<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>06921814200094</udiDi>
    <basicUdiDi>B-06921814200094</basicUdiDi>
    <tradeName>06921814200094</tradeName>
    <deviceName>VA Locking Screw</deviceName>
    <manufacturerName>Tianjin Zhengtian Medical Instrument Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000020115</manufacturerSrn>
    <authorisedRepresentativeName>Inion Oy</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FI-AR-000046224</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P09120601</emdnCode>
    <emdnDescription>CORTICAL SCREWS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TC50102424</reference>
    <placedOnMarketCountry>Portugal</placedOnMarketCountry>
    <lastUpdated>2026-08-03T02:00:46.962Z</lastUpdated>
  </row>
  <row>
    <udiDi>06921814200087</udiDi>
    <basicUdiDi>B-06921814200087</basicUdiDi>
    <tradeName>06921814200087</tradeName>
    <deviceName>VA Locking Screw</deviceName>
    <manufacturerName>Tianjin Zhengtian Medical Instrument Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000020115</manufacturerSrn>
    <authorisedRepresentativeName>Inion Oy</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FI-AR-000046224</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P09120601</emdnCode>
    <emdnDescription>CORTICAL SCREWS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TC50102422</reference>
    <placedOnMarketCountry>Portugal</placedOnMarketCountry>
    <lastUpdated>2026-08-03T02:00:42.961Z</lastUpdated>
  </row>
  <row>
    <udiDi>06921814200070</udiDi>
    <basicUdiDi>B-06921814200070</basicUdiDi>
    <tradeName>06921814200070</tradeName>
    <deviceName>VA Locking Screw</deviceName>
    <manufacturerName>Tianjin Zhengtian Medical Instrument Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000020115</manufacturerSrn>
    <authorisedRepresentativeName>Inion Oy</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FI-AR-000046224</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P09120601</emdnCode>
    <emdnDescription>CORTICAL SCREWS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TC50102420</reference>
    <placedOnMarketCountry>Portugal</placedOnMarketCountry>
    <lastUpdated>2026-08-03T02:00:42.163Z</lastUpdated>
  </row>
  <row>
    <udiDi>06921814200063</udiDi>
    <basicUdiDi>B-06921814200063</basicUdiDi>
    <tradeName>06921814200063</tradeName>
    <deviceName>VA Locking Screw</deviceName>
    <manufacturerName>Tianjin Zhengtian Medical Instrument Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000020115</manufacturerSrn>
    <authorisedRepresentativeName>Inion Oy</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FI-AR-000046224</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P09120601</emdnCode>
    <emdnDescription>CORTICAL SCREWS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TC50102418</reference>
    <placedOnMarketCountry>Portugal</placedOnMarketCountry>
    <lastUpdated>2026-08-03T02:00:41.347Z</lastUpdated>
  </row>
  <row>
    <udiDi>06921814200056</udiDi>
    <basicUdiDi>B-06921814200056</basicUdiDi>
    <tradeName>06921814200056</tradeName>
    <deviceName>VA Locking Screw</deviceName>
    <manufacturerName>Tianjin Zhengtian Medical Instrument Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000020115</manufacturerSrn>
    <authorisedRepresentativeName>Inion Oy</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FI-AR-000046224</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P09120601</emdnCode>
    <emdnDescription>CORTICAL SCREWS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TC50102416</reference>
    <placedOnMarketCountry>Portugal</placedOnMarketCountry>
    <lastUpdated>2026-08-03T02:00:40.558Z</lastUpdated>
  </row>
  <row>
    <udiDi>06921814200049</udiDi>
    <basicUdiDi>B-06921814200049</basicUdiDi>
    <tradeName>06921814200049</tradeName>
    <deviceName>VA Locking Screw</deviceName>
    <manufacturerName>Tianjin Zhengtian Medical Instrument Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000020115</manufacturerSrn>
    <authorisedRepresentativeName>Inion Oy</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FI-AR-000046224</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P09120601</emdnCode>
    <emdnDescription>CORTICAL SCREWS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TC50102414</reference>
    <placedOnMarketCountry>Portugal</placedOnMarketCountry>
    <lastUpdated>2026-08-03T02:00:36.549Z</lastUpdated>
  </row>
  <row>
    <udiDi>06921814200032</udiDi>
    <basicUdiDi>B-06921814200032</basicUdiDi>
    <tradeName>06921814200032</tradeName>
    <deviceName>VA Locking Screw</deviceName>
    <manufacturerName>Tianjin Zhengtian Medical Instrument Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000020115</manufacturerSrn>
    <authorisedRepresentativeName>Inion Oy</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FI-AR-000046224</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P09120601</emdnCode>
    <emdnDescription>CORTICAL SCREWS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TC50102412</reference>
    <placedOnMarketCountry>Portugal</placedOnMarketCountry>
    <lastUpdated>2026-08-03T02:00:35.783Z</lastUpdated>
  </row>
  <row>
    <udiDi>06921814200025</udiDi>
    <basicUdiDi>B-06921814200025</basicUdiDi>
    <tradeName>06921814200025</tradeName>
    <deviceName>VA Locking Screw</deviceName>
    <manufacturerName>Tianjin Zhengtian Medical Instrument Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000020115</manufacturerSrn>
    <authorisedRepresentativeName>Inion Oy</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FI-AR-000046224</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P09120601</emdnCode>
    <emdnDescription>CORTICAL SCREWS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TC50102410</reference>
    <placedOnMarketCountry>Portugal</placedOnMarketCountry>
    <lastUpdated>2026-08-03T02:00:34.951Z</lastUpdated>
  </row>
  <row>
    <udiDi>06921814200018</udiDi>
    <basicUdiDi>B-06921814200018</basicUdiDi>
    <tradeName>06921814200018</tradeName>
    <deviceName>VA Locking Screw</deviceName>
    <manufacturerName>Tianjin Zhengtian Medical Instrument Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000020115</manufacturerSrn>
    <authorisedRepresentativeName>Inion Oy</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FI-AR-000046224</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P09120601</emdnCode>
    <emdnDescription>CORTICAL SCREWS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TC50102408</reference>
    <placedOnMarketCountry>Portugal</placedOnMarketCountry>
    <lastUpdated>2026-08-03T02:00:34.153Z</lastUpdated>
  </row>
  <row>
    <udiDi>06902139293909</udiDi>
    <basicUdiDi>B-06902139293909</basicUdiDi>
    <tradeName>06902139293909</tradeName>
    <deviceName>PEEK Interference Screw</deviceName>
    <manufacturerName>Double Medical Technology Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000009048</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P09120699</emdnCode>
    <emdnDescription>BONE FIXATION SCREWS, TENDON AND LIGAMENT SYNTHESIS SCREWS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>152150928S</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-08-03T01:28:38.804Z</lastUpdated>
  </row>
  <row>
    <udiDi>06902139293893</udiDi>
    <basicUdiDi>B-06902139293893</basicUdiDi>
    <tradeName>06902139293893</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Double Medical Technology Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000009048</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P09120699</emdnCode>
    <emdnDescription>BONE FIXATION SCREWS, TENDON AND LIGAMENT SYNTHESIS SCREWS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>153570923S</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-08-03T01:28:38.018Z</lastUpdated>
  </row>
  <row>
    <udiDi>06902139292865</udiDi>
    <basicUdiDi>B-06902139292865</basicUdiDi>
    <tradeName>06902139292865</tradeName>
    <deviceName>PEEK Interference Screw</deviceName>
    <manufacturerName>Double Medical Technology Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000009048</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P09120699</emdnCode>
    <emdnDescription>BONE FIXATION SCREWS, TENDON AND LIGAMENT SYNTHESIS SCREWS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>153570823S</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-08-03T01:28:34.006Z</lastUpdated>
  </row>
  <row>
    <udiDi>06902139292858</udiDi>
    <basicUdiDi>B-06902139292858</basicUdiDi>
    <tradeName>06902139292858</tradeName>
    <deviceName>PEEK Interference Screw</deviceName>
    <manufacturerName>Double Medical Technology Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000009048</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P09120699</emdnCode>
    <emdnDescription>BONE FIXATION SCREWS, TENDON AND LIGAMENT SYNTHESIS SCREWS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>152150728S</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-08-03T01:28:33.232Z</lastUpdated>
  </row>
  <row>
    <udiDi>06902139292841</udiDi>
    <basicUdiDi>B-06902139292841</basicUdiDi>
    <tradeName>06902139292841</tradeName>
    <deviceName>PEEK Interference Screw</deviceName>
    <manufacturerName>Double Medical Technology Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000009048</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P09120699</emdnCode>
    <emdnDescription>BONE FIXATION SCREWS, TENDON AND LIGAMENT SYNTHESIS SCREWS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>153570723S</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-08-03T01:28:32.432Z</lastUpdated>
  </row>
  <row>
    <udiDi>06902139292834</udiDi>
    <basicUdiDi>B-06902139292834</basicUdiDi>
    <tradeName>06902139292834</tradeName>
    <deviceName>PEEK Interference Screw</deviceName>
    <manufacturerName>Double Medical Technology Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000009048</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P09120699</emdnCode>
    <emdnDescription>BONE FIXATION SCREWS, TENDON AND LIGAMENT SYNTHESIS SCREWS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>152150623S</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-08-03T01:28:31.636Z</lastUpdated>
  </row>
  <row>
    <udiDi>06438408012402</udiDi>
    <basicUdiDi>B-06438408012402</basicUdiDi>
    <tradeName>Inion OTPS™ Pin</tradeName>
    <deviceName>Inion OTPS Pin</deviceName>
    <manufacturerName>Inion Oy</manufacturerName>
    <manufacturerSrn>FI-MF-000000646</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P09120606</emdnCode>
    <emdnDescription>OSTEOSYNTHESIS DEVICES, BIODEGRADABLE SCREWS AND BARS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PCK-7002</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-08-03T01:24:37.509Z</lastUpdated>
  </row>
  <row>
    <udiDi>06438408012396</udiDi>
    <basicUdiDi>B-06438408012396</basicUdiDi>
    <tradeName>Inion OTPS™ Pin</tradeName>
    <deviceName>Inion OTPS Pin</deviceName>
    <manufacturerName>Inion Oy</manufacturerName>
    <manufacturerSrn>FI-MF-000000646</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P09120606</emdnCode>
    <emdnDescription>OSTEOSYNTHESIS DEVICES, BIODEGRADABLE SCREWS AND BARS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PCK-7001</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-08-03T01:24:35.815Z</lastUpdated>
  </row>
  <row>
    <udiDi>06438408012389</udiDi>
    <basicUdiDi>B-06438408012389</basicUdiDi>
    <tradeName>Inion FreedomPin™</tradeName>
    <deviceName>Inion FreedomPin</deviceName>
    <manufacturerName>Inion Oy</manufacturerName>
    <manufacturerSrn>FI-MF-000000646</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P09120606</emdnCode>
    <emdnDescription>OSTEOSYNTHESIS DEVICES, BIODEGRADABLE SCREWS AND BARS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OPK-20K3</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-08-03T01:24:33.722Z</lastUpdated>
  </row>
  <row>
    <udiDi>06438408012372</udiDi>
    <basicUdiDi>B-06438408012372</basicUdiDi>
    <tradeName>Inion FreedomPin™</tradeName>
    <deviceName>Inion FreedomPin</deviceName>
    <manufacturerName>Inion Oy</manufacturerName>
    <manufacturerSrn>FI-MF-000000646</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P09120606</emdnCode>
    <emdnDescription>OSTEOSYNTHESIS DEVICES, BIODEGRADABLE SCREWS AND BARS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OPK-20K2</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-08-03T01:24:31.800Z</lastUpdated>
  </row>
  <row>
    <udiDi>06438408012365</udiDi>
    <basicUdiDi>B-06438408012365</basicUdiDi>
    <tradeName>Inion FreedomPin™</tradeName>
    <deviceName>Inion FreedomPin</deviceName>
    <manufacturerName>Inion Oy</manufacturerName>
    <manufacturerSrn>FI-MF-000000646</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P09120606</emdnCode>
    <emdnDescription>OSTEOSYNTHESIS DEVICES, BIODEGRADABLE SCREWS AND BARS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OPK-20K1</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-08-03T01:24:31.596Z</lastUpdated>
  </row>
</eudamedExport>