<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>05907996813131</udiDi>
    <basicUdiDi>B-05907996813131</basicUdiDi>
    <tradeName>omegapack Zestaw chirurgiczny 64 - NACZYNIOWY DUŻY</tradeName>
    <deviceName>omegapack Zestaw chirurgiczny 64 - NACZYNIOWY DUŻY</deviceName>
    <manufacturerName>ZARYS International Spółka z ograniczoną odpowiedzialnością</manufacturerName>
    <manufacturerSrn>PL-MF-000000410</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>V0599</emdnCode>
    <emdnDescription>CLINICAL PROCEDURES KITS NOT INCLUDED IN OTHER CLASSES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OP-CHI-00564</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-06T06:21:13.577Z</lastUpdated>
  </row>
  <row>
    <udiDi>05907996813117</udiDi>
    <basicUdiDi>B-05907996813117</basicUdiDi>
    <tradeName>omegapack Zestaw chirurgiczny 63 - MAŁY</tradeName>
    <deviceName>omegapack Zestaw chirurgiczny 63 - MAŁY</deviceName>
    <manufacturerName>ZARYS International Spółka z ograniczoną odpowiedzialnością</manufacturerName>
    <manufacturerSrn>PL-MF-000000410</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>V0599</emdnCode>
    <emdnDescription>CLINICAL PROCEDURES KITS NOT INCLUDED IN OTHER CLASSES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OP-CHI-00563</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-06T06:21:12.746Z</lastUpdated>
  </row>
  <row>
    <udiDi>05907996811823</udiDi>
    <basicUdiDi>B-05907996811823</basicUdiDi>
    <tradeName>omegapack Zestaw chirurgiczny 27</tradeName>
    <deviceName>omegapack Zestaw chirurgiczny 27</deviceName>
    <manufacturerName>ZARYS International Spółka z ograniczoną odpowiedzialnością</manufacturerName>
    <manufacturerSrn>PL-MF-000000410</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>V0599</emdnCode>
    <emdnDescription>CLINICAL PROCEDURES KITS NOT INCLUDED IN OTHER CLASSES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OP-CHI-00527</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-06T06:21:11.944Z</lastUpdated>
  </row>
  <row>
    <udiDi>05907996805877</udiDi>
    <basicUdiDi>B-05907996805877</basicUdiDi>
    <tradeName>omegapack Zestaw do operacji kardiochirurgicznych 18</tradeName>
    <deviceName>omegapack Zestaw do operacji kardiochirurgicznych 18</deviceName>
    <manufacturerName>ZARYS International Spółka z ograniczoną odpowiedzialnością</manufacturerName>
    <manufacturerSrn>PL-MF-000000410</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>V0599</emdnCode>
    <emdnDescription>CLINICAL PROCEDURES KITS NOT INCLUDED IN OTHER CLASSES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OP-KAR-01518</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-06T06:21:07.940Z</lastUpdated>
  </row>
  <row>
    <udiDi>05904109618089</udiDi>
    <basicUdiDi>B-05904109618089</basicUdiDi>
    <tradeName>omegapack Zestaw chirurgiczny 62</tradeName>
    <deviceName>omegapack Zestaw chirurgiczny 62</deviceName>
    <manufacturerName>ZARYS International Spółka z ograniczoną odpowiedzialnością</manufacturerName>
    <manufacturerSrn>PL-MF-000000410</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>V0599</emdnCode>
    <emdnDescription>CLINICAL PROCEDURES KITS NOT INCLUDED IN OTHER CLASSES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OP-CHI-00562</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-06T06:19:51.843Z</lastUpdated>
  </row>
  <row>
    <udiDi>05904109618126</udiDi>
    <basicUdiDi>B-05904109618126</basicUdiDi>
    <tradeName>deltaset Pakiet do cewnikowania 49</tradeName>
    <deviceName>deltaset Pakiet do cewnikowania 49</deviceName>
    <manufacturerName>ZARYS International Spółka z ograniczoną odpowiedzialnością</manufacturerName>
    <manufacturerSrn>PL-MF-000000410</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>V0599</emdnCode>
    <emdnDescription>CLINICAL PROCEDURES KITS NOT INCLUDED IN OTHER CLASSES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DS-CEW-00049</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-06T06:19:50.244Z</lastUpdated>
  </row>
  <row>
    <udiDi>05904109618102</udiDi>
    <basicUdiDi>B-05904109618102</basicUdiDi>
    <tradeName>omegapack Zestaw do operacji otolaryngologicznych 61</tradeName>
    <deviceName>omegapack Zestaw do operacji otolaryngologicznych 61</deviceName>
    <manufacturerName>ZARYS International Spółka z ograniczoną odpowiedzialnością</manufacturerName>
    <manufacturerSrn>PL-MF-000000410</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>V0599</emdnCode>
    <emdnDescription>CLINICAL PROCEDURES KITS NOT INCLUDED IN OTHER CLASSES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OP-OTO-03811</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-06T06:19:49.641Z</lastUpdated>
  </row>
  <row>
    <udiDi>05904109618003</udiDi>
    <basicUdiDi>B-05904109618003</basicUdiDi>
    <tradeName>omegapack Zestaw do operacji ortopedycznych 563 - ENDOPROTEZA BIODRA</tradeName>
    <deviceName>omegapack Zestaw do operacji ortopedycznych 563 - ENDOPROTEZA BIODRA</deviceName>
    <manufacturerName>ZARYS International Spółka z ograniczoną odpowiedzialnością</manufacturerName>
    <manufacturerSrn>PL-MF-000000410</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>V0599</emdnCode>
    <emdnDescription>CLINICAL PROCEDURES KITS NOT INCLUDED IN OTHER CLASSES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OP-ORT-01463</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-06T06:19:48.405Z</lastUpdated>
  </row>
  <row>
    <udiDi>05904109617983</udiDi>
    <basicUdiDi>B-05904109617983</basicUdiDi>
    <tradeName>deltaset Pakiet do znieczuleń 144</tradeName>
    <deviceName>deltaset Pakiet do znieczuleń 144</deviceName>
    <manufacturerName>ZARYS International Spółka z ograniczoną odpowiedzialnością</manufacturerName>
    <manufacturerSrn>PL-MF-000000410</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>V0599</emdnCode>
    <emdnDescription>CLINICAL PROCEDURES KITS NOT INCLUDED IN OTHER CLASSES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DS-ZNI-00744</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-06T06:19:32.579Z</lastUpdated>
  </row>
  <row>
    <udiDi>05904109616641</udiDi>
    <basicUdiDi>B-05904109616641</basicUdiDi>
    <tradeName>omegapack Zestaw do operacji kardiochirurgicznych 80</tradeName>
    <deviceName>omegapack Zestaw do operacji kardiochirurgicznych 80</deviceName>
    <manufacturerName>ZARYS International Spółka z ograniczoną odpowiedzialnością</manufacturerName>
    <manufacturerSrn>PL-MF-000000410</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>V0599</emdnCode>
    <emdnDescription>CLINICAL PROCEDURES KITS NOT INCLUDED IN OTHER CLASSES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OP-KAR-01580</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-06T06:19:31.785Z</lastUpdated>
  </row>
  <row>
    <udiDi>05904109616467</udiDi>
    <basicUdiDi>B-05904109616467</basicUdiDi>
    <tradeName>deltaset Pakiet uniwersalny 348 - PORODOWY</tradeName>
    <deviceName>deltaset Pakiet uniwersalny 348 - PORODOWY</deviceName>
    <manufacturerName>ZARYS International Spółka z ograniczoną odpowiedzialnością</manufacturerName>
    <manufacturerSrn>PL-MF-000000410</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>V0599</emdnCode>
    <emdnDescription>CLINICAL PROCEDURES KITS NOT INCLUDED IN OTHER CLASSES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DS-UNI-01048</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-06T06:19:30.979Z</lastUpdated>
  </row>
  <row>
    <udiDi>05904109616443</udiDi>
    <basicUdiDi>B-05904109616443</basicUdiDi>
    <tradeName>deltaset Pakiet uniwersalny 186 - PORODOWY</tradeName>
    <deviceName>deltaset Pakiet uniwersalny 186 - PORODOWY</deviceName>
    <manufacturerName>ZARYS International Spółka z ograniczoną odpowiedzialnością</manufacturerName>
    <manufacturerSrn>PL-MF-000000410</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>V0599</emdnCode>
    <emdnDescription>CLINICAL PROCEDURES KITS NOT INCLUDED IN OTHER CLASSES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DS-UNI-00886</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-06T06:19:26.981Z</lastUpdated>
  </row>
  <row>
    <udiDi>05904109616429</udiDi>
    <basicUdiDi>B-05904109616429</basicUdiDi>
    <tradeName>deltaset Pakiet do znieczuleń 142</tradeName>
    <deviceName>deltaset Pakiet do znieczuleń 142</deviceName>
    <manufacturerName>ZARYS International Spółka z ograniczoną odpowiedzialnością</manufacturerName>
    <manufacturerSrn>PL-MF-000000410</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>V0599</emdnCode>
    <emdnDescription>CLINICAL PROCEDURES KITS NOT INCLUDED IN OTHER CLASSES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DS-ZNI-00742</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-06T06:19:26.175Z</lastUpdated>
  </row>
  <row>
    <udiDi>05904109616405</udiDi>
    <basicUdiDi>B-05904109616405</basicUdiDi>
    <tradeName>omegapack Zestaw do laparoskopii 88</tradeName>
    <deviceName>omegapack Zestaw do laparoskopii 88</deviceName>
    <manufacturerName>ZARYS International Spółka z ograniczoną odpowiedzialnością</manufacturerName>
    <manufacturerSrn>PL-MF-000000410</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>V0599</emdnCode>
    <emdnDescription>CLINICAL PROCEDURES KITS NOT INCLUDED IN OTHER CLASSES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OP-LAP-00888</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-06T06:19:25.374Z</lastUpdated>
  </row>
  <row>
    <udiDi>05904109616382</udiDi>
    <basicUdiDi>B-05904109616382</basicUdiDi>
    <tradeName>omegapack Zestaw do operacji ortopedycznych 403 - BIODRO</tradeName>
    <deviceName>omegapack Zestaw do operacji ortopedycznych 403 - BIODRO</deviceName>
    <manufacturerName>ZARYS International Spółka z ograniczoną odpowiedzialnością</manufacturerName>
    <manufacturerSrn>PL-MF-000000410</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>V0599</emdnCode>
    <emdnDescription>CLINICAL PROCEDURES KITS NOT INCLUDED IN OTHER CLASSES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OP-ORT-01403</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-06T06:19:24.577Z</lastUpdated>
  </row>
  <row>
    <udiDi>05904109616023</udiDi>
    <basicUdiDi>B-05904109616023</basicUdiDi>
    <tradeName>omegapack Zestaw do laparoskopii 106</tradeName>
    <deviceName>omegapack Zestaw do laparoskopii 106</deviceName>
    <manufacturerName>ZARYS International Spółka z ograniczoną odpowiedzialnością</manufacturerName>
    <manufacturerSrn>PL-MF-000000410</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>V0599</emdnCode>
    <emdnDescription>CLINICAL PROCEDURES KITS NOT INCLUDED IN OTHER CLASSES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OP-LAP-00906</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-06T06:19:20.568Z</lastUpdated>
  </row>
  <row>
    <udiDi>05904109616009</udiDi>
    <basicUdiDi>B-05904109616009</basicUdiDi>
    <tradeName>omegapack Zestaw do operacji kardiochirurgicznych 79 - STYMULATORY SERCA</tradeName>
    <deviceName>omegapack Zestaw do operacji kardiochirurgicznych 79 - STYMULATORY SERCA</deviceName>
    <manufacturerName>ZARYS International Spółka z ograniczoną odpowiedzialnością</manufacturerName>
    <manufacturerSrn>PL-MF-000000410</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>V0599</emdnCode>
    <emdnDescription>CLINICAL PROCEDURES KITS NOT INCLUDED IN OTHER CLASSES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OP-KAR-01579</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-06T06:19:19.771Z</lastUpdated>
  </row>
  <row>
    <udiDi>05904109615965</udiDi>
    <basicUdiDi>B-05904109615965</basicUdiDi>
    <tradeName>deltaset Pakiet noworodkowy I-9</tradeName>
    <deviceName>deltaset Pakiet noworodkowy I-9</deviceName>
    <manufacturerName>ZARYS International Spółka z ograniczoną odpowiedzialnością</manufacturerName>
    <manufacturerSrn>PL-MF-000000410</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>V0599</emdnCode>
    <emdnDescription>CLINICAL PROCEDURES KITS NOT INCLUDED IN OTHER CLASSES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DS-NOW-I-009</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-06T06:19:18.972Z</lastUpdated>
  </row>
  <row>
    <udiDi>05904109615613</udiDi>
    <basicUdiDi>B-05904109615613</basicUdiDi>
    <tradeName>deltaset Pakiet do znieczuleń 146</tradeName>
    <deviceName>deltaset Pakiet do znieczuleń 146</deviceName>
    <manufacturerName>ZARYS International Spółka z ograniczoną odpowiedzialnością</manufacturerName>
    <manufacturerSrn>PL-MF-000000410</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>V0599</emdnCode>
    <emdnDescription>CLINICAL PROCEDURES KITS NOT INCLUDED IN OTHER CLASSES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DS-ZNI-00746</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-06T06:19:18.167Z</lastUpdated>
  </row>
  <row>
    <udiDi>05904109615590</udiDi>
    <basicUdiDi>B-05904109615590</basicUdiDi>
    <tradeName>deltaset Pakiet do znieczuleń 145</tradeName>
    <deviceName>deltaset Pakiet do znieczuleń 145</deviceName>
    <manufacturerName>ZARYS International Spółka z ograniczoną odpowiedzialnością</manufacturerName>
    <manufacturerSrn>PL-MF-000000410</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>V0599</emdnCode>
    <emdnDescription>CLINICAL PROCEDURES KITS NOT INCLUDED IN OTHER CLASSES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DS-ZNI-00745</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-06T06:19:14.167Z</lastUpdated>
  </row>
</eudamedExport>