<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>B14004450</udiDi>
    <basicUdiDi>++B140BATTERYKITHP</basicUdiDi>
    <tradeName>Rechargeable Battery Kit</tradeName>
    <deviceName>Rechargeable Battery Kit</deviceName>
    <manufacturerName>BRAEBON Medical Corporation</manufacturerName>
    <manufacturerSrn>CA-PR-000013743</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>0445</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-15T11:51:44.984Z</lastUpdated>
  </row>
  <row>
    <udiDi>B140041221</udiDi>
    <basicUdiDi>++B140BATTERIESYY</basicUdiDi>
    <tradeName>1/2 AA Li-Ion Rechargeable Batteries</tradeName>
    <deviceName>1/2 AA Lithium Battery Charger</deviceName>
    <manufacturerName>BRAEBON Medical Corporation</manufacturerName>
    <manufacturerSrn>CA-MF-000002190</manufacturerSrn>
    <authorisedRepresentativeName>AR Experts B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000023989</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12100580</emdnCode>
    <emdnDescription>POLYSOMNOGRAPHY INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0412-2</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T11:51:44.190Z</lastUpdated>
  </row>
  <row>
    <udiDi>B14003500</udiDi>
    <basicUdiDi>++B140ConnectSW</basicUdiDi>
    <tradeName>Dual Keyhole Connector to 2 mm Male Safety Pin Connector Cable</tradeName>
    <deviceName>Connector Cables</deviceName>
    <manufacturerName>BRAEBON Medical Corporation</manufacturerName>
    <manufacturerSrn>CA-MF-000002190</manufacturerSrn>
    <authorisedRepresentativeName>AR Experts B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000023989</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12100580</emdnCode>
    <emdnDescription>POLYSOMNOGRAPHY INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0350</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T11:51:40.185Z</lastUpdated>
  </row>
  <row>
    <udiDi>B14003100</udiDi>
    <basicUdiDi>++B140FlowH7</basicUdiDi>
    <tradeName>Pneumo Flow Sensor</tradeName>
    <deviceName>Pneumo Flow Sensor</deviceName>
    <manufacturerName>BRAEBON Medical Corporation</manufacturerName>
    <manufacturerSrn>CA-MF-000002190</manufacturerSrn>
    <authorisedRepresentativeName>AR Experts B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000023989</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12100580</emdnCode>
    <emdnDescription>POLYSOMNOGRAPHY INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0310</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T11:51:39.385Z</lastUpdated>
  </row>
  <row>
    <udiDi>B14003050</udiDi>
    <basicUdiDi>++B140TapeHH</basicUdiDi>
    <tradeName>Paper Tape</tradeName>
    <deviceName>Paper Tape</deviceName>
    <manufacturerName>BRAEBON Medical Corporation</manufacturerName>
    <manufacturerSrn>CA-MF-000002190</manufacturerSrn>
    <authorisedRepresentativeName>AR Experts B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000023989</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12100585</emdnCode>
    <emdnDescription>POLYSOMNOGRAPHY INSTRUMENTS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0305</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T11:51:38.590Z</lastUpdated>
  </row>
  <row>
    <udiDi>B14003030</udiDi>
    <basicUdiDi>++B140Connector4X</basicUdiDi>
    <tradeName>Male to Male Luer Adapter</tradeName>
    <deviceName>Male to Male Luer Adapter</deviceName>
    <manufacturerName>BRAEBON Medical Corporation</manufacturerName>
    <manufacturerSrn>CA-MF-000002190</manufacturerSrn>
    <authorisedRepresentativeName>AR Experts B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000023989</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12100585</emdnCode>
    <emdnDescription>POLYSOMNOGRAPHY INSTRUMENTS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0303</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T11:51:37.784Z</lastUpdated>
  </row>
  <row>
    <udiDi>++B1408110UN</udiDi>
    <basicUdiDi>++B140PatientKit6H</basicUdiDi>
    <tradeName>MediByte Patient Kit</tradeName>
    <deviceName>MediByte Patient Kit</deviceName>
    <manufacturerName>BRAEBON Medical Corporation</manufacturerName>
    <manufacturerSrn>CA-PR-000013743</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12100585</emdnCode>
    <emdnDescription>POLYSOMNOGRAPHY INSTRUMENTS - CONSUMABLES</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>8110</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-15T11:46:28.452Z</lastUpdated>
  </row>
  <row>
    <udiDi>++B1400534TY</udiDi>
    <basicUdiDi>++B140BodyPositionVB</basicUdiDi>
    <tradeName>Ultima Body Position Sensor with 2.5 mm Phone Connector</tradeName>
    <deviceName>Ultima Body Position Sensor</deviceName>
    <manufacturerName>BRAEBON Medical Corporation</manufacturerName>
    <manufacturerSrn>CA-MF-000002190</manufacturerSrn>
    <authorisedRepresentativeName>AR Experts B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000023989</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12100580</emdnCode>
    <emdnDescription>POLYSOMNOGRAPHY INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>0534</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T11:46:27.649Z</lastUpdated>
  </row>
  <row>
    <udiDi>40606959032215</udiDi>
    <basicUdiDi>B-40606959032215</basicUdiDi>
    <tradeName>Pro-Flow Nasal Cannula, Adult, 16”</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Pro-Tech Services, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000002300</manufacturerSrn>
    <authorisedRepresentativeName>Respironics Deutschland GmbH &amp; Co.KG</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006164</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12100580</emdnCode>
    <emdnDescription>POLYSOMNOGRAPHY INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>P1390</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-11T16:02:12.662Z</lastUpdated>
  </row>
  <row>
    <udiDi>30606959032256</udiDi>
    <basicUdiDi>B-30606959032256</basicUdiDi>
    <tradeName>Pro-Flow Plus Nasal Oral Cannula, Pediatric</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Pro-Tech Services, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000002300</manufacturerSrn>
    <authorisedRepresentativeName>Respironics Deutschland GmbH &amp; Co.KG</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006164</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12100580</emdnCode>
    <emdnDescription>POLYSOMNOGRAPHY INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>P1354</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-11T15:03:20.160Z</lastUpdated>
  </row>
  <row>
    <udiDi>30606959032249</udiDi>
    <basicUdiDi>B-30606959032249</basicUdiDi>
    <tradeName>Pro-Flow Nasal Oral Cannula, Adult</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Pro-Tech Services, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000002300</manufacturerSrn>
    <authorisedRepresentativeName>Respironics Deutschland GmbH &amp; Co.KG</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006164</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12100580</emdnCode>
    <emdnDescription>POLYSOMNOGRAPHY INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>P1295</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-11T15:03:16.138Z</lastUpdated>
  </row>
  <row>
    <udiDi>15694311111603</udiDi>
    <basicUdiDi>B-15694311111603</basicUdiDi>
    <tradeName>C1s Kit EU</tradeName>
    <deviceName>Nox C1s Kit</deviceName>
    <manufacturerName>Nox Medical</manufacturerName>
    <manufacturerSrn>IS-MF-000000950</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12100501</emdnCode>
    <emdnDescription>POLYSOMNOGRAPHS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>544023</reference>
    <placedOnMarketCountry>Iceland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T05:44:28.017Z</lastUpdated>
  </row>
  <row>
    <udiDi>15694311111559</udiDi>
    <basicUdiDi>B-15694311111559</basicUdiDi>
    <tradeName>A1s Recorder</tradeName>
    <deviceName>A1s Recorder</deviceName>
    <manufacturerName>Nox Medical</manufacturerName>
    <manufacturerSrn>IS-MF-000000950</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12100501</emdnCode>
    <emdnDescription>POLYSOMNOGRAPHS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>561411</reference>
    <placedOnMarketCountry>Iceland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T05:44:27.215Z</lastUpdated>
  </row>
  <row>
    <udiDi>15694311111436</udiDi>
    <basicUdiDi>B-15694311111436</basicUdiDi>
    <tradeName>T3s Recorder EU</tradeName>
    <deviceName>T3s Recorder EU</deviceName>
    <manufacturerName>Nox Medical</manufacturerName>
    <manufacturerSrn>IS-MF-000000950</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12100501</emdnCode>
    <emdnDescription>POLYSOMNOGRAPHS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>561011</reference>
    <placedOnMarketCountry>Iceland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T05:44:26.423Z</lastUpdated>
  </row>
  <row>
    <udiDi>15694311111313</udiDi>
    <basicUdiDi>B-15694311111313</basicUdiDi>
    <tradeName>Noxturnal Language Pack CD</tradeName>
    <deviceName>Noxturnal Language Pack CD</deviceName>
    <manufacturerName>Nox Medical</manufacturerName>
    <manufacturerSrn>IS-MF-000000950</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12100582</emdnCode>
    <emdnDescription>POLYSOMNOGRAPHY INSTRUMENTS - SOFTWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>539011</reference>
    <placedOnMarketCountry>Iceland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T05:44:22.414Z</lastUpdated>
  </row>
  <row>
    <udiDi>15694311111146</udiDi>
    <basicUdiDi>B-15694311111146</basicUdiDi>
    <tradeName>Nox C1 Kit</tradeName>
    <deviceName>Nox C1 Kit</deviceName>
    <manufacturerName>Nox Medical</manufacturerName>
    <manufacturerSrn>IS-MF-000000950</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12100501</emdnCode>
    <emdnDescription>POLYSOMNOGRAPHS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>544020</reference>
    <placedOnMarketCountry>Iceland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T05:44:21.621Z</lastUpdated>
  </row>
  <row>
    <udiDi>15694311110590</udiDi>
    <basicUdiDi>B-15694311110590</basicUdiDi>
    <tradeName>Nox C1 Access Point</tradeName>
    <deviceName>Nox C1 Access Point</deviceName>
    <manufacturerName>Nox Medical</manufacturerName>
    <manufacturerSrn>IS-MF-000000950</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12100501</emdnCode>
    <emdnDescription>POLYSOMNOGRAPHS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NOX-SCOM1</reference>
    <placedOnMarketCountry>Iceland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T05:44:20.821Z</lastUpdated>
  </row>
  <row>
    <udiDi>15694311110255</udiDi>
    <basicUdiDi>B-15694311110255</basicUdiDi>
    <tradeName>Noxturnal®</tradeName>
    <deviceName>Noxturnal®</deviceName>
    <manufacturerName>Nox Medical</manufacturerName>
    <manufacturerSrn>IS-MF-000000950</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12100582</emdnCode>
    <emdnDescription>POLYSOMNOGRAPHY INSTRUMENTS - SOFTWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>539010</reference>
    <placedOnMarketCountry>Iceland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T05:44:20.017Z</lastUpdated>
  </row>
  <row>
    <udiDi>15694311110231</udiDi>
    <basicUdiDi>B-15694311110231</basicUdiDi>
    <tradeName>Nox Nasal Pressure Cannula with Filter</tradeName>
    <deviceName>Nox Nasal Pressure Cannula with Filter</deviceName>
    <manufacturerName>Nox Medical</manufacturerName>
    <manufacturerSrn>IS-MF-000000950</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12100585</emdnCode>
    <emdnDescription>POLYSOMNOGRAPHY INSTRUMENTS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>552010</reference>
    <placedOnMarketCountry>Iceland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T05:44:16.014Z</lastUpdated>
  </row>
  <row>
    <udiDi>15694311110019</udiDi>
    <basicUdiDi>B-15694311110019</basicUdiDi>
    <tradeName>Noxturnal® App</tradeName>
    <deviceName>Noxturnal® App</deviceName>
    <manufacturerName>Nox Medical</manufacturerName>
    <manufacturerSrn>IS-MF-000000950</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12100582</emdnCode>
    <emdnDescription>POLYSOMNOGRAPHY INSTRUMENTS - SOFTWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>536210</reference>
    <placedOnMarketCountry>Iceland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T05:44:15.216Z</lastUpdated>
  </row>
</eudamedExport>