<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
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    <udiDi>D-799680-001EM</udiDi>
    <basicUdiDi>B-799680-001EM</basicUdiDi>
    <tradeName>PCI GASES</tradeName>
    <deviceName>DEPLOYABLE OXYGEN CONCENTRATION SYSTEM</deviceName>
    <manufacturerName>Pacific Consolidated Industries LLC</manufacturerName>
    <manufacturerSrn>US-MF-000034081</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12159004</emdnCode>
    <emdnDescription>OXYGEN CONCENTRATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>799680-001</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:27:10.144Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-799676-002GC</udiDi>
    <basicUdiDi>B-799676-002GC</basicUdiDi>
    <tradeName>DOCS</tradeName>
    <deviceName>MDOCS 500R-55-CE</deviceName>
    <manufacturerName>Pacific Consolidated Industries LLC</manufacturerName>
    <manufacturerSrn>US-MF-000034081</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12159004</emdnCode>
    <emdnDescription>OXYGEN CONCENTRATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>799676-002</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:27:09.342Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-799341-002BT</udiDi>
    <basicUdiDi>B-799341-002BT</basicUdiDi>
    <tradeName>DOCS</tradeName>
    <deviceName>DOCS 200-55-CE MEDICAL (MDOCS), DEPLOYABLE OXYGEN CONCENTRATION SYSTEM,</deviceName>
    <manufacturerName>Pacific Consolidated Industries LLC</manufacturerName>
    <manufacturerSrn>US-MF-000034081</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12159004</emdnCode>
    <emdnDescription>OXYGEN CONCENTRATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>799341-002</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:27:08.545Z</lastUpdated>
  </row>
  <row>
    <udiDi>36643511001538</udiDi>
    <basicUdiDi>B-36643511001538</basicUdiDi>
    <tradeName>ATOMISOR AEROSONIC+</tradeName>
    <deviceName></deviceName>
    <manufacturerName>La Diffusion Technique Française</manufacturerName>
    <manufacturerSrn>FR-MF-000009060</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12159002</emdnCode>
    <emdnDescription>AEROSOL EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AOHBOX+</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-11T15:34:00.648Z</lastUpdated>
  </row>
  <row>
    <udiDi>16970529950951</udiDi>
    <basicUdiDi>B-16970529950951</basicUdiDi>
    <tradeName>oxygen concentrator filter</tradeName>
    <deviceName>oxygen concentrator filter</deviceName>
    <manufacturerName>SHANDONG ZHENFU MEDICAL DEVICE CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000031319</manufacturerSrn>
    <authorisedRepresentativeName>Eunitor GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005081</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12159004</emdnCode>
    <emdnDescription>OXYGEN CONCENTRATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ZF-055</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-11T06:23:20.609Z</lastUpdated>
  </row>
  <row>
    <udiDi>04250892907345</udiDi>
    <basicUdiDi>42508929012112AG3</basicUdiDi>
    <tradeName>04250892907345</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Jaeger Medical GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000007090</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12159082</emdnCode>
    <emdnDescription>VAROUS PNEUMOLOGY AND RESPIRATORY PHYSIOPATHOLOGY INSTRUMENTS - SOFTWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>V-770968</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-11T01:28:18.619Z</lastUpdated>
  </row>
  <row>
    <udiDi>04250892907888</udiDi>
    <basicUdiDi>42508929031911QS</basicUdiDi>
    <tradeName>04250892907888</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Jaeger Medical GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000007090</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12159080</emdnCode>
    <emdnDescription>VAROUS PNEUMOLOGY AND RESPIRATORY PHYSIOPATHOLOGY INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>706596</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-11T01:28:18.590Z</lastUpdated>
  </row>
  <row>
    <udiDi>04250892908281</udiDi>
    <basicUdiDi>42508929011861QE</basicUdiDi>
    <tradeName>04250892908281</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Jaeger Medical GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000007090</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12159085</emdnCode>
    <emdnDescription>VAROUS PNEUMOLOGY AND RESPIRATORY PHYSIOPATHOLOGY INSTRUMENTS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>V-861360</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-11T01:28:18.562Z</lastUpdated>
  </row>
  <row>
    <udiDi>04250892908793</udiDi>
    <basicUdiDi>42508929041512AHT</basicUdiDi>
    <tradeName>04250892908793</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Jaeger Medical GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000007090</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12159099</emdnCode>
    <emdnDescription>VAROUS PNEUMOLOGY AND RESPIRATORY PHYSIOPATHOLOGY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>V-178602</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-11T01:28:18.502Z</lastUpdated>
  </row>
  <row>
    <udiDi>04250892908809</udiDi>
    <basicUdiDi>42508929041512AHT</basicUdiDi>
    <tradeName>04250892908809</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Jaeger Medical GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000007090</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12159099</emdnCode>
    <emdnDescription>VAROUS PNEUMOLOGY AND RESPIRATORY PHYSIOPATHOLOGY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>V-178603</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-11T01:28:18.469Z</lastUpdated>
  </row>
  <row>
    <udiDi>08698934521559</udiDi>
    <basicUdiDi>B-08698934521559</basicUdiDi>
    <tradeName>Hikoneb Oxybreath 10L</tradeName>
    <deviceName>Oxygen Concentrator</deviceName>
    <manufacturerName>KARE MEDiKAL VE ANALiTiK CiH. SAN. VE TiC. LTD. STi.</manufacturerName>
    <manufacturerSrn>TR-MF-000020956</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12159004</emdnCode>
    <emdnDescription>OXYGEN CONCENTRATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>M000021</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-09T12:35:38.140Z</lastUpdated>
  </row>
  <row>
    <udiDi>08698934521481</udiDi>
    <basicUdiDi>B-08698934521481</basicUdiDi>
    <tradeName>Hikoneb Oxybreath Mini 3</tradeName>
    <deviceName>Oxygen Concentrator</deviceName>
    <manufacturerName>KARE MEDiKAL VE ANALiTiK CiH. SAN. VE TiC. LTD. STi.</manufacturerName>
    <manufacturerSrn>TR-MF-000020956</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12159004</emdnCode>
    <emdnDescription>OXYGEN CONCENTRATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>M000346</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-09T12:35:36.706Z</lastUpdated>
  </row>
  <row>
    <udiDi>08698934521474</udiDi>
    <basicUdiDi>B-08698934521474</basicUdiDi>
    <tradeName>Hikoneb Oxybreath Mini 5</tradeName>
    <deviceName>Oxygen Concentrator</deviceName>
    <manufacturerName>KARE MEDiKAL VE ANALiTiK CiH. SAN. VE TiC. LTD. STi.</manufacturerName>
    <manufacturerSrn>TR-MF-000020956</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12159004</emdnCode>
    <emdnDescription>OXYGEN CONCENTRATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>M000025</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-09T12:35:35.744Z</lastUpdated>
  </row>
  <row>
    <udiDi>08698918583443</udiDi>
    <basicUdiDi>B-08698918583443</basicUdiDi>
    <tradeName>Sümer</tradeName>
    <deviceName>OXYFRESH 2400 OKSİJEN ÜRETİM VE DEPOLAMA SİSTEMİ  2400 L</deviceName>
    <manufacturerName>SÜMER ULUSLARARASI SANAYİ VE TİCARET ANONİM ŞİRKETİ</manufacturerName>
    <manufacturerSrn>TR-MF-000022362</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12159004</emdnCode>
    <emdnDescription>OXYGEN CONCENTRATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>---</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-09T12:24:42.748Z</lastUpdated>
  </row>
  <row>
    <udiDi>08698918583436</udiDi>
    <basicUdiDi>B-08698918583436</basicUdiDi>
    <tradeName>Sümer</tradeName>
    <deviceName>OXYFRESH 1800 OKSİJEN ÜRETİM VE DEPOLAMA SİSTEMİ 1800 L</deviceName>
    <manufacturerName>SÜMER ULUSLARARASI SANAYİ VE TİCARET ANONİM ŞİRKETİ</manufacturerName>
    <manufacturerSrn>TR-MF-000022362</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12159004</emdnCode>
    <emdnDescription>OXYGEN CONCENTRATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>---</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-09T12:24:41.966Z</lastUpdated>
  </row>
  <row>
    <udiDi>08698918583429</udiDi>
    <basicUdiDi>B-08698918583429</basicUdiDi>
    <tradeName>Sümer</tradeName>
    <deviceName>OXYFRESH 1500 OKSİJEN ÜRETİM VE DEPOLAMA SİSTEMİ  1500 L</deviceName>
    <manufacturerName>SÜMER ULUSLARARASI SANAYİ VE TİCARET ANONİM ŞİRKETİ</manufacturerName>
    <manufacturerSrn>TR-MF-000022362</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12159004</emdnCode>
    <emdnDescription>OXYGEN CONCENTRATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>---</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-09T12:24:37.972Z</lastUpdated>
  </row>
  <row>
    <udiDi>08698918583412</udiDi>
    <basicUdiDi>B-08698918583412</basicUdiDi>
    <tradeName>Sümer</tradeName>
    <deviceName>OXYFRESH 1250 OKSİJEN ÜRETİM VE DEPOLAMA SİSTEMİ 1250 L</deviceName>
    <manufacturerName>SÜMER ULUSLARARASI SANAYİ VE TİCARET ANONİM ŞİRKETİ</manufacturerName>
    <manufacturerSrn>TR-MF-000022362</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12159004</emdnCode>
    <emdnDescription>OXYGEN CONCENTRATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>---</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-09T12:24:37.152Z</lastUpdated>
  </row>
  <row>
    <udiDi>08698918583405</udiDi>
    <basicUdiDi>B-08698918583405</basicUdiDi>
    <tradeName>Sümer</tradeName>
    <deviceName>OXYFRESH 1000 OKSİJEN ÜRETİM VE DEPOLAMA SİSTEMİ  1000 L</deviceName>
    <manufacturerName>SÜMER ULUSLARARASI SANAYİ VE TİCARET ANONİM ŞİRKETİ</manufacturerName>
    <manufacturerSrn>TR-MF-000022362</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12159004</emdnCode>
    <emdnDescription>OXYGEN CONCENTRATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>---</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-09T12:24:36.364Z</lastUpdated>
  </row>
  <row>
    <udiDi>08698918583399</udiDi>
    <basicUdiDi>B-08698918583399</basicUdiDi>
    <tradeName>Sümer</tradeName>
    <deviceName>OXYFRESH 750 OKSİJEN ÜRETİM VE DEPOLAMA SİSTEMİ 750 L</deviceName>
    <manufacturerName>SÜMER ULUSLARARASI SANAYİ VE TİCARET ANONİM ŞİRKETİ</manufacturerName>
    <manufacturerSrn>TR-MF-000022362</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12159004</emdnCode>
    <emdnDescription>OXYGEN CONCENTRATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>---</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-09T12:24:35.550Z</lastUpdated>
  </row>
  <row>
    <udiDi>08698918583368</udiDi>
    <basicUdiDi>B-08698918583368</basicUdiDi>
    <tradeName>Sümer</tradeName>
    <deviceName>OXYFRESH 400 OKSİJEN ÜRETİM VE DEPOLAMA SİSTEMİ 400 L</deviceName>
    <manufacturerName>SÜMER ULUSLARARASI SANAYİ VE TİCARET ANONİM ŞİRKETİ</manufacturerName>
    <manufacturerSrn>TR-MF-000022362</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12159004</emdnCode>
    <emdnDescription>OXYGEN CONCENTRATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>---</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-09T12:24:31.543Z</lastUpdated>
  </row>
</eudamedExport>