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<eudamedExport entity="devices">
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    <udiDi>06945632020405</udiDi>
    <basicUdiDi>69456320OS001NK</basicUdiDi>
    <tradeName>SOFTMED</tradeName>
    <deviceName>Oral syringes</deviceName>
    <manufacturerName>Changzhou Tongda Medical Appliance Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000027398</manufacturerSrn>
    <authorisedRepresentativeName>Caretechion GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005946</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A020108</emdnCode>
    <emdnDescription>ENTERAL FEEDING SYRINGES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TD-OS-1ml</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-06-27T18:43:38.318Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945632020276</udiDi>
    <basicUdiDi>69456320SVN002TH</basicUdiDi>
    <tradeName>BIOSAFE</tradeName>
    <deviceName>Disposable Scalp Vein Needles</deviceName>
    <manufacturerName>Changzhou Tongda Medical Appliance Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000027398</manufacturerSrn>
    <authorisedRepresentativeName>Caretechion GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005946</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A01010202</emdnCode>
    <emdnDescription>BUTTERFLY NEEDLES, W/O SAFETY SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TD-SV-B-0.5mm</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-06-27T18:43:32.307Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945632020269</udiDi>
    <basicUdiDi>69456320SVN002TH</basicUdiDi>
    <tradeName>BIOSAFE</tradeName>
    <deviceName>Disposable Scalp Vein Needles</deviceName>
    <manufacturerName>Changzhou Tongda Medical Appliance Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000027398</manufacturerSrn>
    <authorisedRepresentativeName>Caretechion GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005946</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A01010202</emdnCode>
    <emdnDescription>BUTTERFLY NEEDLES, W/O SAFETY SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TD-SV-B-0.6mm</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-06-27T18:43:31.103Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945632020252</udiDi>
    <basicUdiDi>69456320SVN002TH</basicUdiDi>
    <tradeName>BIOSAFE</tradeName>
    <deviceName>Disposable Scalp Vein Needles</deviceName>
    <manufacturerName>Changzhou Tongda Medical Appliance Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000027398</manufacturerSrn>
    <authorisedRepresentativeName>Caretechion GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005946</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A01010202</emdnCode>
    <emdnDescription>BUTTERFLY NEEDLES, W/O SAFETY SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TD-SV-B-0.8mm</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-06-27T18:43:29.902Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945632020245</udiDi>
    <basicUdiDi>69456320SVN002TH</basicUdiDi>
    <tradeName>BIOSAFE</tradeName>
    <deviceName>Disposable Scalp Vein Needles</deviceName>
    <manufacturerName>Changzhou Tongda Medical Appliance Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000027398</manufacturerSrn>
    <authorisedRepresentativeName>Caretechion GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005946</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A01010202</emdnCode>
    <emdnDescription>BUTTERFLY NEEDLES, W/O SAFETY SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TD-SV-B-0.9mm</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-06-27T18:43:28.712Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945632020238</udiDi>
    <basicUdiDi>69456320AD002EJ</basicUdiDi>
    <tradeName>SOFTMED</tradeName>
    <deviceName>Disposable Auto-destroy Syringes with Needle</deviceName>
    <manufacturerName>Changzhou Tongda Medical Appliance Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000027398</manufacturerSrn>
    <authorisedRepresentativeName>Caretechion GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005946</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A020102010201</emdnCode>
    <emdnDescription>INFUSION AND IRRIGATION SYRINGES, LUER CONE, 3-PIECE WITH NEEDLE, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TD-AD-B-10ml-0.7mm</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-06-27T18:43:22.839Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945632020221</udiDi>
    <basicUdiDi>69456320AD001EG</basicUdiDi>
    <tradeName>SOFTMED</tradeName>
    <deviceName>Disposable Auto-destroy Syringes with Needle</deviceName>
    <manufacturerName>Changzhou Tongda Medical Appliance Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000027398</manufacturerSrn>
    <authorisedRepresentativeName>Caretechion GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005946</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A020102010201</emdnCode>
    <emdnDescription>INFUSION AND IRRIGATION SYRINGES, LUER CONE, 3-PIECE WITH NEEDLE, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TD-AD-A-5ml-0.6mm</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-06-27T18:43:21.501Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945632020207</udiDi>
    <basicUdiDi>69456320INS004MW</basicUdiDi>
    <tradeName>BOISAFE</tradeName>
    <deviceName>Disposable Insulin Syringes</deviceName>
    <manufacturerName>Changzhou Tongda Medical Appliance Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000027398</manufacturerSrn>
    <authorisedRepresentativeName>Caretechion GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005946</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A02010601</emdnCode>
    <emdnDescription>INSULIN SYRINGES WITH FIXED NEEDLE, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TD-INS-D-1ml-U100-0.33mm</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-06-27T18:43:20.308Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945632020191</udiDi>
    <basicUdiDi>69456320INS002MS</basicUdiDi>
    <tradeName>SOFTMED</tradeName>
    <deviceName>Disposable Insulin Syringes</deviceName>
    <manufacturerName>Changzhou Tongda Medical Appliance Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000027398</manufacturerSrn>
    <authorisedRepresentativeName>Caretechion GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005946</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A02010601</emdnCode>
    <emdnDescription>INSULIN SYRINGES WITH FIXED NEEDLE, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TD-INS-B-1ml-U100-0.3mm</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-06-27T18:43:19.292Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945632020184</udiDi>
    <basicUdiDi>69456320INS001MQ</basicUdiDi>
    <tradeName>SOFTMED</tradeName>
    <deviceName>Disposable Insulin Syringes</deviceName>
    <manufacturerName>Changzhou Tongda Medical Appliance Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000027398</manufacturerSrn>
    <authorisedRepresentativeName>Caretechion GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005946</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A02010601</emdnCode>
    <emdnDescription>INSULIN SYRINGES WITH FIXED NEEDLE, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TD-INS-A-1ml-U100-0.3mm</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-06-27T18:43:13.093Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945632020160</udiDi>
    <basicUdiDi>69456320SYN002UJ</basicUdiDi>
    <tradeName>XINLI</tradeName>
    <deviceName>Disposable Sterile Syringes with Needle</deviceName>
    <manufacturerName>Changzhou Tongda Medical Appliance Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000027398</manufacturerSrn>
    <authorisedRepresentativeName>Caretechion GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005946</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A020102010201</emdnCode>
    <emdnDescription>INFUSION AND IRRIGATION SYRINGES, LUER CONE, 3-PIECE WITH NEEDLE, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TD-SN-B-10ml-0.8mm</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-06-27T18:43:12.230Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945632020153</udiDi>
    <basicUdiDi>69456320SYN006US</basicUdiDi>
    <tradeName>BIOSAFE</tradeName>
    <deviceName>Disposable Sterile Syringes with Needle</deviceName>
    <manufacturerName>Changzhou Tongda Medical Appliance Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000027398</manufacturerSrn>
    <authorisedRepresentativeName>Caretechion GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005946</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A020102010201</emdnCode>
    <emdnDescription>INFUSION AND IRRIGATION SYRINGES, LUER CONE, 3-PIECE WITH NEEDLE, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TD-SN-F-50ml-1.2mm</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-06-27T18:43:10.693Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945632020146</udiDi>
    <basicUdiDi>69456320SYN005UQ</basicUdiDi>
    <tradeName>BIOSAFE</tradeName>
    <deviceName>Disposable Sterile Syringes with Needle</deviceName>
    <manufacturerName>Changzhou Tongda Medical Appliance Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000027398</manufacturerSrn>
    <authorisedRepresentativeName>Caretechion GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005946</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A020102010201</emdnCode>
    <emdnDescription>INFUSION AND IRRIGATION SYRINGES, LUER CONE, 3-PIECE WITH NEEDLE, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TD-SN-E-2.5ml-0.6mm</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-06-27T18:43:09.847Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945632020085</udiDi>
    <basicUdiDi>69456320SVN001TF</basicUdiDi>
    <tradeName>XINLI</tradeName>
    <deviceName>Disposable Scalp Vein Needles</deviceName>
    <manufacturerName>Changzhou Tongda Medical Appliance Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000027398</manufacturerSrn>
    <authorisedRepresentativeName>Caretechion GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005946</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A01010202</emdnCode>
    <emdnDescription>BUTTERFLY NEEDLES, W/O SAFETY SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TD-SV-A-0.6mm</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-06-27T18:43:03.485Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945632020139</udiDi>
    <basicUdiDi>69456320SY002RB</basicUdiDi>
    <tradeName>MEDIZON</tradeName>
    <deviceName>Disposable sterile syringes without needle</deviceName>
    <manufacturerName>Changzhou Tongda Medical Appliance Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000027398</manufacturerSrn>
    <authorisedRepresentativeName>Caretechion GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005946</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A020102010202</emdnCode>
    <emdnDescription>INFUSION AND IRRIGATION SYRINGES, LUER CONE, 3-PIECE WITHOUT NEEDLE, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TD-SS-B-60ml</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-06-27T18:43:02.296Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945632020054</udiDi>
    <basicUdiDi>69456320SYN001UG</basicUdiDi>
    <tradeName>XINLI</tradeName>
    <deviceName>Disposable sterile syringes (with needle)</deviceName>
    <manufacturerName>Changzhou Tongda Medical Appliance Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000027398</manufacturerSrn>
    <authorisedRepresentativeName>Caretechion GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005946</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A020102010201</emdnCode>
    <emdnDescription>INFUSION AND IRRIGATION SYRINGES, LUER CONE, 3-PIECE WITH NEEDLE, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TD-SN-A-2.5ml-0.6mm</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-06-27T18:43:01.085Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945632020122</udiDi>
    <basicUdiDi>69456320SYN004UN</basicUdiDi>
    <tradeName>MEDIZON</tradeName>
    <deviceName>Disposable Sterile Syringes (with Needle)</deviceName>
    <manufacturerName>Changzhou Tongda Medical Appliance Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000027398</manufacturerSrn>
    <authorisedRepresentativeName>Caretechion GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005946</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A020102010201</emdnCode>
    <emdnDescription>INFUSION AND IRRIGATION SYRINGES, LUER CONE, 3-PIECE WITH NEEDLE, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TD-SN-D-20ml-0.8mm</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-06-27T18:42:59.897Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945632020108</udiDi>
    <basicUdiDi>69456320SYN001UG</basicUdiDi>
    <tradeName>MEDIZON</tradeName>
    <deviceName>Disposable sterile syringes (with needle)</deviceName>
    <manufacturerName>Changzhou Tongda Medical Appliance Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000027398</manufacturerSrn>
    <authorisedRepresentativeName>Caretechion GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005946</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A020102010201</emdnCode>
    <emdnDescription>INFUSION AND IRRIGATION SYRINGES, LUER CONE, 3-PIECE WITH NEEDLE, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TD-SN-A-1ml-0.4mm</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-06-27T18:42:55.087Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945632020115</udiDi>
    <basicUdiDi>69456320SYN001UG</basicUdiDi>
    <tradeName>MEDIZON</tradeName>
    <deviceName>Disposable sterile syringes (with needle)</deviceName>
    <manufacturerName>Changzhou Tongda Medical Appliance Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000027398</manufacturerSrn>
    <authorisedRepresentativeName>Caretechion GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005946</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A020102010201</emdnCode>
    <emdnDescription>INFUSION AND IRRIGATION SYRINGES, LUER CONE, 3-PIECE WITH NEEDLE, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TD-SN-A-10ml-0.8mm</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-06-27T18:42:53.886Z</lastUpdated>
  </row>
  <row>
    <udiDi>06945632020092</udiDi>
    <basicUdiDi>69456320SVN001TF</basicUdiDi>
    <tradeName>XINLI</tradeName>
    <deviceName>Disposable Scalp Vein Needles</deviceName>
    <manufacturerName>Changzhou Tongda Medical Appliance Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000027398</manufacturerSrn>
    <authorisedRepresentativeName>Caretechion GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005946</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A01010202</emdnCode>
    <emdnDescription>BUTTERFLY NEEDLES, W/O SAFETY SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TD-SV-A-0.5mm</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-06-27T18:42:52.619Z</lastUpdated>
  </row>
</eudamedExport>