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    <basicUdiDi>697541776004014J</basicUdiDi>
    <tradeName>Wash Reagent</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hotgen (Langfang) Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000018899</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01029099</emdnCode>
    <emdnDescription>IMMUNOCHEMISTRY REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HGOTHER08</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T09:31:43.096Z</lastUpdated>
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    <udiDi>06975417769496</udiDi>
    <basicUdiDi>697541776005MQ</basicUdiDi>
    <tradeName>Substrate Module</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hotgen (Langfang) Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000018899</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01029099</emdnCode>
    <emdnDescription>IMMUNOCHEMISTRY REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HGOTHER03</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T09:31:43.076Z</lastUpdated>
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    <udiDi>06975417769502</udiDi>
    <basicUdiDi>697541776005MQ</basicUdiDi>
    <tradeName>Substrate Module</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hotgen (Langfang) Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000018899</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01029099</emdnCode>
    <emdnDescription>IMMUNOCHEMISTRY REAGENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HGOTHER04</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T09:31:43.064Z</lastUpdated>
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    <udiDi>06975420309023</udiDi>
    <basicUdiDi>697542030AFTBGW</basicUdiDi>
    <tradeName>Air Fluidized Therapy Bed</tradeName>
    <deviceName></deviceName>
    <manufacturerName>NINGBO DENGHUANG MEDICAL EQUIPMENT CO.,LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000048189</manufacturerSrn>
    <authorisedRepresentativeName>MedPath GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000087</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>V08060104</emdnCode>
    <emdnDescription>BURN PATIENT ELECTRIC MEDICAL BEDS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>YXFCH-XB type</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T09:31:42.980Z</lastUpdated>
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  <row>
    <udiDi>06975420309054</udiDi>
    <basicUdiDi>697542030AFTBGW</basicUdiDi>
    <tradeName>Air Fluidized Therapy Bed</tradeName>
    <deviceName></deviceName>
    <manufacturerName>NINGBO DENGHUANG MEDICAL EQUIPMENT CO.,LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000048189</manufacturerSrn>
    <authorisedRepresentativeName>MedPath GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000087</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>V08060104</emdnCode>
    <emdnDescription>BURN PATIENT ELECTRIC MEDICAL BEDS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>YXFCH-XC type</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T09:31:42.959Z</lastUpdated>
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  <row>
    <udiDi>06975424072046</udiDi>
    <basicUdiDi>697542407167KP</basicUdiDi>
    <tradeName>AUTO KERATO/REFRACTOMETER</tradeName>
    <deviceName></deviceName>
    <manufacturerName>NINGBO FLO OPTICAL TECHNOLOGY DEVELOPMENT CO.,LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000008703</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q0299</emdnCode>
    <emdnDescription>OPHTHALMIC DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FR-8900</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T09:31:42.536Z</lastUpdated>
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  <row>
    <udiDi>06975424072923</udiDi>
    <basicUdiDi>697542407167KP</basicUdiDi>
    <tradeName>AUTO KERATO/REFRACTOMETER</tradeName>
    <deviceName></deviceName>
    <manufacturerName>NINGBO FLO OPTICAL TECHNOLOGY DEVELOPMENT CO.,LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000008703</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q0299</emdnCode>
    <emdnDescription>OPHTHALMIC DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FKR-8900</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T09:31:42.518Z</lastUpdated>
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  <row>
    <udiDi>06975424076358</udiDi>
    <basicUdiDi>697542407167KP</basicUdiDi>
    <tradeName>AUTO KERATO/REFRACTOMETER</tradeName>
    <deviceName></deviceName>
    <manufacturerName>NINGBO FLO OPTICAL TECHNOLOGY DEVELOPMENT CO.,LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000008703</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q0299</emdnCode>
    <emdnDescription>OPHTHALMIC DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FR-900</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T09:31:42.500Z</lastUpdated>
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  <row>
    <udiDi>06975424077881</udiDi>
    <basicUdiDi>697542407167KP</basicUdiDi>
    <tradeName>AUTO KERATO/REFRACTOMETER</tradeName>
    <deviceName></deviceName>
    <manufacturerName>NINGBO FLO OPTICAL TECHNOLOGY DEVELOPMENT CO.,LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000008703</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q0299</emdnCode>
    <emdnDescription>OPHTHALMIC DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FR-710</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T09:31:42.481Z</lastUpdated>
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  <row>
    <udiDi>06975424078383</udiDi>
    <basicUdiDi>697542407167KP</basicUdiDi>
    <tradeName>AUTO KERATO/REFRACTOMETER</tradeName>
    <deviceName></deviceName>
    <manufacturerName>NINGBO FLO OPTICAL TECHNOLOGY DEVELOPMENT CO.,LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000008703</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q0299</emdnCode>
    <emdnDescription>OPHTHALMIC DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FKR-900</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T09:31:42.462Z</lastUpdated>
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    <udiDi>06975424190566</udiDi>
    <basicUdiDi>697542419SP05NS</basicUdiDi>
    <tradeName>Probe cover kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Exact Medical Manufacturing, Inc</manufacturerName>
    <manufacturerSrn>CN-MF-000001406</manufacturerSrn>
    <authorisedRepresentativeName>Exact Medical Manufacturing B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000452</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>T0202</emdnCode>
    <emdnDescription>SURGICAL PROCEDURAL KITS (EXCLUDING SURGICAL INSTRUMENT KITS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P6450</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T09:31:42.427Z</lastUpdated>
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    <udiDi>06975424190573</udiDi>
    <basicUdiDi>697542419SP05NS</basicUdiDi>
    <tradeName>Probe cover kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Exact Medical Manufacturing, Inc</manufacturerName>
    <manufacturerSrn>CN-MF-000001406</manufacturerSrn>
    <authorisedRepresentativeName>Exact Medical Manufacturing B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000452</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>T0202</emdnCode>
    <emdnDescription>SURGICAL PROCEDURAL KITS (EXCLUDING SURGICAL INSTRUMENT KITS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P6449</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T09:31:42.409Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975424190580</udiDi>
    <basicUdiDi>697542419SP05NS</basicUdiDi>
    <tradeName>Probe cover kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Exact Medical Manufacturing, Inc</manufacturerName>
    <manufacturerSrn>CN-MF-000001406</manufacturerSrn>
    <authorisedRepresentativeName>Exact Medical Manufacturing B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000452</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>T0202</emdnCode>
    <emdnDescription>SURGICAL PROCEDURAL KITS (EXCLUDING SURGICAL INSTRUMENT KITS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P6435A</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T09:31:42.391Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975424190597</udiDi>
    <basicUdiDi>697542419SP05NS</basicUdiDi>
    <tradeName>Probe cover kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Exact Medical Manufacturing, Inc</manufacturerName>
    <manufacturerSrn>CN-MF-000001406</manufacturerSrn>
    <authorisedRepresentativeName>Exact Medical Manufacturing B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000452</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>T0202</emdnCode>
    <emdnDescription>SURGICAL PROCEDURAL KITS (EXCLUDING SURGICAL INSTRUMENT KITS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P6432</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T09:31:42.368Z</lastUpdated>
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    <udiDi>06975424190603</udiDi>
    <basicUdiDi>697542419SP05NS</basicUdiDi>
    <tradeName>Probe cover kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Exact Medical Manufacturing, Inc</manufacturerName>
    <manufacturerSrn>CN-MF-000001406</manufacturerSrn>
    <authorisedRepresentativeName>Exact Medical Manufacturing B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000452</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>T0202</emdnCode>
    <emdnDescription>SURGICAL PROCEDURAL KITS (EXCLUDING SURGICAL INSTRUMENT KITS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P6430</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T09:31:42.346Z</lastUpdated>
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    <udiDi>06975424190610</udiDi>
    <basicUdiDi>697542419SP05NS</basicUdiDi>
    <tradeName>Probe cover kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Exact Medical Manufacturing, Inc</manufacturerName>
    <manufacturerSrn>CN-MF-000001406</manufacturerSrn>
    <authorisedRepresentativeName>Exact Medical Manufacturing B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000452</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>T0202</emdnCode>
    <emdnDescription>SURGICAL PROCEDURAL KITS (EXCLUDING SURGICAL INSTRUMENT KITS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P6418</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T09:31:42.329Z</lastUpdated>
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    <udiDi>06975424190627</udiDi>
    <basicUdiDi>697542419SP05NS</basicUdiDi>
    <tradeName>Probe cover kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Exact Medical Manufacturing, Inc</manufacturerName>
    <manufacturerSrn>CN-MF-000001406</manufacturerSrn>
    <authorisedRepresentativeName>Exact Medical Manufacturing B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000452</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>T0202</emdnCode>
    <emdnDescription>SURGICAL PROCEDURAL KITS (EXCLUDING SURGICAL INSTRUMENT KITS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P6413</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T09:31:42.314Z</lastUpdated>
  </row>
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    <udiDi>06975424190634</udiDi>
    <basicUdiDi>697542419SP05NS</basicUdiDi>
    <tradeName>Probe cover kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Exact Medical Manufacturing, Inc</manufacturerName>
    <manufacturerSrn>CN-MF-000001406</manufacturerSrn>
    <authorisedRepresentativeName>Exact Medical Manufacturing B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000452</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>T0202</emdnCode>
    <emdnDescription>SURGICAL PROCEDURAL KITS (EXCLUDING SURGICAL INSTRUMENT KITS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P6403</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T09:31:42.303Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975424190641</udiDi>
    <basicUdiDi>697542419SP05NS</basicUdiDi>
    <tradeName>Probe cover kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Exact Medical Manufacturing, Inc</manufacturerName>
    <manufacturerSrn>CN-MF-000001406</manufacturerSrn>
    <authorisedRepresentativeName>Exact Medical Manufacturing B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000452</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>T0202</emdnCode>
    <emdnDescription>SURGICAL PROCEDURAL KITS (EXCLUDING SURGICAL INSTRUMENT KITS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P6345</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T09:31:42.294Z</lastUpdated>
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  <row>
    <udiDi>06975424190658</udiDi>
    <basicUdiDi>697542419SP05NS</basicUdiDi>
    <tradeName>Probe cover kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Exact Medical Manufacturing, Inc</manufacturerName>
    <manufacturerSrn>CN-MF-000001406</manufacturerSrn>
    <authorisedRepresentativeName>Exact Medical Manufacturing B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000452</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>T0202</emdnCode>
    <emdnDescription>SURGICAL PROCEDURAL KITS (EXCLUDING SURGICAL INSTRUMENT KITS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P6339G</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T09:31:42.285Z</lastUpdated>
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