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<eudamedExport entity="devices">
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    <tradeName>Biokey Anchorage screw</tradeName>
    <deviceName>Non Sterile Orthodontic Anchorage Screw</deviceName>
    <manufacturerName>BOMEI Co.,Ltd</manufacturerName>
    <manufacturerSrn>TW-MF-000013725</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q010499</emdnCode>
    <emdnDescription>ORTHODONTIC DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FH-2139-4</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T05:03:31.403Z</lastUpdated>
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    <udiDi>04719873183661</udiDi>
    <basicUdiDi>B-04719873183661</basicUdiDi>
    <tradeName>Biokey Anchorage screw</tradeName>
    <deviceName>Non Sterile Orthodontic Anchorage Screw</deviceName>
    <manufacturerName>BOMEI Co.,Ltd</manufacturerName>
    <manufacturerSrn>TW-MF-000013725</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q010499</emdnCode>
    <emdnDescription>ORTHODONTIC DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CH-2135-2</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T05:03:30.579Z</lastUpdated>
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  <row>
    <udiDi>04719873183241</udiDi>
    <basicUdiDi>B-04719873183241</basicUdiDi>
    <tradeName>Biokey Anchorage screw</tradeName>
    <deviceName>Non Sterile Orthodontic Anchorage Screw</deviceName>
    <manufacturerName>BOMEI Co.,Ltd</manufacturerName>
    <manufacturerSrn>TW-MF-000013725</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q010499</emdnCode>
    <emdnDescription>ORTHODONTIC DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BM-2127-4</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T05:03:29.778Z</lastUpdated>
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    <udiDi>04719873182831</udiDi>
    <basicUdiDi>B-04719873182831</basicUdiDi>
    <tradeName>Biokey Anchorage screw</tradeName>
    <deviceName>Non Sterile Orthodontic Anchorage Screw</deviceName>
    <manufacturerName>BOMEI Co.,Ltd</manufacturerName>
    <manufacturerSrn>TW-MF-000013725</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q010499</emdnCode>
    <emdnDescription>ORTHODONTIC DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BM-2103-0</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T05:03:25.780Z</lastUpdated>
  </row>
  <row>
    <udiDi>04719873182428</udiDi>
    <basicUdiDi>B-04719873182428</basicUdiDi>
    <tradeName>Biokey Anchorage screw</tradeName>
    <deviceName>Non Sterile Orthodontic Anchorage Screw</deviceName>
    <manufacturerName>BOMEI Co.,Ltd</manufacturerName>
    <manufacturerSrn>TW-MF-000013725</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q010499</emdnCode>
    <emdnDescription>ORTHODONTIC DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AT-2127-2</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T05:03:24.980Z</lastUpdated>
  </row>
  <row>
    <udiDi>04719873180950</udiDi>
    <basicUdiDi>B-04719873180950</basicUdiDi>
    <tradeName>Biokey Anchorage screw</tradeName>
    <deviceName>Non Sterile Orthodontic Anchorage Screw</deviceName>
    <manufacturerName>BOMEI Co.,Ltd</manufacturerName>
    <manufacturerSrn>TW-MF-000013725</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q010499</emdnCode>
    <emdnDescription>ORTHODONTIC DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AT-2115-0</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T05:03:23.391Z</lastUpdated>
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  <row>
    <udiDi>06009526124355</udiDi>
    <basicUdiDi>6009526100007GMTF02RB</basicUdiDi>
    <tradeName>FSP795-110000 1500ml autoclavable polysuphone collection jar, compete with cap assembly and overflow safety valve</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Gabler Medical (Pty) Ltd</manufacturerName>
    <manufacturerSrn>ZA-MF-000046864</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>DRAINAGE SYSTEMS WITH ADJUSTABLE SUCTION AND COLLECTION CHAMBER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FSP795-110000</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-06T03:18:18.575Z</lastUpdated>
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  <row>
    <udiDi>06009526124362</udiDi>
    <basicUdiDi>6009526100007GMTF02RB</basicUdiDi>
    <tradeName>FSP795-120000 2000ml autoclavable polysuphone collection jar, compete with cap assembly and overflow safety valve</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Gabler Medical (Pty) Ltd</manufacturerName>
    <manufacturerSrn>ZA-MF-000046864</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>DRAINAGE SYSTEMS WITH ADJUSTABLE SUCTION AND COLLECTION CHAMBER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FSP795-120000</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-06T03:18:18.535Z</lastUpdated>
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  <row>
    <udiDi>06009526124379</udiDi>
    <basicUdiDi>6009526100007GMTF02RB</basicUdiDi>
    <tradeName>FSP796-110000 1500ml autoclavable polysuphone collection jar, compete with cap assembly, for use with suction jars connected in series (no overflow valve)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Gabler Medical (Pty) Ltd</manufacturerName>
    <manufacturerSrn>ZA-MF-000046864</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>DRAINAGE SYSTEMS WITH ADJUSTABLE SUCTION AND COLLECTION CHAMBER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FSP796-110000</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-06T03:18:18.504Z</lastUpdated>
  </row>
  <row>
    <udiDi>06009526124386</udiDi>
    <basicUdiDi>6009526100007GMTF02RB</basicUdiDi>
    <tradeName>FSP796-120000 2000ml autoclavable polysuphone collection jar, compete with cap assembly, for use with suction jars connected in series (no overflow valve)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Gabler Medical (Pty) Ltd</manufacturerName>
    <manufacturerSrn>ZA-MF-000046864</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>DRAINAGE SYSTEMS WITH ADJUSTABLE SUCTION AND COLLECTION CHAMBER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FSP796-120000</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-06T03:18:18.462Z</lastUpdated>
  </row>
  <row>
    <udiDi>06009526128162</udiDi>
    <basicUdiDi>6009526100007GMTF02RB</basicUdiDi>
    <tradeName>FSR425-311215 High vacuum suction controller mounted on a rail clamp</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Gabler Medical (Pty) Ltd</manufacturerName>
    <manufacturerSrn>ZA-MF-000046864</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>DRAINAGE SYSTEMS WITH ADJUSTABLE SUCTION AND COLLECTION CHAMBER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FSR425-311215</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-06T03:18:18.438Z</lastUpdated>
  </row>
  <row>
    <udiDi>06009526128179</udiDi>
    <basicUdiDi>6009526100007GMTF02RB</basicUdiDi>
    <tradeName>FSR445-311215 Low vacuum suction controller mounted on a rail clamp</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Gabler Medical (Pty) Ltd</manufacturerName>
    <manufacturerSrn>ZA-MF-000046864</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>DRAINAGE SYSTEMS WITH ADJUSTABLE SUCTION AND COLLECTION CHAMBER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FSR445-311215</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-06T03:18:18.415Z</lastUpdated>
  </row>
  <row>
    <udiDi>06009526128186</udiDi>
    <basicUdiDi>6009526100007GMTF02RB</basicUdiDi>
    <tradeName>FSR465-311215 Thoracic suction controller mounted on a rail clamp</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Gabler Medical (Pty) Ltd</manufacturerName>
    <manufacturerSrn>ZA-MF-000046864</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>DRAINAGE SYSTEMS WITH ADJUSTABLE SUCTION AND COLLECTION CHAMBER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FSR465-311215</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-06T03:18:18.357Z</lastUpdated>
  </row>
  <row>
    <udiDi>06009526128193</udiDi>
    <basicUdiDi>6009526100007GMTF02RB</basicUdiDi>
    <tradeName>FSR425-311515 High vacuum suction controller mounted on a direct BS probe</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Gabler Medical (Pty) Ltd</manufacturerName>
    <manufacturerSrn>ZA-MF-000046864</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>DRAINAGE SYSTEMS WITH ADJUSTABLE SUCTION AND COLLECTION CHAMBER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FSP795-110000</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-06T03:18:18.311Z</lastUpdated>
  </row>
  <row>
    <udiDi>06009526128209</udiDi>
    <basicUdiDi>6009526100007GMTF02RB</basicUdiDi>
    <tradeName>FSR445-311515 Low vacuum suction controller mounted on a direct BS probe</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Gabler Medical (Pty) Ltd</manufacturerName>
    <manufacturerSrn>ZA-MF-000046864</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>DRAINAGE SYSTEMS WITH ADJUSTABLE SUCTION AND COLLECTION CHAMBER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FSR445-311515</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-06T03:18:18.287Z</lastUpdated>
  </row>
  <row>
    <udiDi>06009526128216</udiDi>
    <basicUdiDi>6009526100007GMTF02RB</basicUdiDi>
    <tradeName>FSR465-311515 Thoracic suction controller mounted on a direct BS probe</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Gabler Medical (Pty) Ltd</manufacturerName>
    <manufacturerSrn>ZA-MF-000046864</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>DRAINAGE SYSTEMS WITH ADJUSTABLE SUCTION AND COLLECTION CHAMBER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FSR465-311515</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-06T03:18:18.265Z</lastUpdated>
  </row>
  <row>
    <udiDi>06009526131971</udiDi>
    <basicUdiDi>6009526100007GMTF04RF</basicUdiDi>
    <tradeName>FRB202 	Universal Clamp with 2 Tapped Holes</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Gabler Medical (Pty) Ltd</manufacturerName>
    <manufacturerSrn>ZA-MF-000046864</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>MEDICAL SUPPORT EQUIPMENT - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FRB202</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-06T03:18:18.229Z</lastUpdated>
  </row>
  <row>
    <udiDi>06009526131988</udiDi>
    <basicUdiDi>6009526100007GMTF04RF</basicUdiDi>
    <tradeName>FRB203 	Universal Clamp with 2 Clearance Holes</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Gabler Medical (Pty) Ltd</manufacturerName>
    <manufacturerSrn>ZA-MF-000046864</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>MEDICAL SUPPORT EQUIPMENT - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FRB203</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-06T03:18:18.203Z</lastUpdated>
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  <row>
    <udiDi>06009526131995</udiDi>
    <basicUdiDi>6009526100007GMTF04RF</basicUdiDi>
    <tradeName>FRB204 	Male Threaded Wedge - 3 Holes</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Gabler Medical (Pty) Ltd</manufacturerName>
    <manufacturerSrn>ZA-MF-000046864</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>MEDICAL SUPPORT EQUIPMENT - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FRB204</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-06T03:18:18.153Z</lastUpdated>
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  <row>
    <udiDi>06009526132008</udiDi>
    <basicUdiDi>6009526100007GMTF04RF</basicUdiDi>
    <tradeName>FRB205 	Female Wedge</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Gabler Medical (Pty) Ltd</manufacturerName>
    <manufacturerSrn>ZA-MF-000046864</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>MEDICAL SUPPORT EQUIPMENT - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FRB205</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-06T03:18:18.112Z</lastUpdated>
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