<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>06931747852451</udiDi>
    <basicUdiDi>69317478SSG0000019C</basicUdiDi>
    <tradeName>SMS standard surgical gown M</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Xuchang Zhengde Environstar Medical Products Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000009427</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>T020401</emdnCode>
    <emdnDescription>STANDARD SURGICAL GOWNS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Z564B124004S</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-09T18:30:29.787Z</lastUpdated>
  </row>
  <row>
    <udiDi>06931747852475</udiDi>
    <basicUdiDi>69317478SSG0000029E</basicUdiDi>
    <tradeName>SMS reinforced surgical gown M</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Xuchang Zhengde Environstar Medical Products Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000009427</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>T020402</emdnCode>
    <emdnDescription>REINFORCED SURGICAL GOWNS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Z564B124004R</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-09T18:30:29.755Z</lastUpdated>
  </row>
  <row>
    <udiDi>06931747852499</udiDi>
    <basicUdiDi>69317478SSG0000019C</basicUdiDi>
    <tradeName>SMS standard surgical gown XL-S</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Xuchang Zhengde Environstar Medical Products Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000009427</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>T020401</emdnCode>
    <emdnDescription>STANDARD SURGICAL GOWNS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Z564B124005S</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-09T18:30:29.733Z</lastUpdated>
  </row>
  <row>
    <udiDi>06931747852512</udiDi>
    <basicUdiDi>69317478SSG0000029E</basicUdiDi>
    <tradeName>SMS reinforced surgical gown XL-S</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Xuchang Zhengde Environstar Medical Products Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000009427</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>T020402</emdnCode>
    <emdnDescription>REINFORCED SURGICAL GOWNS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Z564B124005R</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-09T18:30:29.708Z</lastUpdated>
  </row>
  <row>
    <udiDi>06931747852536</udiDi>
    <basicUdiDi>69317478SSG0000019C</basicUdiDi>
    <tradeName>SMS standard surgical gown XL-L</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Xuchang Zhengde Environstar Medical Products Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000009427</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>T020401</emdnCode>
    <emdnDescription>STANDARD SURGICAL GOWNS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Z564B124006S</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-09T18:30:29.694Z</lastUpdated>
  </row>
  <row>
    <udiDi>06931747852550</udiDi>
    <basicUdiDi>69317478SSG0000029E</basicUdiDi>
    <tradeName>SMS reinforced surgical gown XL-L</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Xuchang Zhengde Environstar Medical Products Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000009427</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>T020402</emdnCode>
    <emdnDescription>REINFORCED SURGICAL GOWNS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Z564B124006R</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-09T18:30:29.675Z</lastUpdated>
  </row>
  <row>
    <udiDi>06931747855919</udiDi>
    <basicUdiDi>69317478NSSG00000124</basicUdiDi>
    <tradeName>Reinforced surgical gown</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Xuchang Zhengde Environstar Medical Products Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000009427</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>T020401</emdnCode>
    <emdnDescription>REINFORCED SURGICAL GOWNS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>17523-2</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-09T18:30:29.399Z</lastUpdated>
  </row>
  <row>
    <udiDi>06931747855926</udiDi>
    <basicUdiDi>69317478NSSG00000124</basicUdiDi>
    <tradeName>Reinforced surgical gown</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Xuchang Zhengde Environstar Medical Products Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000009427</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>T020401</emdnCode>
    <emdnDescription>REINFORCED SURGICAL GOWNS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>18341-2</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-09T18:30:29.374Z</lastUpdated>
  </row>
  <row>
    <udiDi>08698918078345</udiDi>
    <basicUdiDi>B-08698918078345</basicUdiDi>
    <tradeName>08698918078345</tradeName>
    <deviceName>DISPOSABLE NON-STERILE CHEMOTHERAPY GOWN L</deviceName>
    <manufacturerName>3 TEKS TEKSTİL GIDA İTH.İHR.SAN. VE TİC.LTD.ŞTİ.</manufacturerName>
    <manufacturerSrn>TR-MF-000032256</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>T020401</emdnCode>
    <emdnDescription>STANDARD SURGICAL GOWNS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>235-00-05</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-09T12:13:39.498Z</lastUpdated>
  </row>
  <row>
    <udiDi>08698918076471</udiDi>
    <basicUdiDi>B-08698918076471</basicUdiDi>
    <tradeName>08698918076471</tradeName>
    <deviceName>DISPOSABLE NON-STERILE EXAM COVER</deviceName>
    <manufacturerName>3 TEKS TEKSTİL GIDA İTH.İHR.SAN. VE TİC.LTD.ŞTİ.</manufacturerName>
    <manufacturerSrn>TR-MF-000032256</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>T020401</emdnCode>
    <emdnDescription>STANDARD SURGICAL GOWNS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>235-00-38</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-09T12:12:17.280Z</lastUpdated>
  </row>
  <row>
    <udiDi>08698918076105</udiDi>
    <basicUdiDi>B-08698918076105</basicUdiDi>
    <tradeName>08698918076105</tradeName>
    <deviceName>DISPOSABLE NON-STERILE CHEMOTHERAPY GOWN XL</deviceName>
    <manufacturerName>3 TEKS TEKSTİL GIDA İTH.İHR.SAN. VE TİC.LTD.ŞTİ.</manufacturerName>
    <manufacturerSrn>TR-MF-000032256</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>T020401</emdnCode>
    <emdnDescription>STANDARD SURGICAL GOWNS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>235-00-05</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-09T12:12:11.671Z</lastUpdated>
  </row>
  <row>
    <udiDi>08698918075580</udiDi>
    <basicUdiDi>B-08698918075580</basicUdiDi>
    <tradeName>08698918075580</tradeName>
    <deviceName>DISPOSABLE NON-STERILE GASTROSCOPY GOWN, WITH POCKET</deviceName>
    <manufacturerName>3 TEKS TEKSTİL GIDA İTH.İHR.SAN. VE TİC.LTD.ŞTİ.</manufacturerName>
    <manufacturerSrn>TR-MF-000032256</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>T020401</emdnCode>
    <emdnDescription>STANDARD SURGICAL GOWNS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>235-00-10</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-09T12:12:04.900Z</lastUpdated>
  </row>
  <row>
    <udiDi>08698918075573</udiDi>
    <basicUdiDi>B-08698918075573</basicUdiDi>
    <tradeName>08698918075573</tradeName>
    <deviceName>DISPOSABLE NON-STERILE GASTROSCOPY GOWN</deviceName>
    <manufacturerName>3 TEKS TEKSTİL GIDA İTH.İHR.SAN. VE TİC.LTD.ŞTİ.</manufacturerName>
    <manufacturerSrn>TR-MF-000032256</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>T020401</emdnCode>
    <emdnDescription>STANDARD SURGICAL GOWNS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>235-00-09</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-09T12:12:03.864Z</lastUpdated>
  </row>
  <row>
    <udiDi>08698918075221</udiDi>
    <basicUdiDi>B-08698918075221</basicUdiDi>
    <tradeName>08698918075221</tradeName>
    <deviceName>DISPOSABLE NON-STERILE SCRUB SUIT (LONG SLEEVE) (S-M-L-XL-XXL)</deviceName>
    <manufacturerName>3 TEKS TEKSTİL GIDA İTH.İHR.SAN. VE TİC.LTD.ŞTİ.</manufacturerName>
    <manufacturerSrn>TR-MF-000032256</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>T020401</emdnCode>
    <emdnDescription>STANDARD SURGICAL GOWNS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>235-00-32</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-09T12:11:26.793Z</lastUpdated>
  </row>
  <row>
    <udiDi>08698918074521</udiDi>
    <basicUdiDi>B-08698918074521</basicUdiDi>
    <tradeName>08698918074521</tradeName>
    <deviceName>DISPOSABLE STERILE REINFORCED SURGICAL GOWN 3XL</deviceName>
    <manufacturerName>3 TEKS TEKSTİL GIDA İTH.İHR.SAN. VE TİC.LTD.ŞTİ.</manufacturerName>
    <manufacturerSrn>TR-MF-000032256</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>T020402</emdnCode>
    <emdnDescription>REINFORCED SURGICAL GOWNS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>221-601</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-09T12:11:00.387Z</lastUpdated>
  </row>
  <row>
    <udiDi>08698918074477</udiDi>
    <basicUdiDi>B-08698918074477</basicUdiDi>
    <tradeName>08698918074477</tradeName>
    <deviceName>Disposable Non-Sterile Reinforced Surgical Gown (S-M-L-XL-XXL)</deviceName>
    <manufacturerName>3 TEKS TEKSTİL GIDA İTH.İHR.SAN. VE TİC.LTD.ŞTİ.</manufacturerName>
    <manufacturerSrn>TR-MF-000032256</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>T020402</emdnCode>
    <emdnDescription>REINFORCED SURGICAL GOWNS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>235-00-13</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-09T12:10:59.587Z</lastUpdated>
  </row>
  <row>
    <udiDi>08698918074460</udiDi>
    <basicUdiDi>B-08698918074460</basicUdiDi>
    <tradeName>08698918074460</tradeName>
    <deviceName>DISPOSABLE NON-STERILE SPUNLACE REINFORCED SURGICAL GOWN( S-M-L-XL-XXL )</deviceName>
    <manufacturerName>3 TEKS TEKSTİL GIDA İTH.İHR.SAN. VE TİC.LTD.ŞTİ.</manufacturerName>
    <manufacturerSrn>TR-MF-000032256</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>T020401</emdnCode>
    <emdnDescription>STANDARD SURGICAL GOWNS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>235-00-17</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-09T12:10:58.795Z</lastUpdated>
  </row>
  <row>
    <udiDi>08698918074446</udiDi>
    <basicUdiDi>B-08698918074446</basicUdiDi>
    <tradeName>08698918074446</tradeName>
    <deviceName>DISPOSABLE NON-STERILE STANDARD SURGICAL GOWN ( S-M-L-XL-XXL )</deviceName>
    <manufacturerName>3 TEKS TEKSTİL GIDA İTH.İHR.SAN. VE TİC.LTD.ŞTİ.</manufacturerName>
    <manufacturerSrn>TR-MF-000032256</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>T020401</emdnCode>
    <emdnDescription>STANDARD SURGICAL GOWNS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>235-00-12</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-09T12:10:53.185Z</lastUpdated>
  </row>
  <row>
    <udiDi>08698918074439</udiDi>
    <basicUdiDi>B-08698918074439</basicUdiDi>
    <tradeName>08698918074439</tradeName>
    <deviceName>Disposable Non-Sterile Triplex Full Protection Surgical Gown (S-M-L-XL-XXL)</deviceName>
    <manufacturerName>3 TEKS TEKSTİL GIDA İTH.İHR.SAN. VE TİC.LTD.ŞTİ.</manufacturerName>
    <manufacturerSrn>TR-MF-000032256</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>T020402</emdnCode>
    <emdnDescription>REINFORCED SURGICAL GOWNS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>235-00-14</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-09T12:10:52.996Z</lastUpdated>
  </row>
  <row>
    <udiDi>08698918074248</udiDi>
    <basicUdiDi>B-08698918074248</basicUdiDi>
    <tradeName>08698918074248</tradeName>
    <deviceName>DISPOSABLE STERILE TRIPLEX FULL REINFORCED SURGICAL GOWN XXL</deviceName>
    <manufacturerName>3 TEKS TEKSTİL GIDA İTH.İHR.SAN. VE TİC.LTD.ŞTİ.</manufacturerName>
    <manufacturerSrn>TR-MF-000032256</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>T020402</emdnCode>
    <emdnDescription>REINFORCED SURGICAL GOWNS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>242-501</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-09T12:10:22.884Z</lastUpdated>
  </row>
</eudamedExport>