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    <deviceName></deviceName>
    <manufacturerName>Leica Biosystems Nussloch GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000021943</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <legislation>IVDR 2017/746</legislation>
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    <reference>14035838925</reference>
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    <lastUpdated>2026-06-29T05:00:03.880Z</lastUpdated>
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    <tradeName>Leica DB80 LS</tradeName>
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    <manufacturerName>Leica Biosystems Nussloch GmbH</manufacturerName>
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    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <udiDi>04049188159496</udiDi>
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    <tradeName>Leica DB80 HS</tradeName>
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    <manufacturerName>Leica Biosystems Nussloch GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000021943</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <deviceStatus>Piyasada</deviceStatus>
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    <lastUpdated>2026-06-29T05:00:03.769Z</lastUpdated>
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    <udiDi>04049188159526</udiDi>
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    <tradeName>Leica DB80 LX</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Leica Biosystems Nussloch GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000021943</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
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    <emdnCode>V010302</emdnCode>
    <emdnDescription>BLADES WITHOUT SAFETY SYSTEMS, SINGLE-USE - NOT INCLUDED IN OTHER CLASSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>14035843496</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-29T05:00:03.744Z</lastUpdated>
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  <row>
    <udiDi>06951933811222</udiDi>
    <basicUdiDi>69519338SBGV</basicUdiDi>
    <tradeName>PRIMEDGE</tradeName>
    <deviceName>Surgical Blades</deviceName>
    <manufacturerName>Huaian Tianda Medical Instruments Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000031504</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>V010302</emdnCode>
    <emdnDescription>BLADES WITHOUT SAFETY SYSTEMS, SINGLE-USE - NOT INCLUDED IN OTHER CLASSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0722</reference>
    <placedOnMarketCountry>Latvia</placedOnMarketCountry>
    <lastUpdated>2026-06-28T08:21:21.191Z</lastUpdated>
  </row>
  <row>
    <udiDi>06951933811208</udiDi>
    <basicUdiDi>69519338SBGV</basicUdiDi>
    <tradeName>PRIMEDGE</tradeName>
    <deviceName>Surgical Blades</deviceName>
    <manufacturerName>Huaian Tianda Medical Instruments Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000031504</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>V010302</emdnCode>
    <emdnDescription>BLADES WITHOUT SAFETY SYSTEMS, SINGLE-USE - NOT INCLUDED IN OTHER CLASSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0720</reference>
    <placedOnMarketCountry>Latvia</placedOnMarketCountry>
    <lastUpdated>2026-06-28T08:21:19.997Z</lastUpdated>
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    <udiDi>06951933811154</udiDi>
    <basicUdiDi>69519338SBGV</basicUdiDi>
    <tradeName>PRIMEDGE</tradeName>
    <deviceName>Surgical Blades</deviceName>
    <manufacturerName>Huaian Tianda Medical Instruments Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000031504</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
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    <emdnCode>V010302</emdnCode>
    <emdnDescription>BLADES WITHOUT SAFETY SYSTEMS, SINGLE-USE - NOT INCLUDED IN OTHER CLASSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0715</reference>
    <placedOnMarketCountry>Latvia</placedOnMarketCountry>
    <lastUpdated>2026-06-28T08:21:18.898Z</lastUpdated>
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    <udiDi>06951933811123</udiDi>
    <basicUdiDi>69519338SBGV</basicUdiDi>
    <tradeName>PRIMEDGE</tradeName>
    <deviceName>Surgical Blades</deviceName>
    <manufacturerName>Huaian Tianda Medical Instruments Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000031504</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>V010302</emdnCode>
    <emdnDescription>BLADES WITHOUT SAFETY SYSTEMS, SINGLE-USE - NOT INCLUDED IN OTHER CLASSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0712</reference>
    <placedOnMarketCountry>Latvia</placedOnMarketCountry>
    <lastUpdated>2026-06-28T08:21:16.414Z</lastUpdated>
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    <udiDi>06951933811116</udiDi>
    <basicUdiDi>69519338SBGV</basicUdiDi>
    <tradeName>PRIMEDGE</tradeName>
    <deviceName>Surgical Blades</deviceName>
    <manufacturerName>Huaian Tianda Medical Instruments Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000031504</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>V010302</emdnCode>
    <emdnDescription>BLADES WITHOUT SAFETY SYSTEMS, SINGLE-USE - NOT INCLUDED IN OTHER CLASSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0711</reference>
    <placedOnMarketCountry>Latvia</placedOnMarketCountry>
    <lastUpdated>2026-06-28T08:21:10.390Z</lastUpdated>
  </row>
  <row>
    <udiDi>06951933811109</udiDi>
    <basicUdiDi>69519338SBGV</basicUdiDi>
    <tradeName>PRIMEDGE</tradeName>
    <deviceName>Surgical Blades</deviceName>
    <manufacturerName>Huaian Tianda Medical Instruments Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000031504</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>V010302</emdnCode>
    <emdnDescription>BLADES WITHOUT SAFETY SYSTEMS, SINGLE-USE - NOT INCLUDED IN OTHER CLASSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0710</reference>
    <placedOnMarketCountry>Latvia</placedOnMarketCountry>
    <lastUpdated>2026-06-28T08:21:09.476Z</lastUpdated>
  </row>
  <row>
    <udiDi>16945630144292</udiDi>
    <basicUdiDi>6945630110BA</basicUdiDi>
    <tradeName>SIMPLEE</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Sterilance Medical (Suzhou) Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000002860</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>V010302</emdnCode>
    <emdnDescription>BLADES WITHOUT SAFETY SYSTEMS, SINGLE-USE - NOT INCLUDED IN OTHER CLASSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>156 624</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-26T19:55:39.601Z</lastUpdated>
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  <row>
    <udiDi>06938535543430</udiDi>
    <basicUdiDi>69385355SurgicalbladeCRWE</basicUdiDi>
    <tradeName>06938535543430</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Huaiyin Medical Instruments Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000003351</manufacturerSrn>
    <authorisedRepresentativeName>Wellkang Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>XI-AR-000001836</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>V010302</emdnCode>
    <emdnDescription>BLADES WITHOUT SAFETY SYSTEMS, SINGLE-USE - NOT INCLUDED IN OTHER CLASSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>24</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-06-24T21:52:54.409Z</lastUpdated>
  </row>
  <row>
    <udiDi>06938535543423</udiDi>
    <basicUdiDi>69385355SurgicalbladeCRWE</basicUdiDi>
    <tradeName>06938535543423</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Huaiyin Medical Instruments Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000003351</manufacturerSrn>
    <authorisedRepresentativeName>Wellkang Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>XI-AR-000001836</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>V010302</emdnCode>
    <emdnDescription>BLADES WITHOUT SAFETY SYSTEMS, SINGLE-USE - NOT INCLUDED IN OTHER CLASSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>23</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-06-24T21:52:53.223Z</lastUpdated>
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  <row>
    <udiDi>06938535543416</udiDi>
    <basicUdiDi>69385355SurgicalbladeCRWE</basicUdiDi>
    <tradeName>06938535543416</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Huaiyin Medical Instruments Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000003351</manufacturerSrn>
    <authorisedRepresentativeName>Wellkang Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>XI-AR-000001836</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>V010302</emdnCode>
    <emdnDescription>BLADES WITHOUT SAFETY SYSTEMS, SINGLE-USE - NOT INCLUDED IN OTHER CLASSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>22</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-06-24T21:52:52.054Z</lastUpdated>
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    <udiDi>06938535543409</udiDi>
    <basicUdiDi>69385355SurgicalbladeCRWE</basicUdiDi>
    <tradeName>06938535543409</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Huaiyin Medical Instruments Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000003351</manufacturerSrn>
    <authorisedRepresentativeName>Wellkang Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>XI-AR-000001836</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>V010302</emdnCode>
    <emdnDescription>BLADES WITHOUT SAFETY SYSTEMS, SINGLE-USE - NOT INCLUDED IN OTHER CLASSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>21</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-06-24T21:52:50.818Z</lastUpdated>
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    <udiDi>06938535543393</udiDi>
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    <tradeName>06938535543393</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Huaiyin Medical Instruments Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000003351</manufacturerSrn>
    <authorisedRepresentativeName>Wellkang Ltd</authorisedRepresentativeName>
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    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>V010302</emdnCode>
    <emdnDescription>BLADES WITHOUT SAFETY SYSTEMS, SINGLE-USE - NOT INCLUDED IN OTHER CLASSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>20</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-06-24T21:52:49.626Z</lastUpdated>
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    <udiDi>06938535543379</udiDi>
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    <deviceName></deviceName>
    <manufacturerName>Huaiyin Medical Instruments Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000003351</manufacturerSrn>
    <authorisedRepresentativeName>Wellkang Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>XI-AR-000001836</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>V010302</emdnCode>
    <emdnDescription>BLADES WITHOUT SAFETY SYSTEMS, SINGLE-USE - NOT INCLUDED IN OTHER CLASSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>18</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-06-24T21:52:48.410Z</lastUpdated>
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    <udiDi>06938535543348</udiDi>
    <basicUdiDi>69385355SurgicalbladeCRWE</basicUdiDi>
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    <deviceName></deviceName>
    <manufacturerName>Huaiyin Medical Instruments Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000003351</manufacturerSrn>
    <authorisedRepresentativeName>Wellkang Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>XI-AR-000001836</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>V010302</emdnCode>
    <emdnDescription>BLADES WITHOUT SAFETY SYSTEMS, SINGLE-USE - NOT INCLUDED IN OTHER CLASSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>15C</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-06-24T21:52:47.208Z</lastUpdated>
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    <basicUdiDi>69385355SurgicalbladeCRWE</basicUdiDi>
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    <deviceName></deviceName>
    <manufacturerName>Huaiyin Medical Instruments Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000003351</manufacturerSrn>
    <authorisedRepresentativeName>Wellkang Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>XI-AR-000001836</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>V010302</emdnCode>
    <emdnDescription>BLADES WITHOUT SAFETY SYSTEMS, SINGLE-USE - NOT INCLUDED IN OTHER CLASSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>15</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-06-24T21:52:46.003Z</lastUpdated>
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    <basicUdiDi>69385355SurgicalbladeCRWE</basicUdiDi>
    <tradeName>06938535543294</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Huaiyin Medical Instruments Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000003351</manufacturerSrn>
    <authorisedRepresentativeName>Wellkang Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>XI-AR-000001836</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>V010302</emdnCode>
    <emdnDescription>BLADES WITHOUT SAFETY SYSTEMS, SINGLE-USE - NOT INCLUDED IN OTHER CLASSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>12</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-06-24T21:52:44.824Z</lastUpdated>
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