<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>07540194010193</udiDi>
    <basicUdiDi>7540194GAP-GWSQ6</basicUdiDi>
    <tradeName>The GAP Nail Endo-Exo Medullary System</tradeName>
    <deviceName></deviceName>
    <manufacturerName>OrthoPediatrics Canada ULC</manufacturerName>
    <manufacturerSrn>CA-MF-000013010</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>L0922</emdnCode>
    <emdnDescription>ORTHOPAEDIC SURGERY GUIDES, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GAP-SGW116</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-03T02:20:32.587Z</lastUpdated>
  </row>
  <row>
    <udiDi>07540194010186</udiDi>
    <basicUdiDi>7540194GAP-DGSN7</basicUdiDi>
    <tradeName>The GAP Nail Endo-Exo Medullary System</tradeName>
    <deviceName></deviceName>
    <manufacturerName>OrthoPediatrics Canada ULC</manufacturerName>
    <manufacturerSrn>CA-MF-000013010</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>L0922</emdnCode>
    <emdnDescription>ORTHOPAEDIC SURGERY GUIDES, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GAP-SDG120</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-03T02:20:31.789Z</lastUpdated>
  </row>
  <row>
    <udiDi>07540194010179</udiDi>
    <basicUdiDi>7540194GAP-SLVR7</basicUdiDi>
    <tradeName>The GAP Nail Endo-Exo Medullary System</tradeName>
    <deviceName></deviceName>
    <manufacturerName>OrthoPediatrics Canada ULC</manufacturerName>
    <manufacturerSrn>CA-MF-000013010</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>L0922</emdnCode>
    <emdnDescription>ORTHOPAEDIC SURGERY GUIDES, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GAP-SCS100</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-03T02:20:30.999Z</lastUpdated>
  </row>
  <row>
    <udiDi>07540194010100</udiDi>
    <basicUdiDi>7540194GAP-LOGPF</basicUdiDi>
    <tradeName>The GAP Nail Endo-Exo Medullary System</tradeName>
    <deviceName></deviceName>
    <manufacturerName>OrthoPediatrics Canada ULC</manufacturerName>
    <manufacturerSrn>CA-MF-000013010</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>L0922</emdnCode>
    <emdnDescription>ORTHOPAEDIC SURGERY GUIDES, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GAP-LGO100</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-03T02:20:19.778Z</lastUpdated>
  </row>
  <row>
    <udiDi>07540194009722</udiDi>
    <basicUdiDi>7540194GAP-APAMF</basicUdiDi>
    <tradeName>The GAP Nail Endo-Exo Medullary System</tradeName>
    <deviceName></deviceName>
    <manufacturerName>OrthoPediatrics Canada ULC</manufacturerName>
    <manufacturerSrn>CA-MF-000013010</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>L0922</emdnCode>
    <emdnDescription>ORTHOPAEDIC SURGERY GUIDES, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GAP-APA100</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-03T02:19:36.512Z</lastUpdated>
  </row>
  <row>
    <udiDi>07540194009357</udiDi>
    <basicUdiDi>7540194POP-WGY3</basicUdiDi>
    <tradeName>The Locking Pediatric Osteotomy Plate system</tradeName>
    <deviceName></deviceName>
    <manufacturerName>OrthoPediatrics Canada ULC</manufacturerName>
    <manufacturerSrn>CA-MF-000013010</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>L0922</emdnCode>
    <emdnDescription>ORTHOPAEDIC SURGERY GUIDES, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>POP-WGD100</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-03T02:19:35.716Z</lastUpdated>
  </row>
  <row>
    <udiDi>07540194009258</udiDi>
    <basicUdiDi>7540194POP-LSXS</basicUdiDi>
    <tradeName>The Locking Pediatric Osteotomy Plate system</tradeName>
    <deviceName></deviceName>
    <manufacturerName>OrthoPediatrics Canada ULC</manufacturerName>
    <manufacturerSrn>CA-MF-000013010</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>L0922</emdnCode>
    <emdnDescription>ORTHOPAEDIC SURGERY GUIDES, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>POP-SLV127</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-03T02:19:30.096Z</lastUpdated>
  </row>
  <row>
    <udiDi>07540194009173</udiDi>
    <basicUdiDi>7540194POP-OSTGDM7</basicUdiDi>
    <tradeName>The Locking Pediatric Osteotomy Plate system</tradeName>
    <deviceName></deviceName>
    <manufacturerName>OrthoPediatrics Canada ULC</manufacturerName>
    <manufacturerSrn>CA-MF-000013010</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>L0922</emdnCode>
    <emdnDescription>ORTHOPAEDIC SURGERY GUIDES, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>POP-OTG200</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-03T02:19:24.496Z</lastUpdated>
  </row>
  <row>
    <udiDi>07540194009142</udiDi>
    <basicUdiDi>7540194POP-DGWA</basicUdiDi>
    <tradeName>The Locking Pediatric Osteotomy Plate system</tradeName>
    <deviceName></deviceName>
    <manufacturerName>OrthoPediatrics Canada ULC</manufacturerName>
    <manufacturerSrn>CA-MF-000013010</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>L0922</emdnCode>
    <emdnDescription>ORTHOPAEDIC SURGERY GUIDES, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>POP-OBL200</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-03T02:19:23.691Z</lastUpdated>
  </row>
  <row>
    <udiDi>07540194008923</udiDi>
    <basicUdiDi>7540194POP-CBRK3A</basicUdiDi>
    <tradeName>The Locking Pediatric Osteotomy Plate system</tradeName>
    <deviceName></deviceName>
    <manufacturerName>OrthoPediatrics Canada ULC</manufacturerName>
    <manufacturerSrn>CA-MF-000013010</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>L0922</emdnCode>
    <emdnDescription>ORTHOPAEDIC SURGERY GUIDES, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>POP-CBK200</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-03T02:18:58.876Z</lastUpdated>
  </row>
  <row>
    <udiDi>07540194007872</udiDi>
    <basicUdiDi>7540194SCF-GWSTW</basicUdiDi>
    <tradeName>The Free Gliding SCFE Screw System</tradeName>
    <deviceName></deviceName>
    <manufacturerName>OrthoPediatrics Canada ULC</manufacturerName>
    <manufacturerSrn>CA-MF-000013010</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>L0922</emdnCode>
    <emdnDescription>ORTHOPAEDIC SURGERY GUIDES, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SCF-GWS150</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-03T02:18:24.414Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975610801283</udiDi>
    <basicUdiDi>69756108001400YC</basicUdiDi>
    <tradeName>06975610801283</tradeName>
    <deviceName>Nails Guide Device Component Part</deviceName>
    <manufacturerName>Changzhou Centrau Medical Instrument Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000027491</manufacturerSrn>
    <authorisedRepresentativeName>phoenix Medtech GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000007996</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>L0922</emdnCode>
    <emdnDescription>ORTHOPAEDIC SURGERY GUIDES, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>XCN01</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-02T16:23:14.977Z</lastUpdated>
  </row>
  <row>
    <udiDi>06941832543546</udiDi>
    <basicUdiDi>69418325P2021036099F</basicUdiDi>
    <tradeName>06941832543546</tradeName>
    <deviceName>Reusable Surgical Instruments</deviceName>
    <manufacturerName>Hangzhou Rejoin Mastin Medical Device Co.，Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000006572</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>L0922</emdnCode>
    <emdnDescription>ORTHOPAEDIC SURGERY GUIDES, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RJ8107032</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T07:34:59.525Z</lastUpdated>
  </row>
  <row>
    <udiDi>04049113079141</udiDi>
    <basicUdiDi>404911318501R0020010015R</basicUdiDi>
    <tradeName>04049113079141</tradeName>
    <deviceName>Guide, Führung</deviceName>
    <manufacturerName>ELCON Medical Instruments GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005908</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>L0922</emdnCode>
    <emdnDescription>ORTHOPAEDIC SURGERY GUIDES, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>340-835</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T15:54:57.937Z</lastUpdated>
  </row>
  <row>
    <udiDi>04048844542948</udiDi>
    <basicUdiDi>4048844KNU7TCBINSTVH</basicUdiDi>
    <tradeName>04048844542948</tradeName>
    <deviceName>-</deviceName>
    <manufacturerName>implantcast GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000010002</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>L0922</emdnCode>
    <emdnDescription>ORTHOPAEDIC SURGERY GUIDES, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>42160370</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T15:40:09.550Z</lastUpdated>
  </row>
  <row>
    <udiDi>04048844477998</udiDi>
    <basicUdiDi>4048844KNU7SGRGINSTZ3</basicUdiDi>
    <tradeName>ACS® UNI</tradeName>
    <deviceName>-</deviceName>
    <manufacturerName>implantcast GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000010002</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>L0922</emdnCode>
    <emdnDescription>ORTHOPAEDIC SURGERY GUIDES, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>42160341</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-01T15:40:03.156Z</lastUpdated>
  </row>
  <row>
    <udiDi>04048844435165</udiDi>
    <basicUdiDi>4048844KNU9URAGINST2Q</basicUdiDi>
    <tradeName>ACS® UNI</tradeName>
    <deviceName>-</deviceName>
    <manufacturerName>implantcast GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000010002</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>L0922</emdnCode>
    <emdnDescription>ORTHOPAEDIC SURGERY GUIDES, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>42161701</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T15:39:41.660Z</lastUpdated>
  </row>
  <row>
    <udiDi>04048844435066</udiDi>
    <basicUdiDi>4048844KNU9UTAGINST3S</basicUdiDi>
    <tradeName>ACS® UNI</tradeName>
    <deviceName>-</deviceName>
    <manufacturerName>implantcast GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000010002</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>L0922</emdnCode>
    <emdnDescription>ORTHOPAEDIC SURGERY GUIDES, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>42161720</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T15:39:36.679Z</lastUpdated>
  </row>
  <row>
    <udiDi>04048844233532</udiDi>
    <basicUdiDi>4048844KNU9UFRGINST39</basicUdiDi>
    <tradeName>ACS® UNI</tradeName>
    <deviceName>-</deviceName>
    <manufacturerName>implantcast GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000010002</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>L0922</emdnCode>
    <emdnDescription>ORTHOPAEDIC SURGERY GUIDES, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>42160701</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T15:39:04.665Z</lastUpdated>
  </row>
  <row>
    <udiDi>04048844117979</udiDi>
    <basicUdiDi>4048844MUTART09AISRINSTY2</basicUdiDi>
    <tradeName>MUTARS® RS</tradeName>
    <deviceName>-</deviceName>
    <manufacturerName>implantcast GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000010002</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>L0922</emdnCode>
    <emdnDescription>ORTHOPAEDIC SURGERY GUIDES, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>77700014</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T15:38:18.221Z</lastUpdated>
  </row>
</eudamedExport>