<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>07540194012708</udiDi>
    <basicUdiDi>7540194FD-TTSP7</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>L26</emdnCode>
    <emdnDescription>SURGICAL SCREWDRIVERS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GIN-TRX800</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-03T02:21:20.670Z</lastUpdated>
  </row>
  <row>
    <udiDi>07540194012531</udiDi>
    <basicUdiDi>7540194FD-PGDLE</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 IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12130503</emdnCode>
    <emdnDescription>ORTHOPAEDIC SURGICAL DRILLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PEG-PGD120</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-03T02:21:19.871Z</lastUpdated>
  </row>
  <row>
    <udiDi>07540194012111</udiDi>
    <basicUdiDi>7540194FD-LPRA</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>P09120399</emdnCode>
    <emdnDescription>BONE FIXATION WIRES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FD-LCP-160</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-03T02:21:19.070Z</lastUpdated>
  </row>
  <row>
    <udiDi>07540194011954</udiDi>
    <basicUdiDi>7540194HP-EIMCNH</basicUdiDi>
    <tradeName>The Hinge Pediatric Plating 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>S010401</emdnCode>
    <emdnDescription>TRAYS, BASKETS, TUBS FOR STERILISATION AND THEIR COMPONENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HP-CYE100</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-03T02:21:18.269Z</lastUpdated>
  </row>
  <row>
    <udiDi>07540194010674</udiDi>
    <basicUdiDi>7540194DRP-PREVJ</basicUdiDi>
    <tradeName>Dr Paley’s Osteotomy 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>L090903</emdnCode>
    <emdnDescription>ORTHOPAEDIC SURGERY SCALPELS AND KNIVES, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DRPPE-602</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-03T02:21:14.260Z</lastUpdated>
  </row>
  <row>
    <udiDi>07540194010667</udiDi>
    <basicUdiDi>7540194DRP-OSTL3A</basicUdiDi>
    <tradeName>Dr Paley’s Osteotomy 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>L0903</emdnCode>
    <emdnDescription>ORTHOPAEDIC SURGERY HAMMERS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DRPOL-700</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-03T02:21:13.466Z</lastUpdated>
  </row>
  <row>
    <udiDi>07540194010629</udiDi>
    <basicUdiDi>7540194DRP-OSTT3S</basicUdiDi>
    <tradeName>Dr Paley’s Osteotomy 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>L090401</emdnCode>
    <emdnDescription>ORTHOPAEDIC SURGERY OSTEOTOMES, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DRPO-704</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-03T02:21:12.685Z</lastUpdated>
  </row>
  <row>
    <udiDi>07540194010575</udiDi>
    <basicUdiDi>7540194DRP-GGPTS</basicUdiDi>
    <tradeName>Dr Paley’s Osteotomy 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>DRPGP-501</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-03T02:21:11.882Z</lastUpdated>
  </row>
  <row>
    <udiDi>07540194010568</udiDi>
    <basicUdiDi>7540194DRP-FOT5</basicUdiDi>
    <tradeName>Dr Paley’s Osteotomy 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>DRPFO-102</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-03T02:21:07.860Z</lastUpdated>
  </row>
  <row>
    <udiDi>07540194010551</udiDi>
    <basicUdiDi>7540194DRP-FSTUZ</basicUdiDi>
    <tradeName>Dr Paley’s Osteotomy 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>L090903</emdnCode>
    <emdnDescription>ORTHOPAEDIC SURGERY SCALPELS AND KNIVES, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DRPF-601</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-03T02:21:07.058Z</lastUpdated>
  </row>
  <row>
    <udiDi>07540194010544</udiDi>
    <basicUdiDi>7540194DRP-DGSF</basicUdiDi>
    <tradeName>Dr Paley’s Osteotomy 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>DRPDG-301</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-03T02:21:06.261Z</lastUpdated>
  </row>
  <row>
    <udiDi>07540194010520</udiDi>
    <basicUdiDi>7540194DRP-DRT5</basicUdiDi>
    <tradeName>Dr Paley’s Osteotomy 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 IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12130503</emdnCode>
    <emdnDescription>ORTHOPAEDIC SURGICAL DRILLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DRPCD-448</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-03T02:21:05.458Z</lastUpdated>
  </row>
  <row>
    <udiDi>07540194010513</udiDi>
    <basicUdiDi>7540194DRP-CCS4</basicUdiDi>
    <tradeName>Dr Paley’s Osteotomy 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>L091103</emdnCode>
    <emdnDescription>ORTHOPAEDIC PROSTHESES FORCEPS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DRPCC-202</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-03T02:21:01.451Z</lastUpdated>
  </row>
  <row>
    <udiDi>07540194010506</udiDi>
    <basicUdiDi>7540194DRP-BCMPVF</basicUdiDi>
    <tradeName>Dr Paley’s Osteotomy 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>L0923</emdnCode>
    <emdnDescription>ORTHOPAEDICS SURGICAL MEASURERS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DRPBC-101</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-03T02:21:00.666Z</lastUpdated>
  </row>
  <row>
    <udiDi>07540194010490</udiDi>
    <basicUdiDi>7540194DRP-PINV9</basicUdiDi>
    <tradeName>Dr Paley’s Osteotomy 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>L098099</emdnCode>
    <emdnDescription>ORTHOPAEDIC AND TRAUMATOLOGICAL SURGERY INSTRUMENTS, REUSABLE - OTHER ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DRPAP-902</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-03T02:20:59.851Z</lastUpdated>
  </row>
  <row>
    <udiDi>07540194010469</udiDi>
    <basicUdiDi>7540194DRP-EINCWB</basicUdiDi>
    <tradeName>Dr Paley’s Osteotomy 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>L0919</emdnCode>
    <emdnDescription>ORTHOPAEDIC AND TRAUMATOLOGICAL SURGERY INSTRUMENT KITS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DRP-CASE</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-03T02:20:59.061Z</lastUpdated>
  </row>
  <row>
    <udiDi>07540194010346</udiDi>
    <basicUdiDi>7540194GAP-GNTPD</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>L0923</emdnCode>
    <emdnDescription>ORTHOPAEDICS SURGICAL MEASURERS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GAP-TPL100</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-03T02:20:55.043Z</lastUpdated>
  </row>
  <row>
    <udiDi>07540194010339</udiDi>
    <basicUdiDi>7540194GAP-TPRTUV</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-TP116</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-03T02:20:54.247Z</lastUpdated>
  </row>
  <row>
    <udiDi>07540194010315</udiDi>
    <basicUdiDi>7540194GAP-SDRVSW</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>L26</emdnCode>
    <emdnDescription>SURGICAL SCREWDRIVERS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GAP-TLS100</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-03T02:20:53.449Z</lastUpdated>
  </row>
  <row>
    <udiDi>07540194010308</udiDi>
    <basicUdiDi>7540194GAP-AHML</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-THA100</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-03T02:20:52.652Z</lastUpdated>
  </row>
</eudamedExport>