<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>00818613020021</udiDi>
    <basicUdiDi>B-00818613020021</basicUdiDi>
    <tradeName>FlareHawk Interbody Fusion System</tradeName>
    <deviceName>11mm Shaver</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>L091202</emdnCode>
    <emdnDescription>ORTHOPAEDIC SURGERY FILES, REUSABLE</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>II-1-0322</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-04T19:19:46.092Z</lastUpdated>
  </row>
  <row>
    <udiDi>00818613020014</udiDi>
    <basicUdiDi>B-00818613020014</basicUdiDi>
    <tradeName>FlareHawk Interbody Fusion System</tradeName>
    <deviceName>10mm Shaver</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>L091202</emdnCode>
    <emdnDescription>ORTHOPAEDIC SURGERY FILES, REUSABLE</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>II-1-0321</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-04T19:19:45.291Z</lastUpdated>
  </row>
  <row>
    <udiDi>00818613020007</udiDi>
    <basicUdiDi>B-00818613020007</basicUdiDi>
    <tradeName>FlareHawk Interbody Fusion System</tradeName>
    <deviceName>9mm Shaver</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>L091202</emdnCode>
    <emdnDescription>ORTHOPAEDIC SURGERY FILES, REUSABLE</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>II-1-0320</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-04T19:19:39.692Z</lastUpdated>
  </row>
  <row>
    <udiDi>05908447158023</udiDi>
    <basicUdiDi>59084472NL035ME</basicUdiDi>
    <tradeName>05908447158023</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ChM spółka z ograniczoną odpowiedzialnością</manufacturerName>
    <manufacturerSrn>PL-MF-000002121</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>L091202</emdnCode>
    <emdnDescription>ORTHOPAEDIC SURGERY FILES, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>40.6210.000</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-04T18:29:18.827Z</lastUpdated>
  </row>
  <row>
    <udiDi>05908447158061</udiDi>
    <basicUdiDi>59084472NL054MJ</basicUdiDi>
    <tradeName>05908447158061</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ChM spółka z ograniczoną odpowiedzialnością</manufacturerName>
    <manufacturerSrn>PL-MF-000002121</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>L091201</emdnCode>
    <emdnDescription>ORTHOPAEDIC SURGERY RASPS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>40.6212.000</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-04T18:29:18.778Z</lastUpdated>
  </row>
  <row>
    <udiDi>05908447158085</udiDi>
    <basicUdiDi>59084472NL054MJ</basicUdiDi>
    <tradeName>05908447158085</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ChM spółka z ograniczoną odpowiedzialnością</manufacturerName>
    <manufacturerSrn>PL-MF-000002121</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>L091201</emdnCode>
    <emdnDescription>ORTHOPAEDIC SURGERY RASPS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>40.6213.000</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-04T18:29:18.753Z</lastUpdated>
  </row>
  <row>
    <udiDi>05908447158108</udiDi>
    <basicUdiDi>59084472NL054MJ</basicUdiDi>
    <tradeName>05908447158108</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ChM spółka z ograniczoną odpowiedzialnością</manufacturerName>
    <manufacturerSrn>PL-MF-000002121</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>L091201</emdnCode>
    <emdnDescription>ORTHOPAEDIC SURGERY RASPS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>40.6214.000</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-04T18:29:18.732Z</lastUpdated>
  </row>
  <row>
    <udiDi>05908447160248</udiDi>
    <basicUdiDi>59084472NL165MU</basicUdiDi>
    <tradeName>05908447160248</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ChM spółka z ograniczoną odpowiedzialnością</manufacturerName>
    <manufacturerSrn>PL-MF-000002121</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>L091201</emdnCode>
    <emdnDescription>ORTHOPAEDIC SURGERY RASPS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>30.4211.000</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-04T18:29:16.991Z</lastUpdated>
  </row>
  <row>
    <udiDi>05908447209640</udiDi>
    <basicUdiDi>59084472NL165MU</basicUdiDi>
    <tradeName>05908447209640</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ChM spółka z ograniczoną odpowiedzialnością</manufacturerName>
    <manufacturerSrn>PL-MF-000002121</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>L091201</emdnCode>
    <emdnDescription>ORTHOPAEDIC SURGERY RASPS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>30.4200.000</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-04T18:27:59.894Z</lastUpdated>
  </row>
  <row>
    <udiDi>05908447209664</udiDi>
    <basicUdiDi>59084472NL165MU</basicUdiDi>
    <tradeName>05908447209664</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ChM spółka z ograniczoną odpowiedzialnością</manufacturerName>
    <manufacturerSrn>PL-MF-000002121</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>L091201</emdnCode>
    <emdnDescription>ORTHOPAEDIC SURGERY RASPS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>30.4202.000</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-04T18:27:59.879Z</lastUpdated>
  </row>
  <row>
    <udiDi>05908447209688</udiDi>
    <basicUdiDi>59084472NL165MU</basicUdiDi>
    <tradeName>05908447209688</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ChM spółka z ograniczoną odpowiedzialnością</manufacturerName>
    <manufacturerSrn>PL-MF-000002121</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>L091201</emdnCode>
    <emdnDescription>ORTHOPAEDIC SURGERY RASPS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>30.4203.000</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-04T18:27:59.868Z</lastUpdated>
  </row>
  <row>
    <udiDi>05908447209701</udiDi>
    <basicUdiDi>59084472NL165MU</basicUdiDi>
    <tradeName>05908447209701</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ChM spółka z ograniczoną odpowiedzialnością</manufacturerName>
    <manufacturerSrn>PL-MF-000002121</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>L091201</emdnCode>
    <emdnDescription>ORTHOPAEDIC SURGERY RASPS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>30.4204.000</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-04T18:27:59.856Z</lastUpdated>
  </row>
  <row>
    <udiDi>05908447209725</udiDi>
    <basicUdiDi>59084472NL165MU</basicUdiDi>
    <tradeName>05908447209725</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ChM spółka z ograniczoną odpowiedzialnością</manufacturerName>
    <manufacturerSrn>PL-MF-000002121</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>L091201</emdnCode>
    <emdnDescription>ORTHOPAEDIC SURGERY RASPS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>30.4205.000</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-04T18:27:59.841Z</lastUpdated>
  </row>
  <row>
    <udiDi>05908447209749</udiDi>
    <basicUdiDi>59084472NL165MU</basicUdiDi>
    <tradeName>05908447209749</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ChM spółka z ograniczoną odpowiedzialnością</manufacturerName>
    <manufacturerSrn>PL-MF-000002121</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>L091201</emdnCode>
    <emdnDescription>ORTHOPAEDIC SURGERY RASPS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>30.4206.000</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-04T18:27:59.825Z</lastUpdated>
  </row>
  <row>
    <udiDi>05908447213609</udiDi>
    <basicUdiDi>59084472NL165MU</basicUdiDi>
    <tradeName>05908447213609</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ChM spółka z ograniczoną odpowiedzialnością</manufacturerName>
    <manufacturerSrn>PL-MF-000002121</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>L091201</emdnCode>
    <emdnDescription>ORTHOPAEDIC SURGERY RASPS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>30.4207.000</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-04T18:27:58.780Z</lastUpdated>
  </row>
  <row>
    <udiDi>05908447213623</udiDi>
    <basicUdiDi>59084472NL165MU</basicUdiDi>
    <tradeName>05908447213623</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ChM spółka z ograniczoną odpowiedzialnością</manufacturerName>
    <manufacturerSrn>PL-MF-000002121</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>L091201</emdnCode>
    <emdnDescription>ORTHOPAEDIC SURGERY RASPS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>30.4208.000</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-04T18:27:58.764Z</lastUpdated>
  </row>
  <row>
    <udiDi>05908447213647</udiDi>
    <basicUdiDi>59084472NL165MU</basicUdiDi>
    <tradeName>05908447213647</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ChM spółka z ograniczoną odpowiedzialnością</manufacturerName>
    <manufacturerSrn>PL-MF-000002121</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>L091201</emdnCode>
    <emdnDescription>ORTHOPAEDIC SURGERY RASPS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>30.4210.000</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-04T18:27:58.755Z</lastUpdated>
  </row>
  <row>
    <udiDi>05908447213661</udiDi>
    <basicUdiDi>59084472NL165MU</basicUdiDi>
    <tradeName>05908447213661</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ChM spółka z ograniczoną odpowiedzialnością</manufacturerName>
    <manufacturerSrn>PL-MF-000002121</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>L091201</emdnCode>
    <emdnDescription>ORTHOPAEDIC SURGERY RASPS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>30.4213.000</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-04T18:27:58.742Z</lastUpdated>
  </row>
  <row>
    <udiDi>05908447213685</udiDi>
    <basicUdiDi>59084472NL165MU</basicUdiDi>
    <tradeName>05908447213685</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ChM spółka z ograniczoną odpowiedzialnością</manufacturerName>
    <manufacturerSrn>PL-MF-000002121</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>L091201</emdnCode>
    <emdnDescription>ORTHOPAEDIC SURGERY RASPS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>30.4214.000</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-04T18:27:58.726Z</lastUpdated>
  </row>
  <row>
    <udiDi>05908447232402</udiDi>
    <basicUdiDi>59084472NL035ME</basicUdiDi>
    <tradeName>05908447232402</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ChM spółka z ograniczoną odpowiedzialnością</manufacturerName>
    <manufacturerSrn>PL-MF-000002121</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>L091202</emdnCode>
    <emdnDescription>ORTHOPAEDIC SURGERY FILES, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>40.6435.000</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-04T18:27:19.861Z</lastUpdated>
  </row>
</eudamedExport>