeName>DORO®  Adjustable Base Unit</tradeName>
    <deviceName>Headrestsystem metal</deviceName>
    <manufacturerName>Black Forest Medical GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005752</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12109080</emdnCode>
    <emdnDescription>VARIOUS NEUROLOGY AND NEUROSURGERY INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3001-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T21:32:59.803Z</lastUpdated>
  </row>
  <row>
    <udiDi>04250413410927</udiDi>
    <basicUdiDi>42504134NARCOguideD6</basicUdiDi>
    <tradeName>NARCOguide, Basic-Version</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SOMNOmedics AG</manufacturerName>
    <manufacturerSrn>DE-PR-000042026</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12100302</emdnCode>
    <emdnDescription>ELECTROENCEPHALOGRAPHS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DOA100</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-30T21:32:53.396Z</lastUpdated>
  </row>
  <row>
    <udiDi>04250413409099</udiDi>
    <basicUdiDi>42504134Gurt-AHA6</basicUdiDi>
    <tradeName>Application Mount with retaining clip</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SOMNOmedics AG</manufacturerName>
    <manufacturerSrn>DE-MF-000006921</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12100580</emdnCode>
    <emdnDescription>POLYSOMNOGRAPHY INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TOS813</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T21:32:38.994Z</lastUpdated>
  </row>
  <row>
    <udiDi>04250413407224</udiDi>
    <basicUdiDi>42504134JackCableBY</basicUdiDi>
    <tradeName>Y-cable 3.5mm stereo</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SOMNOmedics AG</manufacturerName>
    <manufacturerSrn>DE-MF-000006921</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12100580</emdnCode>
    <emdnDescription>POLYSOMNOGRAPHY INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BT-K0000085</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T21:32:36.583Z</lastUpdated>
  </row>
  <row>
    <udiDi>04250413407217</udiDi>
    <basicUdiDi>42504134NG-Ag8X</basicUdiDi>
    <tradeName>EEG-Electrode</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SOMNOmedics AG</manufacturerName>
    <manufacturerSrn>DE-MF-000006921</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12100385</emdnCode>
    <emdnDescription>ELECTROENCEPHALOGRAPHY INSTRUMENTS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SEN007/N</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T21:32:34.983Z</lastUpdated>
  </row>
  <row>
    <udiDi>04250413407026</udiDi>
    <basicUdiDi>42504134SOMNOscreenplusEQ</basicUdiDi>
    <tradeName>SOMNOscreen plus RC easy (AASM)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SOMNOmedics AG</manufacturerName>
    <manufacturerSrn>DE-PR-000042026</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12100501</emdnCode>
    <emdnDescription>POLYSOMNOGRAPHS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SSP500A</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-30T21:32:34.193Z</lastUpdated>
  </row>
  <row>
    <udiDi>04250413406456</udiDi>
    <basicUdiDi>42504134ABPM-ManCX</basicUdiDi>
    <tradeName>Cuff ABPMpro for right arm</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SOMNOmedics AG</manufacturerName>
    <manufacturerSrn>DE-MF-000006921</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12100380</emdnCode>
    <emdnDescription>ELECTROENCEPHALOGRAPHY INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ABP500R</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T21:32:30.180Z</lastUpdated>
  </row>
</eudamedExport>