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    <manufacturerName>BIOSINTEX SRL</manufacturerName>
    <manufacturerSrn>RO-MF-000001463</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
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    <reference>BX6008</reference>
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    <lastUpdated>2026-08-02T22:39:42.437Z</lastUpdated>
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    <basicUdiDi>B-06941173308200</basicUdiDi>
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    <manufacturerName>Jiangsu BANA Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025963</manufacturerSrn>
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    <authorisedRepresentativeSrn>DE-AR-000005946</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
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    <emdnDescription>STAPLERS, VIDEOSURGERY - OTHER</emdnDescription>
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    <reference>LW-350</reference>
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    <manufacturerName>Jiangsu BANA Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025963</manufacturerSrn>
    <authorisedRepresentativeName>Caretechion GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005946</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>H03020101</emdnCode>
    <emdnDescription>SINGLE-USE MULTIPLE CLIP APPLIERS FOR VIDEOSURGERY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TQ10-J</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-02T22:39:42.049Z</lastUpdated>
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    <manufacturerName>BIOSINTEX SRL</manufacturerName>
    <manufacturerSrn>RO-MF-000001463</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>H010201020101</emdnCode>
    <emdnDescription>POLYAMIDE MULTIFILAMENT WITH NEEDLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BX6007</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-08-02T22:39:41.674Z</lastUpdated>
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    <tradeName>BIONIL MULTIx</tradeName>
    <deviceName>BIONIL MULTIx</deviceName>
    <manufacturerName>BIOSINTEX SRL</manufacturerName>
    <manufacturerSrn>RO-MF-000001463</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>H010201020101</emdnCode>
    <emdnDescription>POLYAMIDE MULTIFILAMENT WITH NEEDLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BX6006</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-08-02T22:39:37.658Z</lastUpdated>
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    <tradeName>BIONIL MULTIx</tradeName>
    <deviceName>BIONIL MULTIx</deviceName>
    <manufacturerName>BIOSINTEX SRL</manufacturerName>
    <manufacturerSrn>RO-MF-000001463</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>H010201020101</emdnCode>
    <emdnDescription>POLYAMIDE MULTIFILAMENT WITH NEEDLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BX6005</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-08-02T22:39:36.848Z</lastUpdated>
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    <udiDi>05944756597115</udiDi>
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    <tradeName>BIONIL MULTIx</tradeName>
    <deviceName>BIONIL MULTIx</deviceName>
    <manufacturerName>BIOSINTEX SRL</manufacturerName>
    <manufacturerSrn>RO-MF-000001463</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>H010201020101</emdnCode>
    <emdnDescription>POLYAMIDE MULTIFILAMENT WITH NEEDLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BX6004</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-08-02T22:39:36.056Z</lastUpdated>
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    <tradeName>BIONIL MULTIx</tradeName>
    <deviceName>BIONIL MULTIx</deviceName>
    <manufacturerName>BIOSINTEX SRL</manufacturerName>
    <manufacturerSrn>RO-MF-000001463</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>H010201020101</emdnCode>
    <emdnDescription>POLYAMIDE MULTIFILAMENT WITH NEEDLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BX6003</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-08-02T22:39:35.272Z</lastUpdated>
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    <tradeName>BIONIL MULTIx</tradeName>
    <deviceName>BIONIL MULTIx</deviceName>
    <manufacturerName>BIOSINTEX SRL</manufacturerName>
    <manufacturerSrn>RO-MF-000001463</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>H010201020101</emdnCode>
    <emdnDescription>POLYAMIDE MULTIFILAMENT WITH NEEDLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BX6002</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-08-02T22:39:31.247Z</lastUpdated>
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    <udiDi>05944756597085</udiDi>
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    <tradeName>BIONIL MULTIx</tradeName>
    <deviceName>BIONIL MULTIx</deviceName>
    <manufacturerName>BIOSINTEX SRL</manufacturerName>
    <manufacturerSrn>RO-MF-000001463</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>H010201020101</emdnCode>
    <emdnDescription>POLYAMIDE MULTIFILAMENT WITH NEEDLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BX6001</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-08-02T22:39:30.577Z</lastUpdated>
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    <udiDi>05944756597078</udiDi>
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    <tradeName>BIONIL MULTIx</tradeName>
    <deviceName>BIONIL MULTIx</deviceName>
    <manufacturerName>BIOSINTEX SRL</manufacturerName>
    <manufacturerSrn>RO-MF-000001463</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>H010201020101</emdnCode>
    <emdnDescription>POLYAMIDE MULTIFILAMENT WITH NEEDLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BX6000</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-08-02T22:39:28.831Z</lastUpdated>
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    <basicUdiDi>B-05944756597061</basicUdiDi>
    <tradeName>BIONIL MULTIx</tradeName>
    <deviceName>BIONIL MULTIx</deviceName>
    <manufacturerName>BIOSINTEX SRL</manufacturerName>
    <manufacturerSrn>RO-MF-000001463</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>H010201020101</emdnCode>
    <emdnDescription>POLYAMIDE MULTIFILAMENT WITH NEEDLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BX699</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-08-02T22:39:28.026Z</lastUpdated>
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    <basicUdiDi>B-05944756597054</basicUdiDi>
    <tradeName>BIONIL MULTIx</tradeName>
    <deviceName>BIONIL MULTIx</deviceName>
    <manufacturerName>BIOSINTEX SRL</manufacturerName>
    <manufacturerSrn>RO-MF-000001463</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>H010201020101</emdnCode>
    <emdnDescription>POLYAMIDE MULTIFILAMENT WITH NEEDLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BX698</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-08-02T22:39:24.045Z</lastUpdated>
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    <basicUdiDi>B-06941173308699</basicUdiDi>
    <tradeName>06941173308699</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Jiangsu BANA Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025963</manufacturerSrn>
    <authorisedRepresentativeName>Caretechion GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005946</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>H020399</emdnCode>
    <emdnDescription>STAPLERS, VIDEOSURGERY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LW-110</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-02T22:39:23.246Z</lastUpdated>
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    <tradeName>BIONIL MULTIx</tradeName>
    <deviceName>BIONIL MULTIx</deviceName>
    <manufacturerName>BIOSINTEX SRL</manufacturerName>
    <manufacturerSrn>RO-MF-000001463</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>H010201020101</emdnCode>
    <emdnDescription>POLYAMIDE MULTIFILAMENT WITH NEEDLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BX697</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-08-02T22:39:23.220Z</lastUpdated>
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    <deviceName></deviceName>
    <manufacturerName>Jiangsu BANA Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025963</manufacturerSrn>
    <authorisedRepresentativeName>Caretechion GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005946</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>H010201010502</emdnCode>
    <emdnDescription>POLYTETRAFLUOROETHYLENE (PTFE)  MONOFILAMENT WITHOUT NEEDLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TZ-300</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-02T22:39:23.003Z</lastUpdated>
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    <manufacturerSrn>RO-MF-000001463</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <legislation>MDD</legislation>
    <emdnCode>H010201020101</emdnCode>
    <emdnDescription>POLYAMIDE MULTIFILAMENT WITH NEEDLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BX696</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-08-02T22:39:22.418Z</lastUpdated>
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    <tradeName>BIONIL MULTIx</tradeName>
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    <manufacturerName>BIOSINTEX SRL</manufacturerName>
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    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <legislation>MDD</legislation>
    <emdnCode>H010201020101</emdnCode>
    <emdnDescription>POLYAMIDE MULTIFILAMENT WITH NEEDLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BX695</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-08-02T22:39:21.622Z</lastUpdated>
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    <basicUdiDi>B-06941173335541</basicUdiDi>
    <tradeName>Disposable Clip Appliers</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Jiangsu BANA Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025963</manufacturerSrn>
    <authorisedRepresentativeName>Caretechion GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005946</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>H03020101</emdnCode>
    <emdnDescription>SINGLE-USE MULTIPLE CLIP APPLIERS FOR VIDEOSURGERY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TQ5</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-08-02T22:39:21.340Z</lastUpdated>
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    <deviceName></deviceName>
    <manufacturerName>Jiangsu BANA Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025963</manufacturerSrn>
    <authorisedRepresentativeName>Caretechion GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005946</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>H02010101</emdnCode>
    <emdnDescription>SKIN STAPLERS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NBWA32</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-02T22:39:20.998Z</lastUpdated>
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