<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>06974712704508</udiDi>
    <basicUdiDi>697471270TBKZ01PU</basicUdiDi>
    <tradeName>06974712704508</tradeName>
    <deviceName>Disposable Face Mask</deviceName>
    <manufacturerName>Ningbo Tianbo First Aid Product Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000016721</manufacturerSrn>
    <authorisedRepresentativeName>Prolinx GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005129</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>T020604</emdnCode>
    <emdnDescription>MEDICAL USE FACE MASKS, TYPE II AND IIR</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Rule 1</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-02T14:18:13.781Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974712704201</udiDi>
    <basicUdiDi>697471270TBSJP1RZ</basicUdiDi>
    <tradeName>06974712704201</tradeName>
    <deviceName>wipe</deviceName>
    <manufacturerName>Ningbo Tianbo First Aid Product Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000016721</manufacturerSrn>
    <authorisedRepresentativeName>Prolinx GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005129</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>M04040101</emdnCode>
    <emdnDescription>SALINE DRESSINGS, NON-COMBINED</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Rule 4</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-02T14:18:13.007Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974712704102</udiDi>
    <basicUdiDi>697471270TBXDSJTX</basicUdiDi>
    <tradeName>06974712704102</tradeName>
    <deviceName>Wipe、Alcohol pad、BZK</deviceName>
    <manufacturerName>Ningbo Tianbo First Aid Product Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000016721</manufacturerSrn>
    <authorisedRepresentativeName>Prolinx GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005129</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>V0799</emdnCode>
    <emdnDescription>PRODUCTS FOR CLEANING MEDICAL DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Rule 41</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-02T14:18:12.204Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974712703907</udiDi>
    <basicUdiDi>697471270TBBD02JH</basicUdiDi>
    <tradeName>06974712703907</tradeName>
    <deviceName>Medical Bandage、Triangular bandage</deviceName>
    <manufacturerName>Ningbo Tianbo First Aid Product Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000016721</manufacturerSrn>
    <authorisedRepresentativeName>Prolinx GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005129</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>M030299</emdnCode>
    <emdnDescription>MEDICATED BANDAGES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Rule 1</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-02T14:18:11.384Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974712703709</udiDi>
    <basicUdiDi>697471270TBJD01L7</basicUdiDi>
    <tradeName>06974712703709</tradeName>
    <deviceName>Medical Tape</deviceName>
    <manufacturerName>Ningbo Tianbo First Aid Product Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000016721</manufacturerSrn>
    <authorisedRepresentativeName>Prolinx GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005129</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>H900299</emdnCode>
    <emdnDescription>TAPES, MEDICAL/SURGICAL - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Rule 1</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-02T14:18:07.391Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974712703303</udiDi>
    <basicUdiDi>697471270TBJJT1QE</basicUdiDi>
    <tradeName>06974712703303</tradeName>
    <deviceName>EMERGENCY BLANKET</deviceName>
    <manufacturerName>Ningbo Tianbo First Aid Product Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000016721</manufacturerSrn>
    <authorisedRepresentativeName>Prolinx GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005129</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>T030301</emdnCode>
    <emdnDescription>AIR FLOW BLANKETS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Rule 1</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-02T14:18:06.575Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974712703006</udiDi>
    <basicUdiDi>697471270TBSBJ1Q7</basicUdiDi>
    <tradeName>06974712703006</tradeName>
    <deviceName>Gauze Roll</deviceName>
    <manufacturerName>Ningbo Tianbo First Aid Product Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000016721</manufacturerSrn>
    <authorisedRepresentativeName>Prolinx GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005129</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>M020107</emdnCode>
    <emdnDescription>COTTON GAUZES IN ROLLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Rule 4</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-02T14:18:05.789Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974712703501</udiDi>
    <basicUdiDi>697471270TBJD02L9</basicUdiDi>
    <tradeName>06974712703501</tradeName>
    <deviceName>Scissors</deviceName>
    <manufacturerName>Ningbo Tianbo First Aid Product Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000016721</manufacturerSrn>
    <authorisedRepresentativeName>Prolinx GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005129</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>L01040102</emdnCode>
    <emdnDescription>SCISSORS FOR BANDAGES, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Rule 1</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-02T14:18:05.003Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974712702504</udiDi>
    <basicUdiDi>697471270TBSBP1QR</basicUdiDi>
    <tradeName>06974712702504</tradeName>
    <deviceName>Gauze Sponges</deviceName>
    <manufacturerName>Ningbo Tianbo First Aid Product Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000016721</manufacturerSrn>
    <authorisedRepresentativeName>Prolinx GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005129</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>M0202030101</emdnCode>
    <emdnDescription>NON-WOVEN GAUZE PADS, WITHOUT X-RAY DETECTABLE THREAD, STERILE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>rule 4</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-02T14:18:01.103Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974712702108</udiDi>
    <basicUdiDi>697471270TBCKT1P2</basicUdiDi>
    <tradeName>06974712702108</tradeName>
    <deviceName>Wound Plaster</deviceName>
    <manufacturerName>Ningbo Tianbo First Aid Product Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000016721</manufacturerSrn>
    <authorisedRepresentativeName>Prolinx GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005129</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>M0599</emdnCode>
    <emdnDescription>MEDICAL PLASTERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Rule 4</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T14:17:47.309Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974712702009</udiDi>
    <basicUdiDi>697471270TBST01QN</basicUdiDi>
    <tradeName>06974712702009</tradeName>
    <deviceName>Disposable Gloves</deviceName>
    <manufacturerName>Ningbo Tianbo First Aid Product Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000016721</manufacturerSrn>
    <authorisedRepresentativeName>Prolinx GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005129</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>T0199</emdnCode>
    <emdnDescription>GLOVES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Rule 1</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-02T14:17:45.753Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974712700012</udiDi>
    <basicUdiDi>697471270TBJJB1NQ</basicUdiDi>
    <tradeName>06974712700012</tradeName>
    <deviceName>First aid kit</deviceName>
    <manufacturerName>Ningbo Tianbo First Aid Product Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000016721</manufacturerSrn>
    <authorisedRepresentativeName>Prolinx GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005129</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>T0203</emdnCode>
    <emdnDescription>DRESSING AND ASSISTANCE KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Rule 4</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T14:17:44.902Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974600433008</udiDi>
    <basicUdiDi>697460043FFUQB</basicUdiDi>
    <tradeName>06974600433008</tradeName>
    <deviceName>FULL RIM ULTEM OPTICAL FRAMES</deviceName>
    <manufacturerName>WENZHOU SENSE OPTICAL CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000009540</manufacturerSrn>
    <authorisedRepresentativeName>Prolinx GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005129</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q02100202</emdnCode>
    <emdnDescription>PLASTIC SPECTACLE FRAMES WITHOUT LENSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AE8097-4</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-02T13:41:13.822Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974600432094</udiDi>
    <basicUdiDi>697460043FFTQ9</basicUdiDi>
    <tradeName>06974600432094</tradeName>
    <deviceName>FULL RIM TITANIUM OPTICAL FRAMES</deviceName>
    <manufacturerName>WENZHOU SENSE OPTICAL CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000009540</manufacturerSrn>
    <authorisedRepresentativeName>Prolinx GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005129</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q02100201</emdnCode>
    <emdnDescription>METAL SPECTACLE FRAMES WITHOUT LENSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SOEC103</reference>
    <placedOnMarketCountry>Latvia</placedOnMarketCountry>
    <lastUpdated>2026-07-02T13:41:13.013Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974600430465</udiDi>
    <basicUdiDi>697460043FFRQ5</basicUdiDi>
    <tradeName>06974600430465</tradeName>
    <deviceName>FULL RIM TR90 OPTICAL FRAMES</deviceName>
    <manufacturerName>WENZHOU SENSE OPTICAL CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000009540</manufacturerSrn>
    <authorisedRepresentativeName>Prolinx GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005129</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q02100202</emdnCode>
    <emdnDescription>PLASTIC SPECTACLE FRAMES WITHOUT LENSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>JA15858-4</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-02T13:41:11.413Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974600430212</udiDi>
    <basicUdiDi>697460043SFMRU</basicUdiDi>
    <tradeName>06974600430212</tradeName>
    <deviceName>FULL RIM STAINLESS STEEL SUNGLASSES</deviceName>
    <manufacturerName>WENZHOU SENSE OPTICAL CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000009540</manufacturerSrn>
    <authorisedRepresentativeName>Prolinx GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005129</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q0210030101</emdnCode>
    <emdnDescription>READY TO WEAR METAL SPECTACLES WITH ORGANIC LENSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R21552-1</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-02T13:41:09.013Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974600430403</udiDi>
    <basicUdiDi>697460043SFPS2</basicUdiDi>
    <tradeName>06974600430403</tradeName>
    <deviceName>FULL RIM PLASTIC SUNGLASSES</deviceName>
    <manufacturerName>WENZHOU SENSE OPTICAL CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000009540</manufacturerSrn>
    <authorisedRepresentativeName>Prolinx GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005129</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q0210030102</emdnCode>
    <emdnDescription>READY TO WEAR PLASTIC SPECTACLES WITH ORGANIC LENSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DP3055-0 LIVIA</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-02T13:41:07.444Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974600430014</udiDi>
    <basicUdiDi>697460043FFPPZ</basicUdiDi>
    <tradeName>06974600430014</tradeName>
    <deviceName>Plastic Full Rim</deviceName>
    <manufacturerName>WENZHOU SENSE OPTICAL CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000009540</manufacturerSrn>
    <authorisedRepresentativeName>Prolinx GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005129</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q02100202</emdnCode>
    <emdnDescription>PLASTIC SPECTACLE FRAMES WITHOUT LENSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Plastic Optical Frame</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-02T13:41:06.618Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974600430021</udiDi>
    <basicUdiDi>697460043FHMPZ</basicUdiDi>
    <tradeName>Optical Frame</tradeName>
    <deviceName>Metal Half Rim</deviceName>
    <manufacturerName>WENZHOU SENSE OPTICAL CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000009540</manufacturerSrn>
    <authorisedRepresentativeName>Prolinx GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005129</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q02100201</emdnCode>
    <emdnDescription>METAL SPECTACLE FRAMES WITHOUT LENSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Metal Optical Frame</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-02T13:41:05.045Z</lastUpdated>
  </row>
  <row>
    <udiDi>06974600430007</udiDi>
    <basicUdiDi>697460043FFMPT</basicUdiDi>
    <tradeName>Optical Frame</tradeName>
    <deviceName>Metal Full Rim</deviceName>
    <manufacturerName>WENZHOU SENSE OPTICAL CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000009540</manufacturerSrn>
    <authorisedRepresentativeName>Prolinx GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005129</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q02100201</emdnCode>
    <emdnDescription>METAL SPECTACLE FRAMES WITHOUT LENSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Metal Optical Frame</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-02T13:40:49.749Z</lastUpdated>
  </row>
</eudamedExport>