<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>04719961300017</udiDi>
    <basicUdiDi>471996130OPALHK4</basicUdiDi>
    <tradeName>OPAL</tradeName>
    <deviceName>“Inti” Oocyte Holding Device (Non-Sterile)</deviceName>
    <manufacturerName>Inti Taiwan, Inc.</manufacturerName>
    <manufacturerSrn>TW-MF-000048831</manufacturerSrn>
    <authorisedRepresentativeName>Luana Med. B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002750</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12080202</emdnCode>
    <emdnDescription>OOCYTE ASPIRATION EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OPAL H1</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-31T03:52:59.500Z</lastUpdated>
  </row>
  <row>
    <udiDi>00819374025607</udiDi>
    <basicUdiDi>081226101OPN058UV</basicUdiDi>
    <tradeName>FALCON Single Lumen Ovum Pickup Needle</tradeName>
    <deviceName>OVUM PICKUP NEEDLE</deviceName>
    <manufacturerName>Allwin Medical Devices, Inc</manufacturerName>
    <manufacturerSrn>US-MF-000011349</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12080202</emdnCode>
    <emdnDescription>OOCYTE ASPIRATION EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>F-OVM-SL17/35</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-29T23:34:47.598Z</lastUpdated>
  </row>
  <row>
    <udiDi>00819374027236</udiDi>
    <basicUdiDi>081226101OPN058UV</basicUdiDi>
    <tradeName>OPICK Single Lumen Ovum Pickup Needle with Knurling</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Allwin Medical Devices, Inc</manufacturerName>
    <manufacturerSrn>US-MF-000011349</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12080202</emdnCode>
    <emdnDescription>OOCYTE ASPIRATION EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OPN-SL17/35-K</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-29T19:54:39.578Z</lastUpdated>
  </row>
  <row>
    <udiDi>04719961300048</udiDi>
    <basicUdiDi>471996130OPALHK4</basicUdiDi>
    <tradeName>Opal</tradeName>
    <deviceName>“Inti” Oocyte Holding Device (Non-Sterile)</deviceName>
    <manufacturerName>Inti Taiwan, Inc.</manufacturerName>
    <manufacturerSrn>TW-MF-000048831</manufacturerSrn>
    <authorisedRepresentativeName>Luana Med. B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002750</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12080202</emdnCode>
    <emdnDescription>OOCYTE ASPIRATION EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Opal H2</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-16T06:35:44.817Z</lastUpdated>
  </row>
  <row>
    <udiDi>00812261016535</udiDi>
    <basicUdiDi>081226101OPN058UV</basicUdiDi>
    <tradeName>OVUMPICK Ovum Pickup Needle</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Allwin Medical Devices, Inc</manufacturerName>
    <manufacturerSrn>US-MF-000011349</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12080202</emdnCode>
    <emdnDescription>OOCYTE ASPIRATION EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OVM-DL16/35</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-16T01:11:50.424Z</lastUpdated>
  </row>
  <row>
    <udiDi>00827002492752</udiDi>
    <basicUdiDi>B-00827002492752</basicUdiDi>
    <tradeName>00827002492752</tradeName>
    <deviceName>Vacuum Pump</deviceName>
    <manufacturerName>William A. Cook Australia Pty. Ltd.</manufacturerName>
    <manufacturerSrn>AU-MF-000002276</manufacturerSrn>
    <authorisedRepresentativeName>COOK MEDICAL EUROPE LIMITED</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000907</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12080202</emdnCode>
    <emdnDescription>OOCYTE ASPIRATION EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>K-MAR-5200</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-04T19:45:26.470Z</lastUpdated>
  </row>
  <row>
    <udiDi>00819374020589</udiDi>
    <basicUdiDi>081226101OPN058UV</basicUdiDi>
    <tradeName>ACE Ovum Pickup Needle</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Allwin Medical Devices, Inc</manufacturerName>
    <manufacturerSrn>US-MF-000011349</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12080202</emdnCode>
    <emdnDescription>OOCYTE ASPIRATION EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A-OVM-SL17/35-FL</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T05:14:14.361Z</lastUpdated>
  </row>
  <row>
    <udiDi>00819374021777</udiDi>
    <basicUdiDi>081226101OPN058UV</basicUdiDi>
    <tradeName>ACE Ovum Pickup Needle</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Allwin Medical Devices, Inc</manufacturerName>
    <manufacturerSrn>US-MF-000011349</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12080202</emdnCode>
    <emdnDescription>OOCYTE ASPIRATION EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A-OVM-SL16/35-FL</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T05:14:13.971Z</lastUpdated>
  </row>
  <row>
    <udiDi>00819374021821</udiDi>
    <basicUdiDi>081226101OPN058UV</basicUdiDi>
    <tradeName>ACE Ovum Pickup Needle</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Allwin Medical Devices, Inc</manufacturerName>
    <manufacturerSrn>US-MF-000011349</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12080202</emdnCode>
    <emdnDescription>OOCYTE ASPIRATION EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A-OVM-SL18/35-FL</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T05:14:13.934Z</lastUpdated>
  </row>
  <row>
    <udiDi>00819374021845</udiDi>
    <basicUdiDi>081226101OPN058UV</basicUdiDi>
    <tradeName>OVUMPICK Ovum Pickup Needle</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Allwin Medical Devices, Inc</manufacturerName>
    <manufacturerSrn>US-MF-000011349</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12080202</emdnCode>
    <emdnDescription>OOCYTE ASPIRATION EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OVM-DL17/35</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T05:14:13.913Z</lastUpdated>
  </row>
  <row>
    <udiDi>00819374021906</udiDi>
    <basicUdiDi>081226101OPN058UV</basicUdiDi>
    <tradeName>ACE Ovum Pickup Needle</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Allwin Medical Devices, Inc</manufacturerName>
    <manufacturerSrn>US-MF-000011349</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12080202</emdnCode>
    <emdnDescription>OOCYTE ASPIRATION EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A-OVM-SL17/35-M</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T05:14:13.861Z</lastUpdated>
  </row>
  <row>
    <udiDi>00819374022460</udiDi>
    <basicUdiDi>081226101OPN058UV</basicUdiDi>
    <tradeName>ACE Ovum Pickup Needle</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Allwin Medical Devices, Inc</manufacturerName>
    <manufacturerSrn>US-MF-000011349</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12080202</emdnCode>
    <emdnDescription>OOCYTE ASPIRATION EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A-OVM-SL16/35</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T05:14:13.713Z</lastUpdated>
  </row>
  <row>
    <udiDi>00819374022477</udiDi>
    <basicUdiDi>081226101OPN058UV</basicUdiDi>
    <tradeName>ACE Ovum Pickup Needle</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Allwin Medical Devices, Inc</manufacturerName>
    <manufacturerSrn>US-MF-000011349</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12080202</emdnCode>
    <emdnDescription>OOCYTE ASPIRATION EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A-OVM-SL16/35-M</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T05:14:13.692Z</lastUpdated>
  </row>
  <row>
    <udiDi>00819374022484</udiDi>
    <basicUdiDi>081226101OPN058UV</basicUdiDi>
    <tradeName>ACE Ovum Pickup Needle</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Allwin Medical Devices, Inc</manufacturerName>
    <manufacturerSrn>US-MF-000011349</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12080202</emdnCode>
    <emdnDescription>OOCYTE ASPIRATION EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A-OVM-SL18/35-M</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T05:14:13.672Z</lastUpdated>
  </row>
  <row>
    <udiDi>00819374022545</udiDi>
    <basicUdiDi>081226101OPN058UV</basicUdiDi>
    <tradeName>ACE Ovum Pickup Needle</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Allwin Medical Devices, Inc</manufacturerName>
    <manufacturerSrn>US-MF-000011349</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12080202</emdnCode>
    <emdnDescription>OOCYTE ASPIRATION EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A-OVM-SL18/35</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T05:14:13.626Z</lastUpdated>
  </row>
  <row>
    <udiDi>00819374024877</udiDi>
    <basicUdiDi>081226101OPN058UV</basicUdiDi>
    <tradeName>EAGLE Ovum Pickup Needle</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Allwin Medical Devices, Inc</manufacturerName>
    <manufacturerSrn>US-MF-000011349</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12080202</emdnCode>
    <emdnDescription>OOCYTE ASPIRATION EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>E-OVM-SL17/35</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T05:14:13.246Z</lastUpdated>
  </row>
  <row>
    <udiDi>00819374027991</udiDi>
    <basicUdiDi>081226101OPN058UV</basicUdiDi>
    <tradeName>EAGLE Ovum Pickup Needle</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Allwin Medical Devices, Inc</manufacturerName>
    <manufacturerSrn>US-MF-000011349</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12080202</emdnCode>
    <emdnDescription>OOCYTE ASPIRATION EQUIPMENT</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-06T18:48:36.824Z</lastUpdated>
  </row>
  <row>
    <udiDi>00819374027984</udiDi>
    <basicUdiDi>081226101OPN058UV</basicUdiDi>
    <tradeName>EAGLE Ovum Pickup Needle</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Allwin Medical Devices, Inc</manufacturerName>
    <manufacturerSrn>US-MF-000011349</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12080202</emdnCode>
    <emdnDescription>OOCYTE ASPIRATION EQUIPMENT</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-06T18:48:35.726Z</lastUpdated>
  </row>
  <row>
    <udiDi>00819374027977</udiDi>
    <basicUdiDi>081226101OPN058UV</basicUdiDi>
    <tradeName>EAGLE Ovum Pickup Needle</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Allwin Medical Devices, Inc</manufacturerName>
    <manufacturerSrn>US-MF-000011349</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12080202</emdnCode>
    <emdnDescription>OOCYTE ASPIRATION EQUIPMENT</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-06T18:48:34.632Z</lastUpdated>
  </row>
  <row>
    <udiDi>00819374027960</udiDi>
    <basicUdiDi>081226101OPN058UV</basicUdiDi>
    <tradeName>EAGLE Ovum Pickup Needle</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Allwin Medical Devices, Inc</manufacturerName>
    <manufacturerSrn>US-MF-000011349</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12080202</emdnCode>
    <emdnDescription>OOCYTE ASPIRATION EQUIPMENT</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-06T18:48:33.516Z</lastUpdated>
  </row>
</eudamedExport>