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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-050E</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-30T17:20:00.861Z</lastUpdated>
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    <udiDi>06948082709425</udiDi>
    <basicUdiDi>B-06948082709425</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-070E</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-30T17:20:00.838Z</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-074E</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-30T17:20:00.823Z</lastUpdated>
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    <basicUdiDi>B-06948082709449</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-078E</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-30T17:20:00.805Z</lastUpdated>
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    <udiDi>06948082709456</udiDi>
    <basicUdiDi>B-06948082709456</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-090E</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-30T17:20:00.790Z</lastUpdated>
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    <udiDi>06948082709463</udiDi>
    <basicUdiDi>B-06948082709463</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-002SE</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-30T17:20:00.779Z</lastUpdated>
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    <udiDi>06948082709470</udiDi>
    <basicUdiDi>B-06948082709470</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>
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    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A010401</emdnCode>
    <emdnDescription>ARTERIOVENOUS FISTULA NEEDLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BAIN-A.V.F-010SE</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-30T17:20:00.763Z</lastUpdated>
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    <udiDi>06948082709487</udiDi>
    <basicUdiDi>B-06948082709487</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-050SE</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-30T17:20:00.739Z</lastUpdated>
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    <udiDi>06948082709494</udiDi>
    <basicUdiDi>B-06948082709494</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-066SE</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-30T17:20:00.716Z</lastUpdated>
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    <udiDi>06948082709500</udiDi>
    <basicUdiDi>B-06948082709500</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-070SE</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-30T17:20:00.699Z</lastUpdated>
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    <udiDi>06948082709517</udiDi>
    <basicUdiDi>B-06948082709517</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-074SE</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-30T17:20:00.674Z</lastUpdated>
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    <udiDi>06948082709685</udiDi>
    <basicUdiDi>B-06948082709685</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-BR2530BG-16</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T17:20:00.636Z</lastUpdated>
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    <udiDi>06948082709692</udiDi>
    <basicUdiDi>B-06948082709692</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-BR2530BGP-15</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T17:20:00.619Z</lastUpdated>
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    <udiDi>06948082709708</udiDi>
    <basicUdiDi>B-06948082709708</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-BR2530BGP-16</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T17:20:00.592Z</lastUpdated>
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    <udiDi>06948082709715</udiDi>
    <basicUdiDi>B-06948082709715</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-BR2530BGP-17</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T17:20:00.573Z</lastUpdated>
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    <udiDi>06948082710568</udiDi>
    <basicUdiDi>B-06948082710568</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-010DE</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-30T17:20:00.460Z</lastUpdated>
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    <udiDi>06948082710575</udiDi>
    <basicUdiDi>B-06948082710575</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-074DE</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-30T17:20:00.441Z</lastUpdated>
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    <udiDi>06948082710896</udiDi>
    <basicUdiDi>B-06948082710896</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-16</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T17:20:00.373Z</lastUpdated>
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    <udiDi>06948082721519</udiDi>
    <basicUdiDi>B-06948082721519</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-16</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T17:20:00.266Z</lastUpdated>
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    <udiDi>06948082721526</udiDi>
    <basicUdiDi>B-06948082721526</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-BR2515G-17</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T17:20:00.251Z</lastUpdated>
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