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    <tradeName>Blood collection tube</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Guangdong Kindly Medical Device Group Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000006505</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W050101010202</emdnCode>
    <emdnDescription>BLOOD COLLECTION, TUBES WITHOUT ADDITIVES OR SERUM SEPARATOR</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6656</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T17:32:45.252Z</lastUpdated>
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    <udiDi>06956299701378</udiDi>
    <basicUdiDi>695629970005P7</basicUdiDi>
    <tradeName>Saliva RNA Sample Collection Kit</tradeName>
    <deviceName>IVD Sample Collection Kit</deviceName>
    <manufacturerName>Xiamen Zeesan Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000013246</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W05019002</emdnCode>
    <emdnDescription>SALIVA COLLECTION DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>401115</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-31T17:31:24.321Z</lastUpdated>
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    <udiDi>06955931304847</udiDi>
    <basicUdiDi>695593130025070001LA</basicUdiDi>
    <tradeName>Newborn Blood Spot Collection Card</tradeName>
    <deviceName>Newborn Blood Spot Collection Card</deviceName>
    <manufacturerName>Yaneng BIOscience (Shenzhen) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000013666</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0501010299</emdnCode>
    <emdnDescription>CAPILLARY BLOOD COLLECTION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>250701</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-31T17:29:34.937Z</lastUpdated>
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    <udiDi>06955931304687</udiDi>
    <basicUdiDi>695593130025030001JW</basicUdiDi>
    <tradeName>Urine Collection Tube</tradeName>
    <deviceName>Urine Collection Tube</deviceName>
    <manufacturerName>Yaneng BIOscience (Shenzhen) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000013666</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W05010202</emdnCode>
    <emdnDescription>URINE COLLECTION, TUBES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>250301</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-31T17:29:28.510Z</lastUpdated>
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  <row>
    <udiDi>06955931304328</udiDi>
    <basicUdiDi>695593130025080004LT</basicUdiDi>
    <tradeName>Urine Collection Tube</tradeName>
    <deviceName>Urine Collection Tube</deviceName>
    <manufacturerName>Yaneng BIOscience (Shenzhen) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000013666</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W05010202</emdnCode>
    <emdnDescription>URINE COLLECTION, TUBES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>250804</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-31T17:29:18.044Z</lastUpdated>
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  <row>
    <udiDi>06955931304281</udiDi>
    <basicUdiDi>695593130022050005J9</basicUdiDi>
    <tradeName>Cell Preservation Solution</tradeName>
    <deviceName>Cell Preservation Solution</deviceName>
    <manufacturerName>Yaneng BIOscience (Shenzhen) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000013666</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W05020199</emdnCode>
    <emdnDescription>SAMPLES TRANSPORT, CONTAINERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>220505</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-31T17:29:09.885Z</lastUpdated>
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    <udiDi>06955931304274</udiDi>
    <basicUdiDi>695593130022061714KX</basicUdiDi>
    <tradeName>Cell Preservation Solution</tradeName>
    <deviceName>Cell Preservation Solution</deviceName>
    <manufacturerName>Yaneng BIOscience (Shenzhen) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000013666</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W05020199</emdnCode>
    <emdnDescription>SAMPLES TRANSPORT, CONTAINERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2206QN</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-31T17:29:09.090Z</lastUpdated>
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    <udiDi>06955931302454</udiDi>
    <basicUdiDi>695593130022010001GM</basicUdiDi>
    <tradeName>Cell Preservation Solution</tradeName>
    <deviceName>Cell Preservation Solution</deviceName>
    <manufacturerName>Yaneng BIOscience (Shenzhen) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000013666</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W05020199</emdnCode>
    <emdnDescription>SAMPLES TRANSPORT, CONTAINERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>220101</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-31T17:28:54.681Z</lastUpdated>
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    <udiDi>06955931302409</udiDi>
    <basicUdiDi>695593130022020001GY</basicUdiDi>
    <tradeName>Sample Preservation Solution</tradeName>
    <deviceName>Sample Preservation Solution</deviceName>
    <manufacturerName>Yaneng BIOscience (Shenzhen) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000013666</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W05020199</emdnCode>
    <emdnDescription>SAMPLES TRANSPORT, CONTAINERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>220201</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-31T17:28:37.580Z</lastUpdated>
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  <row>
    <udiDi>06955931302379</udiDi>
    <basicUdiDi>69559313002025010001Q2</basicUdiDi>
    <tradeName>Stool Collection Tube</tradeName>
    <deviceName>Stool Collection Tube</deviceName>
    <manufacturerName>Yaneng BIOscience (Shenzhen) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000013666</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W05019001</emdnCode>
    <emdnDescription>FAECES COLLECTION DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>250101</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-31T17:28:36.822Z</lastUpdated>
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  <row>
    <udiDi>06954376005692</udiDi>
    <basicUdiDi>69543760F0003164</basicUdiDi>
    <tradeName>Immunodiagnostic Products Signal Reagent</tradeName>
    <deviceName>Immunodiagnostic Products Signal Reagent</deviceName>
    <manufacturerName>Beijing Leadman Biochemistry Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000020150</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0599</emdnCode>
    <emdnDescription>IVD GENERAL USE CONSUMABLE DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>69543760F0003164</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T17:27:05.348Z</lastUpdated>
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    <udiDi>06954376005265</udiDi>
    <basicUdiDi>69543760F000386J</basicUdiDi>
    <tradeName>Sample Diluent 5</tradeName>
    <deviceName>Sample Diluent 5</deviceName>
    <manufacturerName>Beijing Leadman Biochemistry Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000020150</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0599</emdnCode>
    <emdnDescription>IVD GENERAL USE CONSUMABLE DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>69543760F000386J</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T17:27:04.799Z</lastUpdated>
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    <udiDi>06954376005258</udiDi>
    <basicUdiDi>69543760F000376G</basicUdiDi>
    <tradeName>Sample Diluent 4</tradeName>
    <deviceName>Sample Diluent 4</deviceName>
    <manufacturerName>Beijing Leadman Biochemistry Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000020150</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0599</emdnCode>
    <emdnDescription>IVD GENERAL USE CONSUMABLE DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>69543760F000376G</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T17:27:00.561Z</lastUpdated>
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    <udiDi>06954376005241</udiDi>
    <basicUdiDi>69543760F000366E</basicUdiDi>
    <tradeName>Sample Diluent 3</tradeName>
    <deviceName>Sample Diluent 3</deviceName>
    <manufacturerName>Beijing Leadman Biochemistry Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000020150</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0599</emdnCode>
    <emdnDescription>IVD GENERAL USE CONSUMABLE DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>69543760F000366E</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T17:27:00.107Z</lastUpdated>
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    <udiDi>06954376005234</udiDi>
    <basicUdiDi>69543760F000356C</basicUdiDi>
    <tradeName>Sample Diluent 2</tradeName>
    <deviceName>Sample Diluent 2</deviceName>
    <manufacturerName>Beijing Leadman Biochemistry Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000020150</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0599</emdnCode>
    <emdnDescription>IVD GENERAL USE CONSUMABLE DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>69543760F000356C</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T17:26:58.960Z</lastUpdated>
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    <udiDi>06954376005227</udiDi>
    <basicUdiDi>69543760F000346A</basicUdiDi>
    <tradeName>Sample Diluent 1</tradeName>
    <deviceName>Sample Diluent 1</deviceName>
    <manufacturerName>Beijing Leadman Biochemistry Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000020150</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0599</emdnCode>
    <emdnDescription>IVD GENERAL USE CONSUMABLE DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>69543760F000346A</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T17:26:58.156Z</lastUpdated>
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    <udiDi>06954376005210</udiDi>
    <basicUdiDi>69543760F0003368</basicUdiDi>
    <tradeName>Concentrated Wash Solution</tradeName>
    <deviceName>Concentrated Wash Solution</deviceName>
    <manufacturerName>Beijing Leadman Biochemistry Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000020150</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0599</emdnCode>
    <emdnDescription>IVD GENERAL USE CONSUMABLE DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>69543760F0003368</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T17:26:54.147Z</lastUpdated>
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    <udiDi>06954376005203</udiDi>
    <basicUdiDi>69543760F0003266</basicUdiDi>
    <tradeName>Wash Solution</tradeName>
    <deviceName>Wash Solution</deviceName>
    <manufacturerName>Beijing Leadman Biochemistry Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000020150</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0599</emdnCode>
    <emdnDescription>IVD GENERAL USE CONSUMABLE DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>69543760F0003266</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T17:26:53.343Z</lastUpdated>
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    <udiDi>05056256106497</udiDi>
    <basicUdiDi>05056256CAH002WT</basicUdiDi>
    <tradeName>CELLEDGE T130 TRIMMING BLADE HANDLE</tradeName>
    <deviceName></deviceName>
    <manufacturerName>CellPath Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000022744</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0580</emdnCode>
    <emdnDescription>IVD GENERAL USE CONSUMABLES DEVICES - OTHER ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CAH-0300-00A</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-31T17:15:20.411Z</lastUpdated>
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    <basicUdiDi>05056256CAH002WT</basicUdiDi>
    <tradeName>CELLEDGE T260 TRIMMING BLADE HANDLE</tradeName>
    <deviceName></deviceName>
    <manufacturerName>CellPath Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000022744</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0580</emdnCode>
    <emdnDescription>IVD GENERAL USE CONSUMABLES DEVICES - OTHER ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CAH-0400-00A</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-31T17:15:20.384Z</lastUpdated>
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