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    <tradeName>06974600430014</tradeName>
    <deviceName>Plastic Full Rim</deviceName>
    <manufacturerName>WENZHOU SENSE OPTICAL CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000009540</manufacturerSrn>
    <authorisedRepresentativeName>Prolinx GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005129</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q02100202</emdnCode>
    <emdnDescription>PLASTIC SPECTACLE FRAMES WITHOUT LENSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Plastic Optical Frame</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-02T13:41:06.618Z</lastUpdated>
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    <udiDi>06974600430021</udiDi>
    <basicUdiDi>697460043FHMPZ</basicUdiDi>
    <tradeName>Optical Frame</tradeName>
    <deviceName>Metal Half Rim</deviceName>
    <manufacturerName>WENZHOU SENSE OPTICAL CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000009540</manufacturerSrn>
    <authorisedRepresentativeName>Prolinx GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005129</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q02100201</emdnCode>
    <emdnDescription>METAL SPECTACLE FRAMES WITHOUT LENSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Metal Optical Frame</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-02T13:41:05.045Z</lastUpdated>
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    <udiDi>06974600430007</udiDi>
    <basicUdiDi>697460043FFMPT</basicUdiDi>
    <tradeName>Optical Frame</tradeName>
    <deviceName>Metal Full Rim</deviceName>
    <manufacturerName>WENZHOU SENSE OPTICAL CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000009540</manufacturerSrn>
    <authorisedRepresentativeName>Prolinx GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005129</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q02100201</emdnCode>
    <emdnDescription>METAL SPECTACLE FRAMES WITHOUT LENSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Metal Optical Frame</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-02T13:40:49.749Z</lastUpdated>
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    <basicUdiDi>697458949DS010001XD</basicUdiDi>
    <tradeName>Surgical Drape</tradeName>
    <deviceName>Surgical Drape</deviceName>
    <manufacturerName>Jiangsu Dingshun Medical Products Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000037429</manufacturerSrn>
    <authorisedRepresentativeName>Prolinx GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005129</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>T020102</emdnCode>
    <emdnDescription>SPECIALISTIC SURGERY DRAPES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DS010001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T13:39:32.843Z</lastUpdated>
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    <udiDi>06974589490566</udiDi>
    <basicUdiDi>697458949DS030001Y3</basicUdiDi>
    <tradeName>Surgical Pack</tradeName>
    <deviceName>Surgical Pack</deviceName>
    <manufacturerName>Jiangsu Dingshun Medical Products Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000037429</manufacturerSrn>
    <authorisedRepresentativeName>Prolinx GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005129</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>DS501</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T13:39:31.266Z</lastUpdated>
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    <udiDi>06974589490078</udiDi>
    <basicUdiDi>697458949DS020001XQ</basicUdiDi>
    <tradeName>Surgical Gown</tradeName>
    <deviceName>Surgical Gown</deviceName>
    <manufacturerName>Jiangsu Dingshun Medical Products Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000037429</manufacturerSrn>
    <authorisedRepresentativeName>Prolinx GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005129</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>T020401</emdnCode>
    <emdnDescription>STANDARD SURGICAL GOWNS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T13:39:30.488Z</lastUpdated>
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    <udiDi>06974589490016</udiDi>
    <basicUdiDi>697458949DS050001YR</basicUdiDi>
    <tradeName>Surgical Stockinette</tradeName>
    <deviceName>Surgical Stockinette</deviceName>
    <manufacturerName>Jiangsu Dingshun Medical Products Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000037429</manufacturerSrn>
    <authorisedRepresentativeName>Prolinx GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005129</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>M03030202</emdnCode>
    <emdnDescription>SKIN PROTECTIVE BANDAGES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T13:39:28.842Z</lastUpdated>
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    <udiDi>06974435053556</udiDi>
    <basicUdiDi>697443505P03PC</basicUdiDi>
    <tradeName>06974435053556</tradeName>
    <deviceName>Orthodontic Elastomeric Auxiliaries</deviceName>
    <manufacturerName>CREATIVE DENTAL</manufacturerName>
    <manufacturerSrn>CN-MF-000025975</manufacturerSrn>
    <authorisedRepresentativeName>Prolinx GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005129</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q010404</emdnCode>
    <emdnDescription>ORTHODONTIC ELASTICS, CHAINS AND SPRINGS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Elastolink chain long neon purple</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-02T13:06:47.782Z</lastUpdated>
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    <udiDi>06974435053167</udiDi>
    <basicUdiDi>697443505P02PA</basicUdiDi>
    <tradeName>Orthodontic Elastomeric Auxiliaries</tradeName>
    <deviceName>Orthodontic Elastomeric Auxiliaries</deviceName>
    <manufacturerName>CREATIVE DENTAL</manufacturerName>
    <manufacturerSrn>CN-MF-000025975</manufacturerSrn>
    <authorisedRepresentativeName>Prolinx GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005129</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q010404</emdnCode>
    <emdnDescription>ORTHODONTIC ELASTICS, CHAINS AND SPRINGS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Elastomeric separator</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-02T13:06:43.788Z</lastUpdated>
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    <udiDi>06974435050623</udiDi>
    <basicUdiDi>697443505P01P8</basicUdiDi>
    <tradeName>Orthodontic Elastomeric Auxiliaries</tradeName>
    <deviceName>Orthodontic Elastomeric Auxiliaries</deviceName>
    <manufacturerName>CREATIVE DENTAL</manufacturerName>
    <manufacturerSrn>CN-MF-000025975</manufacturerSrn>
    <authorisedRepresentativeName>Prolinx GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005129</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q010404</emdnCode>
    <emdnDescription>ORTHODONTIC ELASTICS, CHAINS AND SPRINGS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Elastomeric Intra-oral Elastics  5/16</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-02T13:06:42.967Z</lastUpdated>
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    <udiDi>06974435050395</udiDi>
    <basicUdiDi>697443505AW05JD</basicUdiDi>
    <tradeName>Orthodontic Archwire</tradeName>
    <deviceName>Orthodontic Archwires</deviceName>
    <manufacturerName>CREATIVE DENTAL</manufacturerName>
    <manufacturerSrn>CN-MF-000025975</manufacturerSrn>
    <authorisedRepresentativeName>Prolinx GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005129</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q010405</emdnCode>
    <emdnDescription>ORTHODONTIC WIRES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Stainless steel archwire 013 lower</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-02T13:06:35.799Z</lastUpdated>
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    <udiDi>06942665515328</udiDi>
    <basicUdiDi>697443505CR010CH</basicUdiDi>
    <tradeName>Orthodontic Ceramic Brackets</tradeName>
    <deviceName>Orthodontic Ceramic Brackets</deviceName>
    <manufacturerName>CREATIVE DENTAL</manufacturerName>
    <manufacturerSrn>CN-MF-000025975</manufacturerSrn>
    <authorisedRepresentativeName>Prolinx GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005129</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q010403</emdnCode>
    <emdnDescription>ORTHODONTIC BRACKETS AND BUTTONS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Noble, Roth 0.018" 3 hooks</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-02T13:04:33.986Z</lastUpdated>
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    <udiDi>06942665514949</udiDi>
    <basicUdiDi>697443505CR011CK</basicUdiDi>
    <tradeName>Orthodontic Ceramic Brackets</tradeName>
    <deviceName>Orthodontic Ceramic Brackets</deviceName>
    <manufacturerName>CREATIVE DENTAL</manufacturerName>
    <manufacturerSrn>CN-MF-000025975</manufacturerSrn>
    <authorisedRepresentativeName>Prolinx GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005129</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q010403</emdnCode>
    <emdnDescription>ORTHODONTIC BRACKETS AND BUTTONS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Noble, MBT 0.018" 3 hooks</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-02T13:04:33.201Z</lastUpdated>
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    <udiDi>08595566429997</udiDi>
    <basicUdiDi>697442359CP12KD</basicUdiDi>
    <tradeName>Dr. Max Cooling Patches</tradeName>
    <deviceName>Cooling Patch</deviceName>
    <manufacturerName>Koolcare Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000017687</manufacturerSrn>
    <authorisedRepresentativeName>Prolinx GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005129</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z120602</emdnCode>
    <emdnDescription>PHYSIOTHERAPY EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KK-II-CP-2</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-02T13:02:24.245Z</lastUpdated>
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    <udiDi>06974423592302</udiDi>
    <basicUdiDi>697442359ICBS3</basicUdiDi>
    <tradeName>06974423592302</tradeName>
    <deviceName>Instant Cold Pack</deviceName>
    <manufacturerName>Koolcare Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000017687</manufacturerSrn>
    <authorisedRepresentativeName>Prolinx GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005129</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>M030504</emdnCode>
    <emdnDescription>IMMOBILISATION SYSTEMS, MOULDABLE UNDER COLD AND HOT TEMPRATURES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KK-IC-B 230</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T13:00:03.264Z</lastUpdated>
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    <basicUdiDi>697442359ICARZ</basicUdiDi>
    <tradeName>06974423592005</tradeName>
    <deviceName>Instant Cold Pack</deviceName>
    <manufacturerName>Koolcare Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000017687</manufacturerSrn>
    <authorisedRepresentativeName>Prolinx GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005129</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>M030504</emdnCode>
    <emdnDescription>IMMOBILISATION SYSTEMS, MOULDABLE UNDER COLD AND HOT TEMPRATURES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KK-IC-B 200</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T13:00:02.443Z</lastUpdated>
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    <basicUdiDi>697442359RPAUM</basicUdiDi>
    <tradeName>06974423590049</tradeName>
    <deviceName>Cold/Hot Pack</deviceName>
    <manufacturerName>Koolcare Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000017687</manufacturerSrn>
    <authorisedRepresentativeName>Prolinx GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005129</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>M030504</emdnCode>
    <emdnDescription>IMMOBILISATION SYSTEMS, MOULDABLE UNDER COLD AND HOT TEMPRATURES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KK-RP-CH</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-02T13:00:00.852Z</lastUpdated>
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    <udiDi>04042441017380</udiDi>
    <basicUdiDi>697442359IWN45P6</basicUdiDi>
    <tradeName>Mivolis Waermepflaster</tradeName>
    <deviceName>Heat Wraps</deviceName>
    <manufacturerName>Koolcare Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000017687</manufacturerSrn>
    <authorisedRepresentativeName>Prolinx GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005129</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z120602</emdnCode>
    <emdnDescription>PHYSIOTHERAPY EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>533 163/0</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T12:54:33.979Z</lastUpdated>
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    <udiDi>06973855830532</udiDi>
    <basicUdiDi>697385583BPAP01RD</basicUdiDi>
    <tradeName>TOPSONMED, SS130</tradeName>
    <deviceName>Continuous Positive Airway Pressure Devices</deviceName>
    <manufacturerName>Hebei Topson Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000024553</manufacturerSrn>
    <authorisedRepresentativeName>Prolinx GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005129</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12030102</emdnCode>
    <emdnDescription>CONTINUOUS POSITIVE PRESSURE EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SS130</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-02T12:05:13.835Z</lastUpdated>
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    <udiDi>06973855830495</udiDi>
    <basicUdiDi>697385583CPAP01RS</basicUdiDi>
    <tradeName>TOPSONMED, SS100</tradeName>
    <deviceName>Continuous Positive Airway Pressure Devices</deviceName>
    <manufacturerName>Hebei Topson Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000024553</manufacturerSrn>
    <authorisedRepresentativeName>Prolinx GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005129</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12030102</emdnCode>
    <emdnDescription>CONTINUOUS POSITIVE PRESSURE EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SS100</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-02T12:05:09.837Z</lastUpdated>
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