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    <tradeName>Asahi KASEI</tradeName>
    <deviceName>Disposable A.V. Fistula Needle Sets</deviceName>
    <manufacturerName>Bain Medical Equipment(Guangzhou)Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005196</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A010401</emdnCode>
    <emdnDescription>ARTERIOVENOUS FISTULA NEEDLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AVF-BR2530BG-17</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T17:20:00.233Z</lastUpdated>
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    <udiDi>06948082721557</udiDi>
    <basicUdiDi>B-06948082721557</basicUdiDi>
    <tradeName>Asahi KASEI</tradeName>
    <deviceName>Disposable A.V. Fistula Needle Sets</deviceName>
    <manufacturerName>Bain Medical Equipment(Guangzhou)Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005196</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A010401</emdnCode>
    <emdnDescription>ARTERIOVENOUS FISTULA NEEDLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AVF-BR2530GP-16</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T17:20:00.203Z</lastUpdated>
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    <udiDi>06948082721564</udiDi>
    <basicUdiDi>B-06948082721564</basicUdiDi>
    <tradeName>Asahi KASEI</tradeName>
    <deviceName>Disposable A.V. Fistula Needle Sets(Dull needle series)</deviceName>
    <manufacturerName>Bain Medical Equipment(Guangzhou)Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005196</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A010401</emdnCode>
    <emdnDescription>ARTERIOVENOUS FISTULA NEEDLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AVF-D-BR2530BGDS-15</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T17:20:00.189Z</lastUpdated>
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    <udiDi>06948082721571</udiDi>
    <basicUdiDi>B-06948082721571</basicUdiDi>
    <tradeName>Asahi KASEI</tradeName>
    <deviceName>Disposable A.V. Fistula Needle Sets(Dull needle series)</deviceName>
    <manufacturerName>Bain Medical Equipment(Guangzhou)Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005196</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A010401</emdnCode>
    <emdnDescription>ARTERIOVENOUS FISTULA NEEDLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AVF-D-BR2530BGDS-17</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T17:20:00.174Z</lastUpdated>
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    <udiDi>06948082746222</udiDi>
    <basicUdiDi>B-06948082746222</basicUdiDi>
    <tradeName>DORA</tradeName>
    <deviceName>Disposable A.V. Fistula Needle Sets</deviceName>
    <manufacturerName>Bain Medical Equipment(Guangzhou)Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005196</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A010401</emdnCode>
    <emdnDescription>ARTERIOVENOUS FISTULA NEEDLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BAIN-A.V.F-026AE</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T17:20:00.129Z</lastUpdated>
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  <row>
    <udiDi>06948082750175</udiDi>
    <basicUdiDi>B-06948082750175</basicUdiDi>
    <tradeName>DORA</tradeName>
    <deviceName>Disposable A.V. Fistula Needle Sets</deviceName>
    <manufacturerName>Bain Medical Equipment(Guangzhou)Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005196</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A010401</emdnCode>
    <emdnDescription>ARTERIOVENOUS FISTULA NEEDLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BAIN-A.V.F-058AG</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-30T17:19:59.903Z</lastUpdated>
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    <udiDi>06948082750182</udiDi>
    <basicUdiDi>B-06948082750182</basicUdiDi>
    <tradeName>DORA</tradeName>
    <deviceName>Disposable A.V. Fistula Needle Sets</deviceName>
    <manufacturerName>Bain Medical Equipment(Guangzhou)Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005196</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A010401</emdnCode>
    <emdnDescription>ARTERIOVENOUS FISTULA NEEDLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BAIN-A.V.F-058VG</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-30T17:19:59.879Z</lastUpdated>
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    <udiDi>06948082750946</udiDi>
    <basicUdiDi>B-06948082750946</basicUdiDi>
    <tradeName>DORA</tradeName>
    <deviceName>Disposable A.V. Fistula Needle Sets(Dull needle series)</deviceName>
    <manufacturerName>Bain Medical Equipment(Guangzhou)Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005196</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A010401</emdnCode>
    <emdnDescription>ARTERIOVENOUS FISTULA NEEDLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BAIN-A.V.F-078DE</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-30T17:19:59.857Z</lastUpdated>
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    <udiDi>06948082751035</udiDi>
    <basicUdiDi>B-06948082751035</basicUdiDi>
    <tradeName>DORA</tradeName>
    <deviceName>Disposable A.V. Fistula Needle Sets</deviceName>
    <manufacturerName>Bain Medical Equipment(Guangzhou)Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005196</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A010401</emdnCode>
    <emdnDescription>ARTERIOVENOUS FISTULA NEEDLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BAIN-A.V.F-086E</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-30T17:19:59.780Z</lastUpdated>
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  <row>
    <udiDi>06948082751042</udiDi>
    <basicUdiDi>B-06948082751042</basicUdiDi>
    <tradeName>DORA</tradeName>
    <deviceName>Disposable A.V. Fistula Needle Sets(Dull needle series)</deviceName>
    <manufacturerName>Bain Medical Equipment(Guangzhou)Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005196</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A010401</emdnCode>
    <emdnDescription>ARTERIOVENOUS FISTULA NEEDLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BAIN-A.V.F-050DE</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-30T17:19:59.747Z</lastUpdated>
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    <udiDi>06948082751059</udiDi>
    <basicUdiDi>B-06948082751059</basicUdiDi>
    <tradeName>DORA</tradeName>
    <deviceName>Disposable A.V. Fistula Needle Sets(Dull needle series)</deviceName>
    <manufacturerName>Bain Medical Equipment(Guangzhou)Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005196</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A010401</emdnCode>
    <emdnDescription>ARTERIOVENOUS FISTULA NEEDLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BAIN-A.V.F-070DE</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-30T17:19:59.717Z</lastUpdated>
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  <row>
    <udiDi>06948082751097</udiDi>
    <basicUdiDi>B-06948082751097</basicUdiDi>
    <tradeName>DORA</tradeName>
    <deviceName>Disposable A.V. Fistula Needle Sets</deviceName>
    <manufacturerName>Bain Medical Equipment(Guangzhou)Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005196</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A010401</emdnCode>
    <emdnDescription>ARTERIOVENOUS FISTULA NEEDLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BAIN-A.V.F-088TE</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T17:19:59.671Z</lastUpdated>
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  <row>
    <udiDi>06948082751103</udiDi>
    <basicUdiDi>B-06948082751103</basicUdiDi>
    <tradeName>DORA</tradeName>
    <deviceName>Disposable A.V. Fistula Needle Sets</deviceName>
    <manufacturerName>Bain Medical Equipment(Guangzhou)Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005196</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A010401</emdnCode>
    <emdnDescription>ARTERIOVENOUS FISTULA NEEDLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BAIN-A.V.F-038TE</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-30T17:19:59.643Z</lastUpdated>
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    <udiDi>06948082751110</udiDi>
    <basicUdiDi>B-06948082751110</basicUdiDi>
    <tradeName>DORA</tradeName>
    <deviceName>Disposable A.V. Fistula Needle Sets</deviceName>
    <manufacturerName>Bain Medical Equipment(Guangzhou)Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005196</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A010401</emdnCode>
    <emdnDescription>ARTERIOVENOUS FISTULA NEEDLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BAIN-A.V.F-092TE</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T17:19:59.616Z</lastUpdated>
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    <udiDi>06948082751127</udiDi>
    <basicUdiDi>B-06948082751127</basicUdiDi>
    <tradeName>DORA</tradeName>
    <deviceName>Disposable A.V. Fistula Needle Sets</deviceName>
    <manufacturerName>Bain Medical Equipment(Guangzhou)Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005196</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A010401</emdnCode>
    <emdnDescription>ARTERIOVENOUS FISTULA NEEDLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BAIN-A.V.F-046TE</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-30T17:19:59.594Z</lastUpdated>
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    <udiDi>06948082751950</udiDi>
    <basicUdiDi>6948082720282AU</basicUdiDi>
    <tradeName>DORA Fistula Catheter</tradeName>
    <deviceName>Fistula Catheter</deviceName>
    <manufacturerName>Bain Medical Equipment(Guangzhou)Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005196</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A010401</emdnCode>
    <emdnDescription>ARTERIOVENOUS FISTULA NEEDLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BAIN-FC-003</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T17:19:59.489Z</lastUpdated>
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    <udiDi>06948082770074</udiDi>
    <basicUdiDi>B-06948082770074</basicUdiDi>
    <tradeName>DORA</tradeName>
    <deviceName>Disposable A.V. Fistula Needle Sets (Safety Needle series)</deviceName>
    <manufacturerName>Bain Medical Equipment(Guangzhou)Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005196</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A010401</emdnCode>
    <emdnDescription>ARTERIOVENOUS FISTULA NEEDLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BAIN-A.V.F-034SE</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-30T17:19:59.422Z</lastUpdated>
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    <udiDi>06948082770081</udiDi>
    <basicUdiDi>B-06948082770081</basicUdiDi>
    <tradeName>DORA</tradeName>
    <deviceName>Disposable A.V. Fistula Needle Sets (Safety Needle series)</deviceName>
    <manufacturerName>Bain Medical Equipment(Guangzhou)Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005196</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A010401</emdnCode>
    <emdnDescription>ARTERIOVENOUS FISTULA NEEDLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BAIN-A.V.F-086SE</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-30T17:19:59.402Z</lastUpdated>
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    <udiDi>06948082770098</udiDi>
    <basicUdiDi>B-06948082770098</basicUdiDi>
    <tradeName>DORA</tradeName>
    <deviceName>Disposable A.V. Fistula Needle Sets (Safety Needle series)</deviceName>
    <manufacturerName>Bain Medical Equipment(Guangzhou)Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005196</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A010401</emdnCode>
    <emdnDescription>ARTERIOVENOUS FISTULA NEEDLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BAIN-A.V.F-026SE</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-30T17:19:59.367Z</lastUpdated>
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    <udiDi>06948082770104</udiDi>
    <basicUdiDi>B-06948082770104</basicUdiDi>
    <tradeName>DORA</tradeName>
    <deviceName>Disposable A.V. Fistula Needle Sets (Safety Needle series)</deviceName>
    <manufacturerName>Bain Medical Equipment(Guangzhou)Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005196</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A010401</emdnCode>
    <emdnDescription>ARTERIOVENOUS FISTULA NEEDLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BAIN-A.V.F-090SE</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-30T17:19:59.349Z</lastUpdated>
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