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    <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-084TE</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-28T00:11:51.322Z</lastUpdated>
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    <basicUdiDi>B-06948082774348</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>
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    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
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    <emdnDescription>ARTERIOVENOUS FISTULA NEEDLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-28T00:11:50.129Z</lastUpdated>
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    <udiDi>06948082774331</udiDi>
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    <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>
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    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A010401</emdnCode>
    <emdnDescription>ARTERIOVENOUS FISTULA NEEDLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-28T00:11:48.922Z</lastUpdated>
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    <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-082AE</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-28T00:11:42.934Z</lastUpdated>
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    <udiDi>06948082774317</udiDi>
    <basicUdiDi>B-06948082774317</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-090AE</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-28T00:11:41.718Z</lastUpdated>
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    <udiDi>06948082773976</udiDi>
    <basicUdiDi>6948082722082AY</basicUdiDi>
    <tradeName>DORA</tradeName>
    <deviceName>Apheresis Needle</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>A010199</emdnCode>
    <emdnDescription>NEEDLES FOR INFUSION AND COLLECTION - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>7R2462</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-28T00:11:40.573Z</lastUpdated>
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    <udiDi>06948082773150</udiDi>
    <basicUdiDi>B-06948082773150</basicUdiDi>
    <tradeName>EOS</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>
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    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A010401</emdnCode>
    <emdnDescription>ARTERIOVENOUS FISTULA NEEDLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EOS323212-A(BAIN-A.V.F-088TE)</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-28T00:11:39.311Z</lastUpdated>
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    <tradeName>EOS</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>
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    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A010401</emdnCode>
    <emdnDescription>ARTERIOVENOUS FISTULA NEEDLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EOS313212-A(BAIN-A.V.F-092TE)</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-28T00:11:33.326Z</lastUpdated>
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    <udiDi>06948082773136</udiDi>
    <basicUdiDi>B-06948082773136</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-088VE</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-28T00:11:32.136Z</lastUpdated>
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    <udiDi>06948082773129</udiDi>
    <basicUdiDi>B-06948082773129</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-086AE</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-28T00:11:30.906Z</lastUpdated>
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    <udiDi>06948082773006</udiDi>
    <basicUdiDi>B-06948082773006</basicUdiDi>
    <tradeName>DORA</tradeName>
    <deviceName>Tubing Sets for Hemodialysis</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>F020102</emdnCode>
    <emdnDescription>ARTERIOVENOUS DIALYSIS LINES, TWO NEEDLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BAIN-BL-109E</reference>
    <placedOnMarketCountry>Latvia</placedOnMarketCountry>
    <lastUpdated>2026-06-28T00:11:29.716Z</lastUpdated>
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    <udiDi>06948082772993</udiDi>
    <basicUdiDi>B-06948082772993</basicUdiDi>
    <tradeName>DORA</tradeName>
    <deviceName>Tubing Sets for Hemodialysis</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>F020102</emdnCode>
    <emdnDescription>ARTERIOVENOUS DIALYSIS LINES, TWO NEEDLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BAIN-BL-110E</reference>
    <placedOnMarketCountry>Latvia</placedOnMarketCountry>
    <lastUpdated>2026-06-28T00:11:23.760Z</lastUpdated>
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    <udiDi>06948082772979</udiDi>
    <basicUdiDi>6948082722082AY</basicUdiDi>
    <tradeName>DORA</tradeName>
    <deviceName>Apheresis Needle</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>A010199</emdnCode>
    <emdnDescription>NEEDLES FOR INFUSION AND COLLECTION - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>7R2461</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-28T00:11:22.497Z</lastUpdated>
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    <udiDi>06948082772962</udiDi>
    <basicUdiDi>6948082722082AY</basicUdiDi>
    <tradeName>DORA</tradeName>
    <deviceName>Apheresis Needle</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>A010199</emdnCode>
    <emdnDescription>NEEDLES FOR INFUSION AND COLLECTION - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>7R2460</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-28T00:11:21.754Z</lastUpdated>
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    <udiDi>06948082772061</udiDi>
    <basicUdiDi>B-06948082772061</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-030AE</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-28T00:11:20.250Z</lastUpdated>
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    <udiDi>06948082771958</udiDi>
    <basicUdiDi>B-06948082771958</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-BR2530G-15</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-28T00:11:14.118Z</lastUpdated>
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    <basicUdiDi>B-06948082771941</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-BR2530G-17</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-28T00:11:13.277Z</lastUpdated>
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    <udiDi>06948082771637</udiDi>
    <basicUdiDi>B-06948082771637</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-086DE</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-06-28T00:11:11.755Z</lastUpdated>
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    <basicUdiDi>B-06948082771569</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-006SE</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-28T00:11:10.521Z</lastUpdated>
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    <udiDi>06948082771521</udiDi>
    <basicUdiDi>B-06948082771521</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-036DE</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-06-28T00:11:04.768Z</lastUpdated>
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