<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>06975394402010</udiDi>
    <basicUdiDi>697539440LYHC00UD</basicUdiDi>
    <tradeName>HANDCUFF</tradeName>
    <deviceName>HANDCUFF</deviceName>
    <manufacturerName>LINYE HEALTH TECH(NINGBO)CO.,LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000024232</manufacturerSrn>
    <authorisedRepresentativeName>Sungo Cert GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000010869</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>M03030299</emdnCode>
    <emdnDescription>PROTECTION SYSTEMS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LY-HC01/EDHA10246</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T15:54:06.246Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975394401990</udiDi>
    <basicUdiDi>697539440LYFS00WF</basicUdiDi>
    <tradeName>DISPOSABLE FACE SHIELD</tradeName>
    <deviceName>Disposable Face shield</deviceName>
    <manufacturerName>LINYE HEALTH TECH(NINGBO)CO.,LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000024232</manufacturerSrn>
    <authorisedRepresentativeName>Sungo Cert GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000010869</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>T0399</emdnCode>
    <emdnDescription>PROTECTION DEVICES (EXCLUDING PERSONAL PROTECTIVE EQUIPMENT PPE) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EDHA10247 / LY-FS01</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T15:54:02.245Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975394401952</udiDi>
    <basicUdiDi>697539440LYTP00Z2</basicUdiDi>
    <tradeName>DISTALSCHUTZ</tradeName>
    <deviceName>DISTAL TIP PROTECTOR</deviceName>
    <manufacturerName>LINYE HEALTH TECH(NINGBO)CO.,LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000024232</manufacturerSrn>
    <authorisedRepresentativeName>Sungo Cert GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000010869</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>T030199</emdnCode>
    <emdnDescription>COVERS, INSTRUMENTS AND EQUIPMENT - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EDHA825111</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T15:54:01.447Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975394401778</udiDi>
    <basicUdiDi>697539440LYMH00W9</basicUdiDi>
    <tradeName>Inhalator</tradeName>
    <deviceName>Inhaler</deviceName>
    <manufacturerName>LINYE HEALTH TECH(NINGBO)CO.,LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000024232</manufacturerSrn>
    <authorisedRepresentativeName>Sungo Cert GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000010869</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R900901</emdnCode>
    <emdnDescription>INHALERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LY-MH01</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-02T15:54:00.643Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975394401624</udiDi>
    <basicUdiDi>697539440LYET00WD</basicUdiDi>
    <tradeName>KLYSO</tradeName>
    <deviceName>MEDICAL ENEMATOR</deviceName>
    <manufacturerName>LINYE HEALTH TECH(NINGBO)CO.,LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000024232</manufacturerSrn>
    <authorisedRepresentativeName>Sungo Cert GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000010869</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>G02060303</emdnCode>
    <emdnDescription>BALLOON CATHETERS, BARIUM ENEMA</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>61001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T15:53:59.939Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975394401563</udiDi>
    <basicUdiDi>697539440LYBC00T3</basicUdiDi>
    <tradeName>MATRESS COVER</tradeName>
    <deviceName>MATRESS COVER</deviceName>
    <manufacturerName>LINYE HEALTH TECH(NINGBO)CO.,LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000024232</manufacturerSrn>
    <authorisedRepresentativeName>Sungo Cert GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000010869</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>T030502</emdnCode>
    <emdnDescription>BED AND STRETCHER HYGIENIC COVERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LY-BC01</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T15:53:43.780Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975394401464</udiDi>
    <basicUdiDi>697539440LYDP00VJ</basicUdiDi>
    <tradeName>MEDICAL PANTS</tradeName>
    <deviceName>MEDICAL PANTS</deviceName>
    <manufacturerName>LINYE HEALTH TECH(NINGBO)CO.,LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000024232</manufacturerSrn>
    <authorisedRepresentativeName>Sungo Cert GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000010869</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>T0299</emdnCode>
    <emdnDescription>PROTECTION DRAPES AND GARMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LY-DP01/EDHA83002</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T15:53:42.977Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975394401457</udiDi>
    <basicUdiDi>697539440LYSC00WS</basicUdiDi>
    <tradeName>SHOE COVER</tradeName>
    <deviceName>SHOE COVER</deviceName>
    <manufacturerName>LINYE HEALTH TECH(NINGBO)CO.,LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000024232</manufacturerSrn>
    <authorisedRepresentativeName>Sungo Cert GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000010869</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>T0208</emdnCode>
    <emdnDescription>SHOE COVERS (EXCLUDING PERSONAL PROTECTIVE EQUIPMENT - PPE)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LY-SC01</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T15:53:39.091Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975394401365</udiDi>
    <basicUdiDi>697539440LYBT00VQ</basicUdiDi>
    <tradeName>BREATHING TRAINER</tradeName>
    <deviceName>BREATHING TRAINER</deviceName>
    <manufacturerName>LINYE HEALTH TECH(NINGBO)CO.,LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000024232</manufacturerSrn>
    <authorisedRepresentativeName>Sungo Cert GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000010869</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>R900902</emdnCode>
    <emdnDescription>INSPIRATORY AND EXPIRATORY FLOW STIMULATORS/RESPIRATORY MUSCLES TRAINERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LY-BT01</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T15:53:37.380Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975394401280</udiDi>
    <basicUdiDi>697539440LYMB00VB</basicUdiDi>
    <tradeName>MEDICAL BOWL</tradeName>
    <deviceName>MEDICAL BOWL</deviceName>
    <manufacturerName>LINYE HEALTH TECH(NINGBO)CO.,LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000024232</manufacturerSrn>
    <authorisedRepresentativeName>Sungo Cert GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000010869</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>V0402</emdnCode>
    <emdnDescription>CLINICAL USE TRAYS AND BOWLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LY-MB01</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T15:53:36.570Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975394401181</udiDi>
    <basicUdiDi>697539440LYBP00V4</basicUdiDi>
    <tradeName>Bedpan</tradeName>
    <deviceName>Bedpan</deviceName>
    <manufacturerName>LINYE HEALTH TECH(NINGBO)CO.,LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000024232</manufacturerSrn>
    <authorisedRepresentativeName>Sungo Cert GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000010869</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>T0499</emdnCode>
    <emdnDescription>INCONTINENCE DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LY-BP01</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T15:53:35.771Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975394401129</udiDi>
    <basicUdiDi>697539440LYIS00X4</basicUdiDi>
    <tradeName>Infusion stand</tradeName>
    <deviceName>Infusion stand</deviceName>
    <manufacturerName>LINYE HEALTH TECH(NINGBO)CO.,LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000024232</manufacturerSrn>
    <authorisedRepresentativeName>Sungo Cert GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000010869</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>LY-IS02</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T15:53:31.777Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975394400962</udiDi>
    <basicUdiDi>697539440LYIG00V8</basicUdiDi>
    <tradeName>Isolation gown</tradeName>
    <deviceName>Isolation gown</deviceName>
    <manufacturerName>LINYE HEALTH TECH(NINGBO)CO.,LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000024232</manufacturerSrn>
    <authorisedRepresentativeName>Sungo Cert GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000010869</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>T0299</emdnCode>
    <emdnDescription>PROTECTION DRAPES AND GARMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EDHA41002 / LY-IG01</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T15:53:30.970Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975394400801</udiDi>
    <basicUdiDi>697539440LYOS00YE</basicUdiDi>
    <tradeName>ORAL SWAB</tradeName>
    <deviceName>ORAL SWAB</deviceName>
    <manufacturerName>LINYE HEALTH TECH(NINGBO)CO.,LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000024232</manufacturerSrn>
    <authorisedRepresentativeName>Sungo Cert GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000010869</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q0199</emdnCode>
    <emdnDescription>ODONTOLOGY DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LY-OS01</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T15:53:30.171Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975394400566</udiDi>
    <basicUdiDi>697539440LYMP00XH</basicUdiDi>
    <tradeName>Medical cushion</tradeName>
    <deviceName>Medical cushion</deviceName>
    <manufacturerName>LINYE HEALTH TECH(NINGBO)CO.,LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000024232</manufacturerSrn>
    <authorisedRepresentativeName>Sungo Cert GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000010869</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>LY-MP03/40101</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T15:53:29.365Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975394400481</udiDi>
    <basicUdiDi>697539440LYMC00VG</basicUdiDi>
    <tradeName>Medical Comb</tradeName>
    <deviceName>Medical Comb</deviceName>
    <manufacturerName>LINYE HEALTH TECH(NINGBO)CO.,LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000024232</manufacturerSrn>
    <authorisedRepresentativeName>Sungo Cert GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000010869</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>LY-MC01</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T15:53:25.371Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975394400436</udiDi>
    <basicUdiDi>697539440LYEC00TQ</basicUdiDi>
    <tradeName>MEDICAL EYE BATH CUP</tradeName>
    <deviceName>MEDICAL EYE BATH CUP</deviceName>
    <manufacturerName>LINYE HEALTH TECH(NINGBO)CO.,LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000024232</manufacturerSrn>
    <authorisedRepresentativeName>Sungo Cert GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000010869</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q0299</emdnCode>
    <emdnDescription>OPHTHALMIC DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>type 3</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T15:53:24.958Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975394400399</udiDi>
    <basicUdiDi>697539440LYEB00TK</basicUdiDi>
    <tradeName>EAR BANDAGE</tradeName>
    <deviceName>EAR BANDAGE</deviceName>
    <manufacturerName>LINYE HEALTH TECH(NINGBO)CO.,LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000024232</manufacturerSrn>
    <authorisedRepresentativeName>Sungo Cert GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000010869</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>M0399</emdnCode>
    <emdnDescription>BANDAGES - OTHER (see Y06 for collars, tutors, etc.)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>37000 / LY-EB02</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T15:53:23.868Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975394400283</udiDi>
    <basicUdiDi>697539440LYEM00VA</basicUdiDi>
    <tradeName>EYE MASK</tradeName>
    <deviceName>EYE MASK</deviceName>
    <manufacturerName>LINYE HEALTH TECH(NINGBO)CO.,LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000024232</manufacturerSrn>
    <authorisedRepresentativeName>Sungo Cert GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000010869</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>M040399</emdnCode>
    <emdnDescription>OPHTHALMIC DRESSINGS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>type 3</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-02T15:53:22.169Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975394400238</udiDi>
    <basicUdiDi>697539440LYAS00VC</basicUdiDi>
    <tradeName>ARM STRAP</tradeName>
    <deviceName>ARM STRAP</deviceName>
    <manufacturerName>LINYE HEALTH TECH(NINGBO)CO.,LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000024232</manufacturerSrn>
    <authorisedRepresentativeName>Sungo Cert GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000010869</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Y060699</emdnCode>
    <emdnDescription>ORTHOSES, UPPER EXTREMITY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>type 3</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-02T15:53:18.165Z</lastUpdated>
  </row>
</eudamedExport>