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<eudamedExport entity="devices">
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    <udiDi>07540194006738</udiDi>
    <basicUdiDi>7540194FD-DISCGW</basicUdiDi>
    <tradeName>The Fassier-Duval Telescopic IM 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>L090999</emdnCode>
    <emdnDescription>ORTHOPAEDIC SURGERY CUTTING INSTRUMENTS, REUSABLE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FC-DISC</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-03T02:17:17.100Z</lastUpdated>
  </row>
  <row>
    <udiDi>07540194006721</udiDi>
    <basicUdiDi>7540194FD-BURRK7</basicUdiDi>
    <tradeName>The Fassier-Duval Telescopic IM 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>L090999</emdnCode>
    <emdnDescription>ORTHOPAEDIC SURGERY CUTTING INSTRUMENTS, REUSABLE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FC-BURR</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-03T02:17:16.301Z</lastUpdated>
  </row>
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    <udiDi>07540194006691</udiDi>
    <basicUdiDi>7540194POP-CNTZ8</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 IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>P09120402</emdnCode>
    <emdnDescription>SCREWS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>POP-M3I</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-03T02:17:15.520Z</lastUpdated>
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  <row>
    <udiDi>07540194005090</udiDi>
    <basicUdiDi>7540194POP-BLDXV</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 IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>P09120504</emdnCode>
    <emdnDescription>OSTEOSYNTHESIS BLADE-PLATE SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>POP-AB-40</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-03T02:17:14.701Z</lastUpdated>
  </row>
  <row>
    <udiDi>07540194004987</udiDi>
    <basicUdiDi>7540194POP-SCW2Y</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 IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>P09120601</emdnCode>
    <emdnDescription>CORTICAL SCREWS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>POP-OB45-20</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-03T02:17:10.703Z</lastUpdated>
  </row>
  <row>
    <udiDi>07540194004864</udiDi>
    <basicUdiDi>7540194POP-PLT36</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 IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>P09120504</emdnCode>
    <emdnDescription>OSTEOSYNTHESIS BLADE-PLATE SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>POP-HVR-090</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-03T02:17:09.912Z</lastUpdated>
  </row>
  <row>
    <udiDi>07540194002235</udiDi>
    <basicUdiDi>7540194GAP-SSNRC</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 IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>P9099</emdnCode>
    <emdnDescription>IMPLANTABLE PROSTHETIC DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GAP-SSN55</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-03T02:17:09.101Z</lastUpdated>
  </row>
  <row>
    <udiDi>07540194002181</udiDi>
    <basicUdiDi>7540194GAP-CAPMA</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 IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>P09120402</emdnCode>
    <emdnDescription>SCREWS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GAP-CP015</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-03T02:17:08.292Z</lastUpdated>
  </row>
  <row>
    <udiDi>07540194002136</udiDi>
    <basicUdiDi>7540194GAP-PLTQL</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 IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>P09120599</emdnCode>
    <emdnDescription>BONE FIXATION PLATES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GAP-PLC110</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-03T02:17:04.291Z</lastUpdated>
  </row>
  <row>
    <udiDi>07540194002129</udiDi>
    <basicUdiDi>7540194GAP-WSHRL</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 IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>P9099</emdnCode>
    <emdnDescription>IMPLANTABLE PROSTHETIC DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GAP-WAS100</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-03T02:17:03.490Z</lastUpdated>
  </row>
  <row>
    <udiDi>07540194001108</udiDi>
    <basicUdiDi>7540194GAP-SCWQE</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 IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>P09120402</emdnCode>
    <emdnDescription>SCREWS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GAP-LG050</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-03T02:17:02.692Z</lastUpdated>
  </row>
  <row>
    <udiDi>07540194000712</udiDi>
    <basicUdiDi>7540194GAP-NAILSZQ</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 IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>P09120201</emdnCode>
    <emdnDescription>INTRAMEDULLARY NAILS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GAP-N48-16</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-03T02:17:01.894Z</lastUpdated>
  </row>
  <row>
    <udiDi>07540194000590</udiDi>
    <basicUdiDi>7540194HP-SCWSM</basicUdiDi>
    <tradeName>The Hinge Pediatric Plating System</tradeName>
    <deviceName>SCREW 20MM LENGTH</deviceName>
    <manufacturerName>OrthoPediatrics Canada ULC</manufacturerName>
    <manufacturerSrn>CA-MF-000013010</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>P09120601</emdnCode>
    <emdnDescription>CORTICAL SCREWS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HPS020-PKG2</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-03T02:16:57.889Z</lastUpdated>
  </row>
  <row>
    <udiDi>07540194000569</udiDi>
    <basicUdiDi>7540194HP-PLTST</basicUdiDi>
    <tradeName>The Hinge Pediatric Plating System</tradeName>
    <deviceName>SMALL PLATE 12MM LENGTH</deviceName>
    <manufacturerName>OrthoPediatrics Canada ULC</manufacturerName>
    <manufacturerSrn>CA-MF-000013010</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>P09120599</emdnCode>
    <emdnDescription>BONE FIXATION PLATES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HPI012</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-03T02:16:57.087Z</lastUpdated>
  </row>
  <row>
    <udiDi>07540194000019</udiDi>
    <basicUdiDi>7540194FD-NAILSM7</basicUdiDi>
    <tradeName>The Fassier-Duval Telescopic IM 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 IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>P09120201</emdnCode>
    <emdnDescription>INTRAMEDULLARY NAILS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>F032-SS</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-03T02:16:56.296Z</lastUpdated>
  </row>
  <row>
    <udiDi>07540194000026</udiDi>
    <basicUdiDi>7540194FD-NAILSM7</basicUdiDi>
    <tradeName>The Fassier-Duval Telescopic IM 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 IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>P09120201</emdnCode>
    <emdnDescription>INTRAMEDULLARY NAILS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>F040-SS</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T07:19:13.201Z</lastUpdated>
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    <udiDi>07540194000033</udiDi>
    <basicUdiDi>7540194FD-NAILSM7</basicUdiDi>
    <tradeName>The Fassier-Duval Telescopic IM 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 IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>P09120201</emdnCode>
    <emdnDescription>INTRAMEDULLARY NAILS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>F048-SS</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T07:19:13.185Z</lastUpdated>
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    <udiDi>07540194000040</udiDi>
    <basicUdiDi>7540194FD-NAILSM7</basicUdiDi>
    <tradeName>The Fassier-Duval Telescopic IM 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 IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>P09120201</emdnCode>
    <emdnDescription>INTRAMEDULLARY NAILS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>F056-SS</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T07:19:13.166Z</lastUpdated>
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    <udiDi>07540194000057</udiDi>
    <basicUdiDi>7540194FD-NAILSM7</basicUdiDi>
    <tradeName>The Fassier-Duval Telescopic IM 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 IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>P09120201</emdnCode>
    <emdnDescription>INTRAMEDULLARY NAILS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>F064-SS</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T07:19:13.145Z</lastUpdated>
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    <udiDi>07540194000064</udiDi>
    <basicUdiDi>7540194FD-NAILSM7</basicUdiDi>
    <tradeName>The Fassier-Duval Telescopic IM 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 IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>P09120201</emdnCode>
    <emdnDescription>INTRAMEDULLARY NAILS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>M032-SS-100</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T07:19:13.127Z</lastUpdated>
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