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<eudamedExport entity="devices">
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    <basicUdiDi>B-04260638513570</basicUdiDi>
    <tradeName>VentrEX® EVD-System</tradeName>
    <deviceName>VentrEX® EVD System</deviceName>
    <manufacturerName>Neuromedex GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005867</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>N010303</emdnCode>
    <emdnDescription>CEREBRAL FLUID EXTERNAL DRAINS AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>57-00121</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T14:31:29.008Z</lastUpdated>
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    <udiDi>03760124131246</udiDi>
    <basicUdiDi>B-03760124131246</basicUdiDi>
    <tradeName>SOPHY® SM8B KIT PREATTACHED / BO19-10</tradeName>
    <deviceName>SOPHY® SM8B KIT PREATTACHED / BO19-10</deviceName>
    <manufacturerName>SOPHYSA</manufacturerName>
    <manufacturerSrn>FR-MF-000002870</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>N01038099</emdnCode>
    <emdnDescription>INTRACRANIAL DRAINAGE DEVICES AND KITS - ACCESSORIES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SM8B-2010</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-16T11:33:31.720Z</lastUpdated>
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  <row>
    <udiDi>03760124131192</udiDi>
    <basicUdiDi>B-03760124131192</basicUdiDi>
    <tradeName>VALVE AJUSTABLE SOPHY® MINI/ 8 PRESS. 80-400</tradeName>
    <deviceName>SOPHY® MINI ADJUSTABLE VALVE/ 8 PRESS. 80-400</deviceName>
    <manufacturerName>SOPHYSA</manufacturerName>
    <manufacturerSrn>FR-MF-000002870</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>N01038002</emdnCode>
    <emdnDescription>INTRACRANIAL DRAINAGE DEVICE VALVES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SM8-400</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-16T11:33:27.727Z</lastUpdated>
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    <udiDi>03760124131185</udiDi>
    <basicUdiDi>B-03760124131185</basicUdiDi>
    <tradeName>VALVE AJUSTABLE SOPHY® MINI/ 8 PRESS. 50-300</tradeName>
    <deviceName>SOPHY® MINI ADJUSTABLE VALVE/ 8 PRESS. 50-30</deviceName>
    <manufacturerName>SOPHYSA</manufacturerName>
    <manufacturerSrn>FR-MF-000002870</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>N01038002</emdnCode>
    <emdnDescription>INTRACRANIAL DRAINAGE DEVICE VALVES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SM8-300</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-16T11:33:26.927Z</lastUpdated>
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  <row>
    <udiDi>03760124131239</udiDi>
    <basicUdiDi>B-03760124131239</basicUdiDi>
    <tradeName>VALVE AJUSTABLE SOPHY® SM8 / RESERVOIR TROU TREPAN</tradeName>
    <deviceName>SOPHY® SM8 ADJUSTABLE VALVE / BURR HOLE RESERVOIR</deviceName>
    <manufacturerName>SOPHYSA</manufacturerName>
    <manufacturerSrn>FR-MF-000002870</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>N01038099</emdnCode>
    <emdnDescription>INTRACRANIAL DRAINAGE DEVICES AND KITS - ACCESSORIES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SM8B</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T11:33:26.115Z</lastUpdated>
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  <row>
    <udiDi>03760124131208</udiDi>
    <basicUdiDi>B-03760124131208</basicUdiDi>
    <tradeName>KIT SOPHY® SM8-400 PRECONNECTE/ BO19-10</tradeName>
    <deviceName>8KIT SOPHY® SM8-400 PRECONNECTE/ BO19-10</deviceName>
    <manufacturerName>SOPHYSA</manufacturerName>
    <manufacturerSrn>FR-MF-000002870</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>N01038099</emdnCode>
    <emdnDescription>INTRACRANIAL DRAINAGE DEVICES AND KITS - ACCESSORIES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SM8-400-2010</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-16T11:33:25.412Z</lastUpdated>
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    <udiDi>03760124131178</udiDi>
    <basicUdiDi>B-03760124131178</basicUdiDi>
    <tradeName>KIT SOPHY® SM8 LOMBO-PERITONEAL PRECONNECTE</tradeName>
    <deviceName>LUMBO-PERITONEAL SOPHY® SM8 KIT PREATTACHED</deviceName>
    <manufacturerName>SOPHYSA</manufacturerName>
    <manufacturerSrn>FR-MF-000002870</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>N01038099</emdnCode>
    <emdnDescription>INTRACRANIAL DRAINAGE DEVICES AND KITS - ACCESSORIES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SM8-2040</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-16T11:33:08.451Z</lastUpdated>
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  <row>
    <udiDi>03760124130072</udiDi>
    <basicUdiDi>B-03760124130072</basicUdiDi>
    <tradeName>CATHETER VENTRICULAIRE DROIT GRADUE 1.3 x 2.2</tradeName>
    <deviceName>Graduated straight ventricular catheter 1.3 x 2.2</deviceName>
    <manufacturerName>SOPHYSA</manufacturerName>
    <manufacturerSrn>FR-MF-000002870</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>N01038099</emdnCode>
    <emdnDescription>INTRACRANIAL DRAINAGE DEVICES AND KITS - ACCESSORIES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BO19-20</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-16T11:33:07.653Z</lastUpdated>
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  <row>
    <udiDi>03760124130065</udiDi>
    <basicUdiDi>B-03760124130065</basicUdiDi>
    <tradeName>CATHETER VENTRICULAIRE DROIT STANDARD 1.3 x 2.5</tradeName>
    <deviceName>Standard straight ventricular catheter 1.3 x 2.5</deviceName>
    <manufacturerName>SOPHYSA</manufacturerName>
    <manufacturerSrn>FR-MF-000002870</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>N01038099</emdnCode>
    <emdnDescription>INTRACRANIAL DRAINAGE DEVICES AND KITS - ACCESSORIES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BO19-10</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-16T11:33:06.865Z</lastUpdated>
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  <row>
    <udiDi>03760124130041</udiDi>
    <basicUdiDi>B-03760124130041</basicUdiDi>
    <tradeName>CATH. VENTRICULAIRE DROIT PEDIATRIQUE 1.3 x 2.2</tradeName>
    <deviceName>Paediatric straight ventricular catheter 1.3 x 2.2</deviceName>
    <manufacturerName>SOPHYSA</manufacturerName>
    <manufacturerSrn>FR-MF-000002870</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>N01038099</emdnCode>
    <emdnDescription>INTRACRANIAL DRAINAGE DEVICES AND KITS - ACCESSORIES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BO15</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-16T11:33:06.053Z</lastUpdated>
  </row>
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    <udiDi>00868643000470</udiDi>
    <basicUdiDi>086864300047CZ</basicUdiDi>
    <tradeName>IRRAflow Drainage Collection System</tradeName>
    <deviceName>IRRAflow Drainage Collection System</deviceName>
    <manufacturerName>ClearPoint Neuro, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010239</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>N01038099</emdnCode>
    <emdnDescription>INTRACRANIAL DRAINAGE DEVICES AND KITS - ACCESSORIES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DCS 010</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-16T04:01:00.844Z</lastUpdated>
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    <udiDi>00868643000401</udiDi>
    <basicUdiDi>086864300040CK</basicUdiDi>
    <tradeName>IRRAflow Control Unit 4.0</tradeName>
    <deviceName>IRRAflow Control Unit 4.0</deviceName>
    <manufacturerName>IRRAS USA Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000011820</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>N010303</emdnCode>
    <emdnDescription>CEREBRAL FLUID EXTERNAL DRAINS AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ICCU 020</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-16T04:01:00.052Z</lastUpdated>
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  <row>
    <udiDi>D-8683955206325DX</udiDi>
    <basicUdiDi>B-8683955206325DX</basicUdiDi>
    <tradeName>DESU</tradeName>
    <deviceName>External nörolojik drenaj sistemi tutucu ve ölçüm cetveli</deviceName>
    <manufacturerName>DESU MEDİKAL ÜRÜNLER VE TIBBİ CİHAZLAR SANAYİ VE TİCARET ANONİM ŞİRKETİ</manufacturerName>
    <manufacturerSrn>TR-MF-000031476</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>N010301</emdnCode>
    <emdnDescription>VENTRICULAR-PERITONEAL SHUNTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ENDS-HL</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-12T14:27:09.756Z</lastUpdated>
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    <udiDi>D-8683955206288EJ</udiDi>
    <basicUdiDi>B-8683955206288EJ</basicUdiDi>
    <tradeName>DESU</tradeName>
    <deviceName>DEPUS Ayarlanabilir Şant , Antibiyotik Emdirilmiş Ventriküloperitonel kateter kiti ve Sağ Açılı Konnektör Antisifon Aparatı ile</deviceName>
    <manufacturerName>DESU MEDİKAL ÜRÜNLER VE TIBBİ CİHAZLAR SANAYİ VE TİCARET ANONİM ŞİRKETİ</manufacturerName>
    <manufacturerSrn>TR-MF-000031476</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>N010301</emdnCode>
    <emdnDescription>VENTRICULAR-PERITONEAL SHUNTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DP-A-VACK-RAC-ASD</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-12T14:27:09.206Z</lastUpdated>
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    <udiDi>D-8683955206097E9</udiDi>
    <basicUdiDi>B-8683955206097E9</basicUdiDi>
    <tradeName>DESU</tradeName>
    <deviceName>Eksternal Nörolojik Drenaj Sistemi – Antibiyotik Emdirilmiş 9F Kateterli</deviceName>
    <manufacturerName>DESU MEDİKAL ÜRÜNLER VE TIBBİ CİHAZLAR SANAYİ VE TİCARET ANONİM ŞİRKETİ</manufacturerName>
    <manufacturerSrn>TR-MF-000031476</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>N010303</emdnCode>
    <emdnDescription>CEREBRAL FLUID EXTERNAL DRAINS AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ENDS-AC9F-020</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-12T14:26:22.390Z</lastUpdated>
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    <udiDi>D-8683955206080DQ</udiDi>
    <basicUdiDi>B-8683955206080DQ</basicUdiDi>
    <tradeName>DESU</tradeName>
    <deviceName>Eksternal Nörolojik Drenaj Sistemi – Antibiyotik Emdirilmiş 8F Kateterli</deviceName>
    <manufacturerName>DESU MEDİKAL ÜRÜNLER VE TIBBİ CİHAZLAR SANAYİ VE TİCARET ANONİM ŞİRKETİ</manufacturerName>
    <manufacturerSrn>TR-MF-000031476</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>N010303</emdnCode>
    <emdnDescription>CEREBRAL FLUID EXTERNAL DRAINS AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ENDS-AC8F-020</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-12T14:26:21.605Z</lastUpdated>
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    <udiDi>D-8683955206073DT</udiDi>
    <basicUdiDi>B-8683955206073DT</basicUdiDi>
    <tradeName>DESU</tradeName>
    <deviceName>Eksternal Nörolojik Drenaj Sistemi – Antibiyotik Emdirilmiş Kateterli</deviceName>
    <manufacturerName>DESU MEDİKAL ÜRÜNLER VE TIBBİ CİHAZLAR SANAYİ VE TİCARET ANONİM ŞİRKETİ</manufacturerName>
    <manufacturerSrn>TR-MF-000031476</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>N010303</emdnCode>
    <emdnDescription>CEREBRAL FLUID EXTERNAL DRAINS AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ENDS-AC-022</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-12T14:26:17.584Z</lastUpdated>
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    <udiDi>D-8683955206066DW</udiDi>
    <basicUdiDi>B-8683955206066DW</basicUdiDi>
    <tradeName>DESU</tradeName>
    <deviceName>Eksternal Nörolojik Drenaj Sistemi – Antibiyotik Emdirilmiş Kateterli</deviceName>
    <manufacturerName>DESU MEDİKAL ÜRÜNLER VE TIBBİ CİHAZLAR SANAYİ VE TİCARET ANONİM ŞİRKETİ</manufacturerName>
    <manufacturerSrn>TR-MF-000031476</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>N010303</emdnCode>
    <emdnDescription>CEREBRAL FLUID EXTERNAL DRAINS AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ENDS-AC-021</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-12T14:26:16.791Z</lastUpdated>
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    <udiDi>D-8683955206042DG</udiDi>
    <basicUdiDi>B-8683955206042DG</basicUdiDi>
    <tradeName>DESU</tradeName>
    <deviceName>Eksternal Norolojik Drenaj Sistemi - 9F Kateterli</deviceName>
    <manufacturerName>DESU MEDİKAL ÜRÜNLER VE TIBBİ CİHAZLAR SANAYİ VE TİCARET ANONİM ŞİRKETİ</manufacturerName>
    <manufacturerSrn>TR-MF-000031476</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>N010303</emdnCode>
    <emdnDescription>CEREBRAL FLUID EXTERNAL DRAINS AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ENDS-C9F-020</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-12T14:26:15.996Z</lastUpdated>
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    <udiDi>D-8683955206059DZ</udiDi>
    <basicUdiDi>B-8683955206059DZ</basicUdiDi>
    <tradeName>DESU</tradeName>
    <deviceName>Eksternal Nörolojik Drenaj Sistemi – Antibiyotik Emdirilmiş Kateterli</deviceName>
    <manufacturerName>DESU MEDİKAL ÜRÜNLER VE TIBBİ CİHAZLAR SANAYİ VE TİCARET ANONİM ŞİRKETİ</manufacturerName>
    <manufacturerSrn>TR-MF-000031476</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>N010303</emdnCode>
    <emdnDescription>CEREBRAL FLUID EXTERNAL DRAINS AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ENDS-AC-020</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-12T14:26:15.185Z</lastUpdated>
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