<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>08056249734451</udiDi>
    <basicUdiDi>805624973FRESEFY</basicUdiDi>
    <tradeName>08056249734451</tradeName>
    <deviceName>Fresa</deviceName>
    <manufacturerName>BONE SYSTEM SRL</manufacturerName>
    <manufacturerSrn>IT-MF-000040985</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>L1508</emdnCode>
    <emdnDescription>REAMERS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>84000</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T08:11:37.044Z</lastUpdated>
  </row>
  <row>
    <udiDi>08056591034599</udiDi>
    <basicUdiDi>8055510171100VZ</basicUdiDi>
    <tradeName>Twist Drill STN w/ Stop Ø 2.0</tradeName>
    <deviceName></deviceName>
    <manufacturerName>J Dental Care Srl</manufacturerName>
    <manufacturerSrn>IT-MF-000029459</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>L1508</emdnCode>
    <emdnDescription>REAMERS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>JDDR20STN</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T07:36:59.105Z</lastUpdated>
  </row>
  <row>
    <udiDi>07540194010940</udiDi>
    <basicUdiDi>7540194SLM-CRWE</basicUdiDi>
    <tradeName>The Simple Locking Intra 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 IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>L1508</emdnCode>
    <emdnDescription>REAMERS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SLM-CNR101</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-03T02:25:01.515Z</lastUpdated>
  </row>
  <row>
    <udiDi>07540194008312</udiDi>
    <basicUdiDi>7540194SLM-RZN</basicUdiDi>
    <tradeName>The Simple Locking Intra 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 IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>L1508</emdnCode>
    <emdnDescription>REAMERS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SLM-DCA032</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-03T02:24:48.701Z</lastUpdated>
  </row>
  <row>
    <udiDi>07540194007773</udiDi>
    <basicUdiDi>7540194SCFE-DRT7</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 IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>L1508</emdnCode>
    <emdnDescription>REAMERS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SCF-CAR050</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-03T02:24:41.502Z</lastUpdated>
  </row>
  <row>
    <udiDi>07540194009920</udiDi>
    <basicUdiDi>7540194GAP-CORNQ</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 IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>L1508</emdnCode>
    <emdnDescription>REAMERS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GAP-DTP052</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-03T02:20:05.365Z</lastUpdated>
  </row>
  <row>
    <udiDi>07540194009807</udiDi>
    <basicUdiDi>7540194GAP-EMNA</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 IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>L1508</emdnCode>
    <emdnDescription>REAMERS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GAP-DCE100</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-03T02:19:54.154Z</lastUpdated>
  </row>
  <row>
    <udiDi>07540194009753</udiDi>
    <basicUdiDi>7540194GAP-CRNE</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 IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>L1508</emdnCode>
    <emdnDescription>REAMERS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GAP-DCA048</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-03T02:19:53.361Z</lastUpdated>
  </row>
  <row>
    <udiDi>08056591034605</udiDi>
    <basicUdiDi>8055510171100VZ</basicUdiDi>
    <tradeName>Twist Drill STN w/ Stop Ø 2.4</tradeName>
    <deviceName></deviceName>
    <manufacturerName>J Dental Care Srl</manufacturerName>
    <manufacturerSrn>IT-MF-000029459</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>L1508</emdnCode>
    <emdnDescription>REAMERS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>JDDR24STN</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-17T19:49:33.356Z</lastUpdated>
  </row>
  <row>
    <udiDi>08056591034612</udiDi>
    <basicUdiDi>8055510171100VZ</basicUdiDi>
    <tradeName>Twist Drill STN w/ Stop Ø 2.8</tradeName>
    <deviceName></deviceName>
    <manufacturerName>J Dental Care Srl</manufacturerName>
    <manufacturerSrn>IT-MF-000029459</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>L1508</emdnCode>
    <emdnDescription>REAMERS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>JDDR28STN</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-17T19:49:33.337Z</lastUpdated>
  </row>
  <row>
    <udiDi>08056591034629</udiDi>
    <basicUdiDi>8055510171100VZ</basicUdiDi>
    <tradeName>Twist Drill STN w/ Stop Ø 3.2</tradeName>
    <deviceName></deviceName>
    <manufacturerName>J Dental Care Srl</manufacturerName>
    <manufacturerSrn>IT-MF-000029459</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>L1508</emdnCode>
    <emdnDescription>REAMERS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>JDDR32STN</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-17T19:49:33.322Z</lastUpdated>
  </row>
  <row>
    <udiDi>08056591034636</udiDi>
    <basicUdiDi>8055510171100VZ</basicUdiDi>
    <tradeName>Twist Drill STN w/ Stop Ø 3.6</tradeName>
    <deviceName></deviceName>
    <manufacturerName>J Dental Care Srl</manufacturerName>
    <manufacturerSrn>IT-MF-000029459</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>L1508</emdnCode>
    <emdnDescription>REAMERS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>JDDR36STN</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-17T19:49:33.308Z</lastUpdated>
  </row>
  <row>
    <udiDi>08056591034643</udiDi>
    <basicUdiDi>8055510171100VZ</basicUdiDi>
    <tradeName>Twist Drill STN w/ Stop Ø 4.0</tradeName>
    <deviceName></deviceName>
    <manufacturerName>J Dental Care Srl</manufacturerName>
    <manufacturerSrn>IT-MF-000029459</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>L1508</emdnCode>
    <emdnDescription>REAMERS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>JDDR40STN</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-17T19:49:33.283Z</lastUpdated>
  </row>
  <row>
    <udiDi>08056591034650</udiDi>
    <basicUdiDi>8055510171100VZ</basicUdiDi>
    <tradeName>Twist Drill STN w/ Stop Ø 4.4</tradeName>
    <deviceName></deviceName>
    <manufacturerName>J Dental Care Srl</manufacturerName>
    <manufacturerSrn>IT-MF-000029459</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>L1508</emdnCode>
    <emdnDescription>REAMERS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>JDDR44STN</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-17T19:49:33.263Z</lastUpdated>
  </row>
  <row>
    <udiDi>08056591034667</udiDi>
    <basicUdiDi>8055510171100VZ</basicUdiDi>
    <tradeName>Twist Drill STN w/ Stop Ø 4.8</tradeName>
    <deviceName></deviceName>
    <manufacturerName>J Dental Care Srl</manufacturerName>
    <manufacturerSrn>IT-MF-000029459</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>L1508</emdnCode>
    <emdnDescription>REAMERS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>JDDR48STN</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-17T19:49:33.233Z</lastUpdated>
  </row>
  <row>
    <udiDi>07540194007780</udiDi>
    <basicUdiDi>7540194SCFE-DRT7</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 IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>L1508</emdnCode>
    <emdnDescription>REAMERS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SCF-CAR065</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T07:18:51.299Z</lastUpdated>
  </row>
  <row>
    <udiDi>07540194007797</udiDi>
    <basicUdiDi>7540194SCFE-DRT7</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 IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>L1508</emdnCode>
    <emdnDescription>REAMERS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SCF-CAR073</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T07:18:51.273Z</lastUpdated>
  </row>
  <row>
    <udiDi>07540194008329</udiDi>
    <basicUdiDi>7540194SLM-RZN</basicUdiDi>
    <tradeName>The Simple Locking Intra 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 IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>L1508</emdnCode>
    <emdnDescription>REAMERS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SLM-DCA040</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T07:18:39.651Z</lastUpdated>
  </row>
  <row>
    <udiDi>07540194008336</udiDi>
    <basicUdiDi>7540194SLM-RZN</basicUdiDi>
    <tradeName>The Simple Locking Intra 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 IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>L1508</emdnCode>
    <emdnDescription>REAMERS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SLM-DCA048</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T07:18:39.628Z</lastUpdated>
  </row>
  <row>
    <udiDi>07540194008343</udiDi>
    <basicUdiDi>7540194SLM-RZN</basicUdiDi>
    <tradeName>The Simple Locking Intra 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 IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>L1508</emdnCode>
    <emdnDescription>REAMERS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SLM-DCA056</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T07:18:39.611Z</lastUpdated>
  </row>
</eudamedExport>