<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>05056385618229</udiDi>
    <basicUdiDi>50563856SSARC0214L</basicUdiDi>
    <tradeName>Stainless Steel Optima Orthodontic Archwire</tradeName>
    <deviceName>stainless steel archwire</deviceName>
    <manufacturerName>Ultimate Wireforms, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000013501</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q010405</emdnCode>
    <emdnDescription>ORTHODONTIC WIRES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SSARC</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:59:58.902Z</lastUpdated>
  </row>
  <row>
    <udiDi>05056385617291</udiDi>
    <basicUdiDi>50563856NTSPR016CA</basicUdiDi>
    <tradeName>Nickel Titanium Orthodontic Springs</tradeName>
    <deviceName>niti spring</deviceName>
    <manufacturerName>Ultimate Wireforms, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000013501</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q010405</emdnCode>
    <emdnDescription>ORTHODONTIC WIRES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NTSPR</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:59:58.112Z</lastUpdated>
  </row>
  <row>
    <udiDi>05056385617147</udiDi>
    <basicUdiDi>50563856NTUTL015D4</basicUdiDi>
    <tradeName>Nickel Titanium Orthodontic Archwire</tradeName>
    <deviceName>niti utility archwire</deviceName>
    <manufacturerName>Ultimate Wireforms, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000013501</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q010405</emdnCode>
    <emdnDescription>ORTHODONTIC WIRES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NTUTL</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:59:57.292Z</lastUpdated>
  </row>
  <row>
    <udiDi>05056385616911</udiDi>
    <basicUdiDi>50563856NTTOR014C8</basicUdiDi>
    <tradeName>Nickel Titanium Orthodontic Archwire</tradeName>
    <deviceName>niti torqued archwire</deviceName>
    <manufacturerName>Ultimate Wireforms, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000013501</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q010405</emdnCode>
    <emdnDescription>ORTHODONTIC WIRES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NTTOR</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:59:56.504Z</lastUpdated>
  </row>
  <row>
    <udiDi>05056385616867</udiDi>
    <basicUdiDi>50563856NTSPL013AS</basicUdiDi>
    <tradeName>Nickel Titanium Orthodontic Wire</tradeName>
    <deviceName>niti spool wire</deviceName>
    <manufacturerName>Ultimate Wireforms, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000013501</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q010405</emdnCode>
    <emdnDescription>ORTHODONTIC WIRES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NTSPL</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:59:55.702Z</lastUpdated>
  </row>
  <row>
    <udiDi>05056385616690</udiDi>
    <basicUdiDi>50563856NTSTR012DE</basicUdiDi>
    <tradeName>Nickel Titanium Orthodontic Wire</tradeName>
    <deviceName>niti straight wire</deviceName>
    <manufacturerName>Ultimate Wireforms, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000013501</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q010405</emdnCode>
    <emdnDescription>ORTHODONTIC WIRES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NTSTR</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:59:54.902Z</lastUpdated>
  </row>
  <row>
    <udiDi>05056385601009</udiDi>
    <basicUdiDi>50563856NTARC01123</basicUdiDi>
    <tradeName>Nickel Titanium Orthodontic Archwire</tradeName>
    <deviceName>niti archwire</deviceName>
    <manufacturerName>Ultimate Wireforms, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000013501</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q010405</emdnCode>
    <emdnDescription>ORTHODONTIC WIRES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NTARC</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:59:54.114Z</lastUpdated>
  </row>
  <row>
    <udiDi>05056385628358</udiDi>
    <basicUdiDi>50563856SSARC0214L</basicUdiDi>
    <tradeName>Stainless Steel Orthodontic Wire</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Ultimate Wireforms, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000013501</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Q010405</emdnCode>
    <emdnDescription>ORTHODONTIC WIRES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SSARC</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-19T14:22:18.254Z</lastUpdated>
  </row>
  <row>
    <udiDi>05056385628341</udiDi>
    <basicUdiDi>50563856SSARC0214L</basicUdiDi>
    <tradeName>Stainless Steel Orthodontic Wire</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Ultimate Wireforms, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000013501</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Q010405</emdnCode>
    <emdnDescription>ORTHODONTIC WIRES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SSARC</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-19T14:22:17.335Z</lastUpdated>
  </row>
  <row>
    <udiDi>05056385628334</udiDi>
    <basicUdiDi>50563856SSARC0214L</basicUdiDi>
    <tradeName>Stainless Steel Orthodontic Wire</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Ultimate Wireforms, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000013501</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Q010405</emdnCode>
    <emdnDescription>ORTHODONTIC WIRES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SSARC</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-19T14:22:16.452Z</lastUpdated>
  </row>
  <row>
    <udiDi>05056385628327</udiDi>
    <basicUdiDi>50563856SSARC0214L</basicUdiDi>
    <tradeName>Stainless Steel Orthodontic Wire</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Ultimate Wireforms, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000013501</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Q010405</emdnCode>
    <emdnDescription>ORTHODONTIC WIRES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SSARC</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-19T14:22:15.552Z</lastUpdated>
  </row>
  <row>
    <udiDi>05056385628310</udiDi>
    <basicUdiDi>50563856NTARC01123</basicUdiDi>
    <tradeName>Nickel Titanium Orthodontic Archwire</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Ultimate Wireforms, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000013501</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Q010405</emdnCode>
    <emdnDescription>ORTHODONTIC WIRES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NTARC</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-19T14:22:14.655Z</lastUpdated>
  </row>
  <row>
    <udiDi>05056385628303</udiDi>
    <basicUdiDi>50563856NTARC01123</basicUdiDi>
    <tradeName>Nickel Titanium Orthodontic Archwire</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Ultimate Wireforms, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000013501</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Q010405</emdnCode>
    <emdnDescription>ORTHODONTIC WIRES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NTARC</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-19T14:22:13.765Z</lastUpdated>
  </row>
  <row>
    <udiDi>05056385628297</udiDi>
    <basicUdiDi>50563856S3STR032XG</basicUdiDi>
    <tradeName>Stainless Steel Orthodontic Wire</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Ultimate Wireforms, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000013501</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Q010405</emdnCode>
    <emdnDescription>ORTHODONTIC WIRES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S3STR</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-19T14:22:12.833Z</lastUpdated>
  </row>
  <row>
    <udiDi>05056385628273</udiDi>
    <basicUdiDi>50563856SSSTR022FX</basicUdiDi>
    <tradeName>Stainless Steel Orthodontic Wire</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Ultimate Wireforms, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000013501</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Q010405</emdnCode>
    <emdnDescription>ORTHODONTIC WIRES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SSSTR</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-19T14:22:05.787Z</lastUpdated>
  </row>
  <row>
    <udiDi>05056385628266</udiDi>
    <basicUdiDi>50563856SSSTR022FX</basicUdiDi>
    <tradeName>Stainless Steel Orthodontic Wire</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Ultimate Wireforms, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000013501</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Q010405</emdnCode>
    <emdnDescription>ORTHODONTIC WIRES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SSSTR</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-19T14:22:04.902Z</lastUpdated>
  </row>
  <row>
    <udiDi>05056385628259</udiDi>
    <basicUdiDi>50563856SSSTR022FX</basicUdiDi>
    <tradeName>Stainless Steel Orthodontic Wire</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Ultimate Wireforms, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000013501</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Q010405</emdnCode>
    <emdnDescription>ORTHODONTIC WIRES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SSSTR</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-19T14:22:04.001Z</lastUpdated>
  </row>
  <row>
    <udiDi>05056385628242</udiDi>
    <basicUdiDi>50563856SSSTR022FX</basicUdiDi>
    <tradeName>Stainless Steel Orthodontic Wire</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Ultimate Wireforms, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000013501</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Q010405</emdnCode>
    <emdnDescription>ORTHODONTIC WIRES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SSSTR</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-19T14:22:03.088Z</lastUpdated>
  </row>
  <row>
    <udiDi>05056385628235</udiDi>
    <basicUdiDi>50563856SSSTR022FX</basicUdiDi>
    <tradeName>Stainless Steel Orthodontic Wire</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Ultimate Wireforms, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000013501</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Q010405</emdnCode>
    <emdnDescription>ORTHODONTIC WIRES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SSSTR</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-19T14:22:02.188Z</lastUpdated>
  </row>
  <row>
    <udiDi>05056385628228</udiDi>
    <basicUdiDi>50563856SSSTR022FX</basicUdiDi>
    <tradeName>Stainless Steel Orthodontic Wire</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Ultimate Wireforms, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000013501</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Q010405</emdnCode>
    <emdnDescription>ORTHODONTIC WIRES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SSSTR</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-19T14:22:01.302Z</lastUpdated>
  </row>
</eudamedExport>