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    <udiDi>18586021470415</udiDi>
    <basicUdiDi>602147TPNSETAL</basicUdiDi>
    <tradeName>Tubing Systems and Accessories for Fluid Delivery</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Sky Medical a.s.</manufacturerName>
    <manufacturerSrn>SK-MF-000001475</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>A04010101</emdnCode>
    <emdnDescription>WITHDRAWL AND ADMINISTRATION FILTERS (0.2-1.2 MICRONS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TP-SS0002</reference>
    <placedOnMarketCountry>Slovakia</placedOnMarketCountry>
    <lastUpdated>2026-07-31T13:52:48.547Z</lastUpdated>
  </row>
  <row>
    <udiDi>18586021470378</udiDi>
    <basicUdiDi>602147CLSET5L</basicUdiDi>
    <tradeName>Tubing Systems and Accessories for Fluid Delivery</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Sky Medical a.s.</manufacturerName>
    <manufacturerSrn>SK-MF-000001475</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>A03020102</emdnCode>
    <emdnDescription>HIGH PRESSURE EXTENSION LINES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CL-H15002</reference>
    <placedOnMarketCountry>Slovakia</placedOnMarketCountry>
    <lastUpdated>2026-07-31T13:52:47.752Z</lastUpdated>
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  <row>
    <udiDi>18586021470361</udiDi>
    <basicUdiDi>602147CMSET5T</basicUdiDi>
    <tradeName>Tubing Systems and Accessories for Fluid Delivery</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Sky Medical a.s.</manufacturerName>
    <manufacturerSrn>SK-MF-000001475</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>A03020102</emdnCode>
    <emdnDescription>HIGH PRESSURE EXTENSION LINES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CM-ML0002</reference>
    <placedOnMarketCountry>Slovakia</placedOnMarketCountry>
    <lastUpdated>2026-07-31T13:52:47.043Z</lastUpdated>
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  <row>
    <udiDi>06192493101716</udiDi>
    <basicUdiDi>61924931ENTERALFEEDSYRBT</basicUdiDi>
    <tradeName>06192493101716</tradeName>
    <deviceName>ENTERAL FEEDING SYRINGES</deviceName>
    <manufacturerName>Societe de Fabrication des Articles Pharmaceutiques SO.F.A.P Ltd</manufacturerName>
    <manufacturerSrn>TN-MF-000023623</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A020108</emdnCode>
    <emdnDescription>ENTERAL FEEDING SYRINGES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SA001EN,  SA002EN, SA2,5EN, SA003EN, SA005EN, SA010EN , SA020EN, SA050EN, SA060EN, SA100EN</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-31T13:51:09.026Z</lastUpdated>
  </row>
  <row>
    <udiDi>06192493101624</udiDi>
    <basicUdiDi>61924931HYPOPENNEEDLES6P</basicUdiDi>
    <tradeName>06192493101624</tradeName>
    <deviceName>Aiguilles pour sylo insuline à usage unique</deviceName>
    <manufacturerName>Societe de Fabrication des Articles Pharmaceutiques SO.F.A.P Ltd</manufacturerName>
    <manufacturerSrn>TN-MF-000023623</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A020108</emdnCode>
    <emdnDescription>ENTERAL FEEDING SYRINGES</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>IPNEI-29G-13mm</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-31T13:51:08.225Z</lastUpdated>
  </row>
  <row>
    <udiDi>06192493101051</udiDi>
    <basicUdiDi>61924931ROBINETY2</basicUdiDi>
    <tradeName>06192493101051</tradeName>
    <deviceName>Robinets à usage unique</deviceName>
    <manufacturerName>Societe de Fabrication des Articles Pharmaceutiques SO.F.A.P Ltd</manufacturerName>
    <manufacturerSrn>TN-MF-000023623</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A0703</emdnCode>
    <emdnDescription>STOPCOCKS</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>ROB3V1 -ROB3V2</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-31T13:51:06.620Z</lastUpdated>
  </row>
  <row>
    <udiDi>06192493100993</udiDi>
    <basicUdiDi>61924931RALLONGE76</basicUdiDi>
    <tradeName>PROLONGATEURS</tradeName>
    <deviceName>Prolongateur</deviceName>
    <manufacturerName>Societe de Fabrication des Articles Pharmaceutiques SO.F.A.P Ltd</manufacturerName>
    <manufacturerSrn>TN-MF-000023623</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A03020199</emdnCode>
    <emdnDescription>EXTENSIONS - OTHER</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>R1150D1S2C1C</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-31T13:51:02.636Z</lastUpdated>
  </row>
  <row>
    <udiDi>06192493100979</udiDi>
    <basicUdiDi>61924931INFMICROCONTROLSE</basicUdiDi>
    <tradeName>Perfuseur avec régulateur de débit de précision</tradeName>
    <deviceName>Perfuseur avec régulateur de débit de précision</deviceName>
    <manufacturerName>Societe de Fabrication des Articles Pharmaceutiques SO.F.A.P Ltd</manufacturerName>
    <manufacturerSrn>TN-MF-000023623</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A03010104</emdnCode>
    <emdnDescription>INFUSION MICRO-CONTROLLERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PS2a23HLLC</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-31T13:51:01.842Z</lastUpdated>
  </row>
  <row>
    <udiDi>06192493100955</udiDi>
    <basicUdiDi>61924931TRANSFUSEURNU</basicUdiDi>
    <tradeName>06192493100955</tradeName>
    <deviceName>Transfuseurs à usage unique</deviceName>
    <manufacturerName>Societe de Fabrication des Articles Pharmaceutiques SO.F.A.P Ltd</manufacturerName>
    <manufacturerSrn>TN-MF-000023623</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A03010102</emdnCode>
    <emdnDescription>INFUSION CONTROLLERS WITH FILTER (ALSO TRANSFUSION CONTROLLERS)</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>TSCA22LLCC</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-31T13:51:01.026Z</lastUpdated>
  </row>
  <row>
    <udiDi>06192493100887</udiDi>
    <basicUdiDi>61924931PERFUSEURW7</basicUdiDi>
    <tradeName>Perfuseus à usage unique</tradeName>
    <deviceName>perfuseur a usage unique</deviceName>
    <manufacturerName>Societe de Fabrication des Articles Pharmaceutiques SO.F.A.P Ltd</manufacturerName>
    <manufacturerSrn>TN-MF-000023623</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A03010103</emdnCode>
    <emdnDescription>INFUSION CONTROLLERS WITH FLOW REGULATOR</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PS2a23SLLA</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-31T13:51:00.219Z</lastUpdated>
  </row>
  <row>
    <udiDi>06192493100818</udiDi>
    <basicUdiDi>61924931AIGUILLEHYPUC</basicUdiDi>
    <tradeName>AIGUILLES 25G</tradeName>
    <deviceName>AIGUILLES HYPODERMIQUE</deviceName>
    <manufacturerName>Societe de Fabrication des Articles Pharmaceutiques SO.F.A.P Ltd</manufacturerName>
    <manufacturerSrn>TN-MF-000023623</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A0101010102</emdnCode>
    <emdnDescription>HYPODERMIC SYRINGE NEEDLES, W/O SAFETY SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AH25E</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-31T13:50:56.217Z</lastUpdated>
  </row>
  <row>
    <udiDi>06192493100771</udiDi>
    <basicUdiDi>61924931LLSYRINGESWNU5</basicUdiDi>
    <tradeName>SERINGUES 50ML LL SANS AIGUILLES</tradeName>
    <deviceName>Seringues Luer Lock, 3-pces sans aiguille, à usage unique</deviceName>
    <manufacturerName>Societe de Fabrication des Articles Pharmaceutiques SO.F.A.P Ltd</manufacturerName>
    <manufacturerSrn>TN-MF-000023623</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A020102020102</emdnCode>
    <emdnDescription>INFUSION AND IRRIGATION SYRINGES, LUER LOCK CONE, 3-PIECE WITHOUT NEEDLE, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SH050LL</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-31T13:50:55.416Z</lastUpdated>
  </row>
  <row>
    <udiDi>06192493100764</udiDi>
    <basicUdiDi>61924931CATHSYRINGESWNNT</basicUdiDi>
    <tradeName>Seringues Cathéter, 3-pces sans aiguille, à usage unique</tradeName>
    <deviceName>Seringues Cathéter, 3-pces sans aiguille, à usage unique</deviceName>
    <manufacturerName>Societe de Fabrication des Articles Pharmaceutiques SO.F.A.P Ltd</manufacturerName>
    <manufacturerSrn>TN-MF-000023623</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A02010203</emdnCode>
    <emdnDescription>INFUSION AND IRRIGATION SYRINGES, CATHETER CONE, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SA050CT</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-31T13:50:54.614Z</lastUpdated>
  </row>
  <row>
    <udiDi>06192493100733</udiDi>
    <basicUdiDi>61924931LSSYRINGESWN2Z</basicUdiDi>
    <tradeName>06192493100733</tradeName>
    <deviceName>Seringues LS, 3-pces sans aiguille, à usage unique</deviceName>
    <manufacturerName>Societe de Fabrication des Articles Pharmaceutiques SO.F.A.P Ltd</manufacturerName>
    <manufacturerSrn>TN-MF-000023623</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A020102020101</emdnCode>
    <emdnDescription>INFUSION AND IRRIGATION SYRINGES, LUER LOCK CONE, 3-PIECE WITH NEEDLE, SINGLE-USE</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>SH010LS</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-31T13:50:53.813Z</lastUpdated>
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  <row>
    <udiDi>06192493100603</udiDi>
    <basicUdiDi>61924931LSSYRINGESWITHNDX</basicUdiDi>
    <tradeName>seringues 2ml</tradeName>
    <deviceName>Seringues LS, 3-pces avec aiguille</deviceName>
    <manufacturerName>Societe de Fabrication des Articles Pharmaceutiques SO.F.A.P Ltd</manufacturerName>
    <manufacturerSrn>TN-MF-000023623</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A020102010201</emdnCode>
    <emdnDescription>INFUSION AND IRRIGATION SYRINGES, LUER CONE, 3-PIECE WITH NEEDLE, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SH002LS23D/SH002LS23E</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-31T13:50:49.808Z</lastUpdated>
  </row>
  <row>
    <udiDi>06192493100566</udiDi>
    <basicUdiDi>61924931INSULINSYRINGES3Z</basicUdiDi>
    <tradeName>Seringues Insuline, à usage unique</tradeName>
    <deviceName>Seringues Insuline, à usage unique</deviceName>
    <manufacturerName>Societe de Fabrication des Articles Pharmaceutiques SO.F.A.P Ltd</manufacturerName>
    <manufacturerSrn>TN-MF-000023623</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A02010601</emdnCode>
    <emdnDescription>INSULIN SYRINGES WITH FIXED NEEDLE, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SI001SE29B</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-31T13:50:49.012Z</lastUpdated>
  </row>
  <row>
    <udiDi>06192493100535</udiDi>
    <basicUdiDi>61924931TUBERCSYRINGES93</basicUdiDi>
    <tradeName>Seringue 1ml Tuberculine</tradeName>
    <deviceName>Seringue 1ml Tuberculine</deviceName>
    <manufacturerName>Societe de Fabrication des Articles Pharmaceutiques SO.F.A.P Ltd</manufacturerName>
    <manufacturerSrn>TN-MF-000023623</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A020109</emdnCode>
    <emdnDescription>TUBERCULIN SYRINGES, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SH001LS27B</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-31T13:50:48.224Z</lastUpdated>
  </row>
  <row>
    <udiDi>06192493100474</udiDi>
    <basicUdiDi>61924931LLSYRINGESWITHN4J</basicUdiDi>
    <tradeName>06192493100474</tradeName>
    <deviceName>INFUSION AND IRRIGATION SYRINGES, LUER LOCK CONE, 3-PIECE WITH NEEDLE, SINGLE-USE</deviceName>
    <manufacturerName>Societe de Fabrication des Articles Pharmaceutiques SO.F.A.P Ltd</manufacturerName>
    <manufacturerSrn>TN-MF-000023623</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A020102020101</emdnCode>
    <emdnDescription>INFUSION AND IRRIGATION SYRINGES, LUER LOCK CONE, 3-PIECE WITH NEEDLE, SINGLE-USE</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>SH010LL22F</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-31T13:50:47.432Z</lastUpdated>
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  <row>
    <udiDi>06192493100276</udiDi>
    <basicUdiDi>61924931MPRCIIAYD</basicUdiDi>
    <tradeName>STERMIX+</tradeName>
    <deviceName>Matériels de réduction des risques de contamination stériles et à usage unique avec filtre antibacterien</deviceName>
    <manufacturerName>Societe de Fabrication des Articles Pharmaceutiques SO.F.A.P Ltd</manufacturerName>
    <manufacturerSrn>TN-MF-000023623</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A0499</emdnCode>
    <emdnDescription>SOLUTION FILTERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AP01-124-00/SO</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-31T13:50:32.132Z</lastUpdated>
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  <row>
    <udiDi>06192493100153</udiDi>
    <basicUdiDi>61924931MPRCIST7</basicUdiDi>
    <tradeName>STERICUP</tradeName>
    <deviceName>Matériels de réduction des risques de contamination</deviceName>
    <manufacturerName>Societe de Fabrication des Articles Pharmaceutiques SO.F.A.P Ltd</manufacturerName>
    <manufacturerSrn>TN-MF-000023623</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A0499</emdnCode>
    <emdnDescription>SOLUTION FILTERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AP01-118-99/SO</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-31T13:50:31.333Z</lastUpdated>
  </row>
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