<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>00840200403856</udiDi>
    <basicUdiDi>B-00840200403856</basicUdiDi>
    <tradeName>FlareHawk Interbody Fusion System</tradeName>
    <deviceName>Dilator 2, FH7 Endo</deviceName>
    <manufacturerName>Integrity Implants Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000009805</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>L0707020101</emdnCode>
    <emdnDescription>VALVE DILATORS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CMP-01984</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-05T03:18:34.863Z</lastUpdated>
  </row>
  <row>
    <udiDi>00840200403849</udiDi>
    <basicUdiDi>B-00840200403849</basicUdiDi>
    <tradeName>FlareHawk Interbody Fusion System</tradeName>
    <deviceName>Tall Dilator, FH7 Endo</deviceName>
    <manufacturerName>Integrity Implants Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000009805</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>L0707020101</emdnCode>
    <emdnDescription>VALVE DILATORS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CMP-01983</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-05T03:18:34.056Z</lastUpdated>
  </row>
  <row>
    <udiDi>00840200403115</udiDi>
    <basicUdiDi>B-00840200403115</basicUdiDi>
    <tradeName>FlareHawk Interbody Fusion System</tradeName>
    <deviceName>Removal Dilator 2, Short, FH7</deviceName>
    <manufacturerName>Integrity Implants Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000009805</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>L0707020101</emdnCode>
    <emdnDescription>VALVE DILATORS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CMP-01513</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-05T03:18:26.053Z</lastUpdated>
  </row>
  <row>
    <udiDi>00840200403108</udiDi>
    <basicUdiDi>B-00840200403108</basicUdiDi>
    <tradeName>FlareHawk Interbody Fusion System</tradeName>
    <deviceName>Removal Dilator 1, FH7</deviceName>
    <manufacturerName>Integrity Implants Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000009805</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>L0707020101</emdnCode>
    <emdnDescription>VALVE DILATORS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CMP-01512</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-05T03:18:25.247Z</lastUpdated>
  </row>
  <row>
    <udiDi>00840200403085</udiDi>
    <basicUdiDi>B-00840200403085</basicUdiDi>
    <tradeName>FlareHawk Interbody Fusion System</tradeName>
    <deviceName>1 Step Dilator, Short, FH7 MIS</deviceName>
    <manufacturerName>Integrity Implants Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000009805</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>L0707020101</emdnCode>
    <emdnDescription>VALVE DILATORS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CMP-01738</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-05T03:18:21.250Z</lastUpdated>
  </row>
</eudamedExport>