<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>06944270105208</udiDi>
    <basicUdiDi>69442701CrawlingType7B</basicUdiDi>
    <tradeName>06944270105208</tradeName>
    <deviceName>Steam Sterilization Chemical Indicator card (Crawling Type)</deviceName>
    <manufacturerName>Jiangmen New Era External Use Drug Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000036495</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>S9099</emdnCode>
    <emdnDescription>STERILISATION DEVICES (EXCLUDING CAT. D - Z) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Crawling Type</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-27T08:05:51.326Z</lastUpdated>
  </row>
  <row>
    <udiDi>06944270105116</udiDi>
    <basicUdiDi>69442701M322LN</basicUdiDi>
    <tradeName>06944270105116</tradeName>
    <deviceName>Vaporized Hydrogen Peroxide Indicator Label</deviceName>
    <manufacturerName>Jiangmen New Era External Use Drug Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000036495</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>S9099</emdnCode>
    <emdnDescription>STERILISATION DEVICES (EXCLUDING CAT. D - Z) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>M322</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-27T08:05:50.640Z</lastUpdated>
  </row>
  <row>
    <udiDi>06944270105109</udiDi>
    <basicUdiDi>69442701M311LH</basicUdiDi>
    <tradeName>06944270105109</tradeName>
    <deviceName>Vaporized Hydrogen Peroxide Indicator Tape</deviceName>
    <manufacturerName>Jiangmen New Era External Use Drug Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000036495</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>S9099</emdnCode>
    <emdnDescription>STERILISATION DEVICES (EXCLUDING CAT. D - Z) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>M311</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-27T08:05:50.463Z</lastUpdated>
  </row>
  <row>
    <udiDi>06944270105062</udiDi>
    <basicUdiDi>69442701M322LN</basicUdiDi>
    <tradeName>06944270105062</tradeName>
    <deviceName>Vaporized Hydrogen Peroxide Indicator Label</deviceName>
    <manufacturerName>Jiangmen New Era External Use Drug Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000036495</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>S9099</emdnCode>
    <emdnDescription>STERILISATION DEVICES (EXCLUDING CAT. D - Z) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>N/A</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-27T08:05:49.922Z</lastUpdated>
  </row>
  <row>
    <udiDi>06944270105055</udiDi>
    <basicUdiDi>69442701M322LN</basicUdiDi>
    <tradeName>06944270105055</tradeName>
    <deviceName>Vaporized Hydrogen Peroxide Indicator Label</deviceName>
    <manufacturerName>Jiangmen New Era External Use Drug Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000036495</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>S9099</emdnCode>
    <emdnDescription>STERILISATION DEVICES (EXCLUDING CAT. D - Z) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>N/A</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-27T08:05:42.627Z</lastUpdated>
  </row>
  <row>
    <udiDi>06944270105048</udiDi>
    <basicUdiDi>69442701M311LH</basicUdiDi>
    <tradeName>06944270105048</tradeName>
    <deviceName>Vaporized Hydrogen Peroxide Indicator Tape</deviceName>
    <manufacturerName>Jiangmen New Era External Use Drug Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000036495</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>S9099</emdnCode>
    <emdnDescription>STERILISATION DEVICES (EXCLUDING CAT. D - Z) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>N/A</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-27T08:05:40.493Z</lastUpdated>
  </row>
  <row>
    <udiDi>06944270105031</udiDi>
    <basicUdiDi>69442701YB01R8</basicUdiDi>
    <tradeName>06944270105031</tradeName>
    <deviceName>Sterilization Packing Material (Roll）</deviceName>
    <manufacturerName>Jiangmen New Era External Use Drug Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000036495</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>S01020102</emdnCode>
    <emdnDescription>STERILISATION REELS, GUSSETED, PAPER/PLASTIC FILM</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>N/A</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-27T08:05:38.387Z</lastUpdated>
  </row>
  <row>
    <udiDi>06944270105024</udiDi>
    <basicUdiDi>69442701YB01R8</basicUdiDi>
    <tradeName>06944270105024</tradeName>
    <deviceName>Sterilization Packing Material (Roll）</deviceName>
    <manufacturerName>Jiangmen New Era External Use Drug Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000036495</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>S01020102</emdnCode>
    <emdnDescription>STERILISATION REELS, GUSSETED, PAPER/PLASTIC FILM</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>N/A</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-27T08:05:37.383Z</lastUpdated>
  </row>
  <row>
    <udiDi>06944270105017</udiDi>
    <basicUdiDi>69442701YB01R8</basicUdiDi>
    <tradeName>06944270105017</tradeName>
    <deviceName>Sterilization Packing Material (Roll）</deviceName>
    <manufacturerName>Jiangmen New Era External Use Drug Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000036495</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>S01020101</emdnCode>
    <emdnDescription>FLAT STERILISATION REELS, PAPER/PLASTIC FILM</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>N/A</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-06-27T08:05:29.729Z</lastUpdated>
  </row>
  <row>
    <udiDi>06944270105000</udiDi>
    <basicUdiDi>69442701YB01R8</basicUdiDi>
    <tradeName>06944270105000</tradeName>
    <deviceName>Sterilization Packing Material (Roll）</deviceName>
    <manufacturerName>Jiangmen New Era External Use Drug Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000036495</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>S010299</emdnCode>
    <emdnDescription>STERILISATION REELS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Flat Reel</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-27T08:05:27.578Z</lastUpdated>
  </row>
  <row>
    <udiDi>06944270104379</udiDi>
    <basicUdiDi>69442701TTS01TR</basicUdiDi>
    <tradeName>06944270104379</tradeName>
    <deviceName>Cooling Gel Sheet</deviceName>
    <manufacturerName>Jiangmen New Era External Use Drug Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000036495</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>V9099</emdnCode>
    <emdnDescription>VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>N/A</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-27T08:05:26.696Z</lastUpdated>
  </row>
  <row>
    <udiDi>06944270104362</udiDi>
    <basicUdiDi>69442701TTS01TR</basicUdiDi>
    <tradeName>06944270104362</tradeName>
    <deviceName>Cooling Gel Sheet</deviceName>
    <manufacturerName>Jiangmen New Era External Use Drug Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000036495</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>V9099</emdnCode>
    <emdnDescription>VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>N/A</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-27T08:05:25.991Z</lastUpdated>
  </row>
  <row>
    <udiDi>06944270104355</udiDi>
    <basicUdiDi>69442701TTS01TR</basicUdiDi>
    <tradeName>06944270104355</tradeName>
    <deviceName>Cooling Gel Sheet</deviceName>
    <manufacturerName>Jiangmen New Era External Use Drug Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000036495</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>V9099</emdnCode>
    <emdnDescription>VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>N/A</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-27T08:05:19.166Z</lastUpdated>
  </row>
  <row>
    <udiDi>06944270104348</udiDi>
    <basicUdiDi>69442701TTS01TR</basicUdiDi>
    <tradeName>06944270104348</tradeName>
    <deviceName>Cooling Gel Sheet</deviceName>
    <manufacturerName>Jiangmen New Era External Use Drug Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000036495</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>V9099</emdnCode>
    <emdnDescription>VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>N/A</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-27T08:05:18.224Z</lastUpdated>
  </row>
  <row>
    <udiDi>06944270104331</udiDi>
    <basicUdiDi>69442701TTS01TR</basicUdiDi>
    <tradeName>06944270104331</tradeName>
    <deviceName>Cooling Gel Sheet</deviceName>
    <manufacturerName>Jiangmen New Era External Use Drug Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000036495</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>V9099</emdnCode>
    <emdnDescription>VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>120mm*50mm</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-27T08:05:16.807Z</lastUpdated>
  </row>
  <row>
    <udiDi>06944270104324</udiDi>
    <basicUdiDi>69442701M111L7</basicUdiDi>
    <tradeName>06944270104324</tradeName>
    <deviceName>Autoclave Indicator Tape</deviceName>
    <manufacturerName>Jiangmen New Era External Use Drug Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000036495</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>S9099</emdnCode>
    <emdnDescription>STERILISATION DEVICES (EXCLUDING CAT. D - Z) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>N/A</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-27T08:05:15.891Z</lastUpdated>
  </row>
  <row>
    <udiDi>06944270104317</udiDi>
    <basicUdiDi>69442701M111L7</basicUdiDi>
    <tradeName>06944270104317</tradeName>
    <deviceName>Autoclave Indicator Tape</deviceName>
    <manufacturerName>Jiangmen New Era External Use Drug Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000036495</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>S9099</emdnCode>
    <emdnDescription>STERILISATION DEVICES (EXCLUDING CAT. D - Z) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>N/A</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-27T08:05:09.553Z</lastUpdated>
  </row>
  <row>
    <udiDi>06944270104300</udiDi>
    <basicUdiDi>69442701M111L7</basicUdiDi>
    <tradeName>06944270104300</tradeName>
    <deviceName>Autoclave Indicator Tape</deviceName>
    <manufacturerName>Jiangmen New Era External Use Drug Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000036495</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>S9099</emdnCode>
    <emdnDescription>STERILISATION DEVICES (EXCLUDING CAT. D - Z) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>N/A</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-27T08:05:08.402Z</lastUpdated>
  </row>
  <row>
    <udiDi>06944270104294</udiDi>
    <basicUdiDi>69442701M111L7</basicUdiDi>
    <tradeName>06944270104294</tradeName>
    <deviceName>Autoclave Indicator Tape</deviceName>
    <manufacturerName>Jiangmen New Era External Use Drug Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000036495</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>S9099</emdnCode>
    <emdnDescription>STERILISATION DEVICES (EXCLUDING CAT. D - Z) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>N/A</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-27T08:05:07.149Z</lastUpdated>
  </row>
  <row>
    <udiDi>06944270104287</udiDi>
    <basicUdiDi>69442701M111L7</basicUdiDi>
    <tradeName>06944270104287</tradeName>
    <deviceName>Autoclave Indicator Tape</deviceName>
    <manufacturerName>Jiangmen New Era External Use Drug Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000036495</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>S9099</emdnCode>
    <emdnDescription>STERILISATION DEVICES (EXCLUDING CAT. D - Z) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>N/A</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-27T08:05:06.036Z</lastUpdated>
  </row>
</eudamedExport>