<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>00855369008668</udiDi>
    <basicUdiDi>081005552TrephineBT</basicUdiDi>
    <tradeName>00855369008668</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SI-BONE, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000028624</manufacturerSrn>
    <authorisedRepresentativeName>ICON (LR) Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006507</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>L090902</emdnCode>
    <emdnDescription>ORTHOPAEDIC SURGERY TREPHINES, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>501252</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T20:19:26.938Z</lastUpdated>
  </row>
  <row>
    <udiDi>05056111337967</udiDi>
    <basicUdiDi>50554459CUTTINGINSTRL2</basicUdiDi>
    <tradeName>Champy Bone Biopsy Instrument Set Consisting of Trocar, a Toothed Trephine And a Plunger Reamer 22 cm - 8 1/2" Stainless Steel</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Surtex Instruments Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000023183</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>L090902</emdnCode>
    <emdnDescription>ORTHOPAEDIC SURGERY TREPHINES, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OR-022-00</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-19T11:01:38.272Z</lastUpdated>
  </row>
  <row>
    <udiDi>05056111335925</udiDi>
    <basicUdiDi>50554459CUTTINGINSTRL2</basicUdiDi>
    <tradeName>Ralk Hand Drill Longitudinally Board With 3 Jaw Chuck and Key - Light Metal housing - Opening up to Ø 6 mm Stainless Steel</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Surtex Instruments Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000023183</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>L090902</emdnCode>
    <emdnDescription>ORTHOPAEDIC SURGERY TREPHINES, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OR-096-00 L</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-19T10:57:06.843Z</lastUpdated>
  </row>
  <row>
    <udiDi>05056111319581</udiDi>
    <basicUdiDi>50554459CUTTINGINSTRL2</basicUdiDi>
    <tradeName>Twist Drill Smooth Shaft Ø 5.5 mm Stainless Steel</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Surtex Instruments Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000023183</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>L090902</emdnCode>
    <emdnDescription>ORTHOPAEDIC SURGERY TREPHINES, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OR-070-55</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-19T10:50:58.722Z</lastUpdated>
  </row>
  <row>
    <udiDi>05056111309544</udiDi>
    <basicUdiDi>50554459CUTTINGINSTRL2</basicUdiDi>
    <tradeName>T-Bar Tap 4.5 mm Stainless Steel</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Surtex Instruments Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000023183</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>L090902</emdnCode>
    <emdnDescription>ORTHOPAEDIC SURGERY TREPHINES, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OR-099-45</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-19T10:39:11.403Z</lastUpdated>
  </row>
  <row>
    <udiDi>05056111309520</udiDi>
    <basicUdiDi>50554459CUTTINGINSTRL2</basicUdiDi>
    <tradeName>T-Bar Tap 2.5 mm Stainless Steel</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Surtex Instruments Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000023183</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>L090902</emdnCode>
    <emdnDescription>ORTHOPAEDIC SURGERY TREPHINES, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OR-099-25</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-19T10:39:10.499Z</lastUpdated>
  </row>
  <row>
    <udiDi>05056111309513</udiDi>
    <basicUdiDi>50554459CUTTINGINSTRL2</basicUdiDi>
    <tradeName>T-Bar Tap 3.5 mm Stainless Steel</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Surtex Instruments Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000023183</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>L090902</emdnCode>
    <emdnDescription>ORTHOPAEDIC SURGERY TREPHINES, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OR-099-35</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-19T10:39:09.603Z</lastUpdated>
  </row>
  <row>
    <udiDi>05055445946265</udiDi>
    <basicUdiDi>50554459CUTTINGINSTRL2</basicUdiDi>
    <tradeName>Spare Drill Large Stainless Steel</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Surtex Instruments Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000023183</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>L090902</emdnCode>
    <emdnDescription>ORTHOPAEDIC SURGERY TREPHINES, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OR-992-03</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-19T06:08:04.368Z</lastUpdated>
  </row>
  <row>
    <udiDi>05055445946241</udiDi>
    <basicUdiDi>50554459CUTTINGINSTRL2</basicUdiDi>
    <tradeName>Spare Drill Small Stainless Steel</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Surtex Instruments Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000023183</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>L090902</emdnCode>
    <emdnDescription>ORTHOPAEDIC SURGERY TREPHINES, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OR-992-01</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-19T06:07:55.542Z</lastUpdated>
  </row>
  <row>
    <udiDi>05055445946234</udiDi>
    <basicUdiDi>50554459CUTTINGINSTRL2</basicUdiDi>
    <tradeName>Ideal Finger Nail Drill Complete With Drills Ref: OR-992-01 to OR-992-03 Stainless Steel</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Surtex Instruments Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000023183</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>L090902</emdnCode>
    <emdnDescription>ORTHOPAEDIC SURGERY TREPHINES, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OR-992-00</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-19T06:07:54.643Z</lastUpdated>
  </row>
  <row>
    <udiDi>05055445937423</udiDi>
    <basicUdiDi>50554459CUTTINGINSTRL2</basicUdiDi>
    <tradeName>Key Stainless Steel</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Surtex Instruments Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000023183</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>L090902</emdnCode>
    <emdnDescription>ORTHOPAEDIC SURGERY TREPHINES, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OR-098-00</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-19T05:46:37.163Z</lastUpdated>
  </row>
  <row>
    <udiDi>05055445937416</udiDi>
    <basicUdiDi>50554459CUTTINGINSTRL2</basicUdiDi>
    <tradeName>Ralk Hand Drill Longitudinally Board With 3 Jaw Chuck and Key - Light Metal housing - Opening up to Ø 4 mm Stainless Steel</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Surtex Instruments Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000023183</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>L090902</emdnCode>
    <emdnDescription>ORTHOPAEDIC SURGERY TREPHINES, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OR-096-00</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-19T05:46:36.261Z</lastUpdated>
  </row>
  <row>
    <udiDi>05055445937409</udiDi>
    <basicUdiDi>50554459CUTTINGINSTRL2</basicUdiDi>
    <tradeName>Bunnell Hand Drill Longitudinally Board With 3 Jaw Chuck and Key - Light Metal Housing - Opening up to Ø 4 mm Stainless Steel</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Surtex Instruments Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000023183</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>L090902</emdnCode>
    <emdnDescription>ORTHOPAEDIC SURGERY TREPHINES, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OR-094-00</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-19T05:46:35.360Z</lastUpdated>
  </row>
  <row>
    <udiDi>05055445937393</udiDi>
    <basicUdiDi>50554459CUTTINGINSTRL2</basicUdiDi>
    <tradeName>Toti Trephine Short Borchardt Shaft Ø 8.0 mm Stainless Steel</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Surtex Instruments Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000023183</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>L090902</emdnCode>
    <emdnDescription>ORTHOPAEDIC SURGERY TREPHINES, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OR-090-08</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-19T05:46:34.471Z</lastUpdated>
  </row>
  <row>
    <udiDi>05055445937386</udiDi>
    <basicUdiDi>50554459CUTTINGINSTRL2</basicUdiDi>
    <tradeName>Flat Burr Short Borchardt Shaft Ø 25.0 mm Stainless Steel</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Surtex Instruments Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000023183</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>L090902</emdnCode>
    <emdnDescription>ORTHOPAEDIC SURGERY TREPHINES, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OR-088-25</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-19T05:46:33.562Z</lastUpdated>
  </row>
  <row>
    <udiDi>05055445937379</udiDi>
    <basicUdiDi>50554459CUTTINGINSTRL2</basicUdiDi>
    <tradeName>Borchardt Oval, Coarse Spacing Ø 13.0 mm  Stainless Steel</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Surtex Instruments Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000023183</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>L090902</emdnCode>
    <emdnDescription>ORTHOPAEDIC SURGERY TREPHINES, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OR-086-13</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-19T05:46:32.665Z</lastUpdated>
  </row>
  <row>
    <udiDi>05055445937362</udiDi>
    <basicUdiDi>50554459CUTTINGINSTRL2</basicUdiDi>
    <tradeName>Albee Pointed Cutter Ø 7.0 mm Stainless Steel</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Surtex Instruments Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000023183</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>L090902</emdnCode>
    <emdnDescription>ORTHOPAEDIC SURGERY TREPHINES, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OR-084-07</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-19T05:46:31.763Z</lastUpdated>
  </row>
  <row>
    <udiDi>05055445937355</udiDi>
    <basicUdiDi>50554459CUTTINGINSTRL2</basicUdiDi>
    <tradeName>Albee Oval, Coarse Spacing Ø 12.0 mm Stainless Steel</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Surtex Instruments Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000023183</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>L090902</emdnCode>
    <emdnDescription>ORTHOPAEDIC SURGERY TREPHINES, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OR-082-12</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-19T05:46:30.887Z</lastUpdated>
  </row>
  <row>
    <udiDi>05055445937348</udiDi>
    <basicUdiDi>50554459CUTTINGINSTRL2</basicUdiDi>
    <tradeName>Albee Oval, Coarse Spacing Ø 10.0 mm Stainless Steel</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Surtex Instruments Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000023183</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>L090902</emdnCode>
    <emdnDescription>ORTHOPAEDIC SURGERY TREPHINES, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OR-082-10</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-19T05:46:29.959Z</lastUpdated>
  </row>
  <row>
    <udiDi>05055445937331</udiDi>
    <basicUdiDi>50554459CUTTINGINSTRL2</basicUdiDi>
    <tradeName>Albee Oval, Coarse Spacing Ø 8.0 mm Stainless Steel</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Surtex Instruments Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000023183</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>L090902</emdnCode>
    <emdnDescription>ORTHOPAEDIC SURGERY TREPHINES, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OR-082-08</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-19T05:46:29.062Z</lastUpdated>
  </row>
</eudamedExport>