<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>08800012330001</udiDi>
    <basicUdiDi>B-08800012330001</basicUdiDi>
    <tradeName>08800012330001</tradeName>
    <deviceName>Fetal monitor</deviceName>
    <manufacturerName>Bistos Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000035951</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12080101</emdnCode>
    <emdnDescription>FOETAL MONITORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BT-300</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-09T16:32:37.808Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800012325007</udiDi>
    <basicUdiDi>B-08800012325007</basicUdiDi>
    <tradeName>08800012325007</tradeName>
    <deviceName>Ultrasound Doppler system with Probes</deviceName>
    <manufacturerName>Bistos Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000035951</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12080103</emdnCode>
    <emdnDescription>FOETAL HEARTBEAT DETECTORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BT-250</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-09T16:32:35.139Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800012320064</udiDi>
    <basicUdiDi>B-08800012320064</basicUdiDi>
    <tradeName>Hi-dop</tradeName>
    <deviceName>Ultrasound Doppler system with Probes</deviceName>
    <manufacturerName>Bistos Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000035951</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12080103</emdnCode>
    <emdnDescription>FOETAL HEARTBEAT DETECTORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BT-200V</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-09T16:32:33.540Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800012322013</udiDi>
    <basicUdiDi>B-08800012322013</basicUdiDi>
    <tradeName>Hi-bebe S</tradeName>
    <deviceName>Ultrasound Doppler system with Probes</deviceName>
    <manufacturerName>Bistos Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000035951</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12080103</emdnCode>
    <emdnDescription>FOETAL HEARTBEAT DETECTORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BT-220C</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-09T16:32:32.734Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800012320002</udiDi>
    <basicUdiDi>B-08800012320002</basicUdiDi>
    <tradeName>Hi-bebe</tradeName>
    <deviceName>Ultrasound Doppler system with Probes</deviceName>
    <manufacturerName>Bistos Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000035951</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12080103</emdnCode>
    <emdnDescription>FOETAL HEARTBEAT DETECTORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BT-200L</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-09T16:32:31.143Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800012320033</udiDi>
    <basicUdiDi>B-08800012320033</basicUdiDi>
    <tradeName>Hi-bebe</tradeName>
    <deviceName>Ultrasound Doppler system with Probes</deviceName>
    <manufacturerName>Bistos Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000035951</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12080103</emdnCode>
    <emdnDescription>FOETAL HEARTBEAT DETECTORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BT-200T</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-09T16:32:28.839Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800012315015</udiDi>
    <basicUdiDi>B-08800012315015</basicUdiDi>
    <tradeName>Hi bebe super</tradeName>
    <deviceName>Electric Breast Pump</deviceName>
    <manufacturerName>Bistos Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000035951</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12080303</emdnCode>
    <emdnDescription>BREAST PUMPS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BT-150B</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-09T16:32:15.079Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800012310126</udiDi>
    <basicUdiDi>B-08800012310126</basicUdiDi>
    <tradeName>Hi bebe plus</tradeName>
    <deviceName>Electric Breast Pump</deviceName>
    <manufacturerName>Bistos Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000035951</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12080303</emdnCode>
    <emdnDescription>BREAST PUMPS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BT-100</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-09T16:32:12.665Z</lastUpdated>
  </row>
  <row>
    <udiDi>08699412422054</udiDi>
    <basicUdiDi>B-08699412422054</basicUdiDi>
    <tradeName>PLASTI-MED</tradeName>
    <deviceName>IUI CATHETER CANNULA 6/8 FR WITH STYLET</deviceName>
    <manufacturerName>Plasti-med Plastik Medikal Ürünler San. ve Tic. Ltd. Şti.</manufacturerName>
    <manufacturerSrn>TR-MF-000032251</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12080299</emdnCode>
    <emdnDescription>GYNAECOLOGY AND FERTILITY TREATMENT INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>544005</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-09T14:37:40.421Z</lastUpdated>
  </row>
  <row>
    <udiDi>08699412422023</udiDi>
    <basicUdiDi>B-08699412422023</basicUdiDi>
    <tradeName>PLASTI-MED</tradeName>
    <deviceName>IUI CATHETER CANNULA 6/8 FR</deviceName>
    <manufacturerName>Plasti-med Plastik Medikal Ürünler San. ve Tic. Ltd. Şti.</manufacturerName>
    <manufacturerSrn>TR-MF-000032251</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12080299</emdnCode>
    <emdnDescription>GYNAECOLOGY AND FERTILITY TREATMENT INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>544002</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-09T14:37:34.436Z</lastUpdated>
  </row>
  <row>
    <udiDi>08698943381601</udiDi>
    <basicUdiDi>B-08698943381601</basicUdiDi>
    <tradeName>TUR-MED HASTANE MALZ. SAN. TİC. LTD. ŞTİ.</tradeName>
    <deviceName>Gynecalogical Examination Chair(Three Motor)</deviceName>
    <manufacturerName>TUR-MED HASTANE MALZ. SAN. TIC. LTD. ŞTI.</manufacturerName>
    <manufacturerSrn>TR-MF-000018608</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z120899</emdnCode>
    <emdnDescription>GYNAECOLOGY AND MATERNAL-INFANTS INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TM-A 1021</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-09T13:11:09.130Z</lastUpdated>
  </row>
  <row>
    <udiDi>08698918583276</udiDi>
    <basicUdiDi>B-08698918583276</basicUdiDi>
    <tradeName>Sümer</tradeName>
    <deviceName>ADELA BP5 ANNE SÜTÜ SAĞMA POMPASI</deviceName>
    <manufacturerName>SÜMER ULUSLARARASI SANAYİ VE TİCARET ANONİM ŞİRKETİ</manufacturerName>
    <manufacturerSrn>TR-MF-000022362</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12080303</emdnCode>
    <emdnDescription>BREAST PUMPS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>---</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-09T12:24:03.497Z</lastUpdated>
  </row>
  <row>
    <udiDi>08698918583269</udiDi>
    <basicUdiDi>B-08698918583269</basicUdiDi>
    <tradeName>Sümer</tradeName>
    <deviceName>ADELA BP4 ANNE SÜTÜ SAĞMA POMPASI</deviceName>
    <manufacturerName>SÜMER ULUSLARARASI SANAYİ VE TİCARET ANONİM ŞİRKETİ</manufacturerName>
    <manufacturerSrn>TR-MF-000022362</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12080303</emdnCode>
    <emdnDescription>BREAST PUMPS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>---</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-09T12:23:59.718Z</lastUpdated>
  </row>
  <row>
    <udiDi>08698918583252</udiDi>
    <basicUdiDi>B-08698918583252</basicUdiDi>
    <tradeName>Sümer</tradeName>
    <deviceName>ADELA BP3 ANNE SÜTÜ SAĞMA POMPASI</deviceName>
    <manufacturerName>SÜMER ULUSLARARASI SANAYİ VE TİCARET ANONİM ŞİRKETİ</manufacturerName>
    <manufacturerSrn>TR-MF-000022362</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12080303</emdnCode>
    <emdnDescription>BREAST PUMPS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>---</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-09T12:23:58.675Z</lastUpdated>
  </row>
  <row>
    <udiDi>08698918583245</udiDi>
    <basicUdiDi>B-08698918583245</basicUdiDi>
    <tradeName>Sümer</tradeName>
    <deviceName>ADELA BP2 ANNE SÜTÜ SAĞMA POMPASI</deviceName>
    <manufacturerName>SÜMER ULUSLARARASI SANAYİ VE TİCARET ANONİM ŞİRKETİ</manufacturerName>
    <manufacturerSrn>TR-MF-000022362</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12080303</emdnCode>
    <emdnDescription>BREAST PUMPS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>---</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-09T12:23:57.871Z</lastUpdated>
  </row>
  <row>
    <udiDi>08698918583238</udiDi>
    <basicUdiDi>B-08698918583238</basicUdiDi>
    <tradeName>Sümer</tradeName>
    <deviceName>ADELA BP1 ANNE SÜTÜ SAĞMA POMPASI</deviceName>
    <manufacturerName>SÜMER ULUSLARARASI SANAYİ VE TİCARET ANONİM ŞİRKETİ</manufacturerName>
    <manufacturerSrn>TR-MF-000022362</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12080303</emdnCode>
    <emdnDescription>BREAST PUMPS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>---</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-09T12:23:57.066Z</lastUpdated>
  </row>
  <row>
    <udiDi>08698887080639</udiDi>
    <basicUdiDi>B-08698887080639</basicUdiDi>
    <tradeName>Babynest H-100 Transport Incubator</tradeName>
    <deviceName>Transport Incubator</deviceName>
    <manufacturerName>ERTUNÇ ÖZCAN</manufacturerName>
    <manufacturerSrn>TR-MF-000016665</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z1208040302</emdnCode>
    <emdnDescription>MOBILE NEONATAL INCUBATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>105</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-09T11:55:17.027Z</lastUpdated>
  </row>
  <row>
    <udiDi>08698887080158</udiDi>
    <basicUdiDi>B-08698887080158</basicUdiDi>
    <tradeName>Blue Angel LED Phototherapy Device</tradeName>
    <deviceName>LED Phototherapy Device</deviceName>
    <manufacturerName>ERTUNÇ ÖZCAN</manufacturerName>
    <manufacturerSrn>TR-MF-000016665</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12080401</emdnCode>
    <emdnDescription>PAEDIATRIC PHOTOTHERAPY EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>205</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-09T11:55:15.396Z</lastUpdated>
  </row>
  <row>
    <udiDi>03760012570157</udiDi>
    <basicUdiDi>376001257BCCDisposableR4</basicUdiDi>
    <tradeName>BiliCocoon™ Bag Disposable - Small</tradeName>
    <deviceName></deviceName>
    <manufacturerName>NEOMEDLIGHT</manufacturerName>
    <manufacturerSrn>FR-MF-000004044</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12080485</emdnCode>
    <emdnDescription>NEONATOLOGY INSTRUMENTS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BCC221-S</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-08T13:57:21.250Z</lastUpdated>
  </row>
  <row>
    <udiDi>03760012570195</udiDi>
    <basicUdiDi>376001257BCCDisposableR4</basicUdiDi>
    <tradeName>BiliCocoon™ Nest Disposable</tradeName>
    <deviceName></deviceName>
    <manufacturerName>NEOMEDLIGHT</manufacturerName>
    <manufacturerSrn>FR-MF-000004044</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12080485</emdnCode>
    <emdnDescription>NEONATOLOGY INSTRUMENTS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BCC121</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-08T13:57:21.172Z</lastUpdated>
  </row>
</eudamedExport>