<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>G500A172030350</udiDi>
    <basicUdiDi>B-G500A172030350</basicUdiDi>
    <tradeName>Sorath Ortho, Sorath</tradeName>
    <deviceName>Cancellous Bone Screw, Dia. 4.0 mm x short thread, Torx, 35 mm, SS316LVM</deviceName>
    <manufacturerName>Sigma Surgical Private Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000013665</manufacturerSrn>
    <authorisedRepresentativeName>Amstermed B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001971</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P09120699</emdnCode>
    <emdnDescription>BONE FIXATION SCREWS, TENDON AND LIGAMENT SYNTHESIS SCREWS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A17203035</reference>
    <placedOnMarketCountry>Bulgaria</placedOnMarketCountry>
    <lastUpdated>2026-07-13T20:56:49.168Z</lastUpdated>
  </row>
  <row>
    <udiDi>G500A172030340</udiDi>
    <basicUdiDi>B-G500A172030340</basicUdiDi>
    <tradeName>Sorath Ortho, Sorath</tradeName>
    <deviceName>Cancellous Bone Screw, Dia. 4.0 mm x short thread, Torx, 34 mm, SS316LVM</deviceName>
    <manufacturerName>Sigma Surgical Private Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000013665</manufacturerSrn>
    <authorisedRepresentativeName>Amstermed B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001971</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P09120699</emdnCode>
    <emdnDescription>BONE FIXATION SCREWS, TENDON AND LIGAMENT SYNTHESIS SCREWS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A17203034</reference>
    <placedOnMarketCountry>Bulgaria</placedOnMarketCountry>
    <lastUpdated>2026-07-13T20:56:47.565Z</lastUpdated>
  </row>
  <row>
    <udiDi>G500A172030320</udiDi>
    <basicUdiDi>B-G500A172030320</basicUdiDi>
    <tradeName>Sorath Ortho, Sorath</tradeName>
    <deviceName>Cancellous Bone Screw, Dia. 4.0 mm x short thread, Torx, 32 mm, SS316LVM</deviceName>
    <manufacturerName>Sigma Surgical Private Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000013665</manufacturerSrn>
    <authorisedRepresentativeName>Amstermed B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001971</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P09120699</emdnCode>
    <emdnDescription>BONE FIXATION SCREWS, TENDON AND LIGAMENT SYNTHESIS SCREWS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A17203032</reference>
    <placedOnMarketCountry>Bulgaria</placedOnMarketCountry>
    <lastUpdated>2026-07-13T20:56:45.170Z</lastUpdated>
  </row>
  <row>
    <udiDi>G500A172030300</udiDi>
    <basicUdiDi>B-G500A172030300</basicUdiDi>
    <tradeName>Sorath Ortho, Sorath</tradeName>
    <deviceName>Cancellous Bone Screw, Dia. 4.0 mm x short thread, Torx, 30 mm, SS316LVM</deviceName>
    <manufacturerName>Sigma Surgical Private Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000013665</manufacturerSrn>
    <authorisedRepresentativeName>Amstermed B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001971</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P09120699</emdnCode>
    <emdnDescription>BONE FIXATION SCREWS, TENDON AND LIGAMENT SYNTHESIS SCREWS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A17203030</reference>
    <placedOnMarketCountry>Bulgaria</placedOnMarketCountry>
    <lastUpdated>2026-07-13T20:56:43.670Z</lastUpdated>
  </row>
  <row>
    <udiDi>G500A172030280</udiDi>
    <basicUdiDi>B-G500A172030280</basicUdiDi>
    <tradeName>Sorath Ortho, Sorath</tradeName>
    <deviceName>Cancellous Bone Screw, Dia. 4.0 mm x short thread, Torx, 28 mm, SS316LVM</deviceName>
    <manufacturerName>Sigma Surgical Private Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000013665</manufacturerSrn>
    <authorisedRepresentativeName>Amstermed B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001971</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P09120699</emdnCode>
    <emdnDescription>BONE FIXATION SCREWS, TENDON AND LIGAMENT SYNTHESIS SCREWS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A17203028</reference>
    <placedOnMarketCountry>Bulgaria</placedOnMarketCountry>
    <lastUpdated>2026-07-13T20:56:41.967Z</lastUpdated>
  </row>
  <row>
    <udiDi>G500A172030260</udiDi>
    <basicUdiDi>B-G500A172030260</basicUdiDi>
    <tradeName>Sorath Ortho, Sorath</tradeName>
    <deviceName>Cancellous Bone Screw, Dia. 4.0 mm x short thread, Torx, 26 mm, SS316LVM</deviceName>
    <manufacturerName>Sigma Surgical Private Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000013665</manufacturerSrn>
    <authorisedRepresentativeName>Amstermed B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001971</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P09120699</emdnCode>
    <emdnDescription>BONE FIXATION SCREWS, TENDON AND LIGAMENT SYNTHESIS SCREWS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A17203026</reference>
    <placedOnMarketCountry>Bulgaria</placedOnMarketCountry>
    <lastUpdated>2026-07-13T20:56:40.365Z</lastUpdated>
  </row>
  <row>
    <udiDi>G500A172030240</udiDi>
    <basicUdiDi>B-G500A172030240</basicUdiDi>
    <tradeName>Sorath Ortho, Sorath</tradeName>
    <deviceName>Cancellous Bone Screw, Dia. 4.0 mm x short thread, Torx, 24 mm, SS316LVM</deviceName>
    <manufacturerName>Sigma Surgical Private Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000013665</manufacturerSrn>
    <authorisedRepresentativeName>Amstermed B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001971</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P09120699</emdnCode>
    <emdnDescription>BONE FIXATION SCREWS, TENDON AND LIGAMENT SYNTHESIS SCREWS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A17203024</reference>
    <placedOnMarketCountry>Bulgaria</placedOnMarketCountry>
    <lastUpdated>2026-07-13T20:56:37.956Z</lastUpdated>
  </row>
  <row>
    <udiDi>G500A172030220</udiDi>
    <basicUdiDi>B-G500A172030220</basicUdiDi>
    <tradeName>Sorath Ortho, Sorath</tradeName>
    <deviceName>Cancellous Bone Screw, Dia. 4.0 mm x short thread, Torx, 22 mm, SS316LVM</deviceName>
    <manufacturerName>Sigma Surgical Private Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000013665</manufacturerSrn>
    <authorisedRepresentativeName>Amstermed B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001971</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P09120699</emdnCode>
    <emdnDescription>BONE FIXATION SCREWS, TENDON AND LIGAMENT SYNTHESIS SCREWS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A17203022</reference>
    <placedOnMarketCountry>Bulgaria</placedOnMarketCountry>
    <lastUpdated>2026-07-13T20:56:37.194Z</lastUpdated>
  </row>
  <row>
    <udiDi>G500A172030200</udiDi>
    <basicUdiDi>B-G500A172030200</basicUdiDi>
    <tradeName>Sorath Ortho, Sorath</tradeName>
    <deviceName>Cancellous Bone Screw, Dia. 4.0 mm x short thread, Torx, 20 mm, SS316LVM</deviceName>
    <manufacturerName>Sigma Surgical Private Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000013665</manufacturerSrn>
    <authorisedRepresentativeName>Amstermed B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001971</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P09120699</emdnCode>
    <emdnDescription>BONE FIXATION SCREWS, TENDON AND LIGAMENT SYNTHESIS SCREWS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A17203020</reference>
    <placedOnMarketCountry>Bulgaria</placedOnMarketCountry>
    <lastUpdated>2026-07-13T20:56:37.095Z</lastUpdated>
  </row>
  <row>
    <udiDi>G500A172030180</udiDi>
    <basicUdiDi>B-G500A172030180</basicUdiDi>
    <tradeName>Sorath Ortho, Sorath</tradeName>
    <deviceName>Cancellous Bone Screw, Dia. 4.0 mm x short thread, Torx, 18 mm, SS316LVM</deviceName>
    <manufacturerName>Sigma Surgical Private Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000013665</manufacturerSrn>
    <authorisedRepresentativeName>Amstermed B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001971</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P09120699</emdnCode>
    <emdnDescription>BONE FIXATION SCREWS, TENDON AND LIGAMENT SYNTHESIS SCREWS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A17203018</reference>
    <placedOnMarketCountry>Bulgaria</placedOnMarketCountry>
    <lastUpdated>2026-07-13T20:56:34.023Z</lastUpdated>
  </row>
  <row>
    <udiDi>G500A172030160</udiDi>
    <basicUdiDi>B-G500A172030160</basicUdiDi>
    <tradeName>Sorath Ortho, Sorath</tradeName>
    <deviceName>Cancellous Bone Screw, Dia. 4.0 mm x short thread, Torx, 16 mm, SS316LVM</deviceName>
    <manufacturerName>Sigma Surgical Private Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000013665</manufacturerSrn>
    <authorisedRepresentativeName>Amstermed B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001971</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P09120699</emdnCode>
    <emdnDescription>BONE FIXATION SCREWS, TENDON AND LIGAMENT SYNTHESIS SCREWS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A17203016</reference>
    <placedOnMarketCountry>Bulgaria</placedOnMarketCountry>
    <lastUpdated>2026-07-13T20:56:31.164Z</lastUpdated>
  </row>
  <row>
    <udiDi>G500A172030140</udiDi>
    <basicUdiDi>B-G500A172030140</basicUdiDi>
    <tradeName>Sorath Ortho, Sorath</tradeName>
    <deviceName>Cancellous Bone Screw, Dia. 4.0 mm x short thread, Torx, 14 mm, SS316LVM</deviceName>
    <manufacturerName>Sigma Surgical Private Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000013665</manufacturerSrn>
    <authorisedRepresentativeName>Amstermed B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001971</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P09120699</emdnCode>
    <emdnDescription>BONE FIXATION SCREWS, TENDON AND LIGAMENT SYNTHESIS SCREWS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A17203014</reference>
    <placedOnMarketCountry>Bulgaria</placedOnMarketCountry>
    <lastUpdated>2026-07-13T20:56:29.159Z</lastUpdated>
  </row>
  <row>
    <udiDi>G500A172030120</udiDi>
    <basicUdiDi>B-G500A172030120</basicUdiDi>
    <tradeName>Sorath Ortho, Sorath</tradeName>
    <deviceName>Cancellous Bone Screw, Dia. 4.0 mm x short thread, Torx, 12 mm, SS316LVM</deviceName>
    <manufacturerName>Sigma Surgical Private Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000013665</manufacturerSrn>
    <authorisedRepresentativeName>Amstermed B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001971</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P09120699</emdnCode>
    <emdnDescription>BONE FIXATION SCREWS, TENDON AND LIGAMENT SYNTHESIS SCREWS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A17203012</reference>
    <placedOnMarketCountry>Bulgaria</placedOnMarketCountry>
    <lastUpdated>2026-07-13T20:56:28.356Z</lastUpdated>
  </row>
  <row>
    <udiDi>G500A172030100</udiDi>
    <basicUdiDi>B-G500A172030100</basicUdiDi>
    <tradeName>Sorath Ortho, Sorath</tradeName>
    <deviceName>Cancellous Bone Screw, Dia. 4.0 mm x short thread, Torx, 10 mm, SS316LVM</deviceName>
    <manufacturerName>Sigma Surgical Private Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000013665</manufacturerSrn>
    <authorisedRepresentativeName>Amstermed B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001971</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P09120699</emdnCode>
    <emdnDescription>BONE FIXATION SCREWS, TENDON AND LIGAMENT SYNTHESIS SCREWS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A17203010</reference>
    <placedOnMarketCountry>Bulgaria</placedOnMarketCountry>
    <lastUpdated>2026-07-13T20:56:26.758Z</lastUpdated>
  </row>
  <row>
    <udiDi>G500A172010800</udiDi>
    <basicUdiDi>B-G500A172010800</basicUdiDi>
    <tradeName>Sorath Ortho, Sorath</tradeName>
    <deviceName>Cancellous Bone Screw, Dia. 4.0 mm x short thread, Torx, 80 mm, SS316L</deviceName>
    <manufacturerName>Sigma Surgical Private Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000013665</manufacturerSrn>
    <authorisedRepresentativeName>Amstermed B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001971</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P09120699</emdnCode>
    <emdnDescription>BONE FIXATION SCREWS, TENDON AND LIGAMENT SYNTHESIS SCREWS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A17201080</reference>
    <placedOnMarketCountry>Bulgaria</placedOnMarketCountry>
    <lastUpdated>2026-07-13T20:56:24.359Z</lastUpdated>
  </row>
  <row>
    <udiDi>G500A172010750</udiDi>
    <basicUdiDi>B-G500A172010750</basicUdiDi>
    <tradeName>Sorath Ortho, Sorath</tradeName>
    <deviceName>Cancellous Bone Screw, Dia. 4.0 mm x short thread, Torx, 75 mm, SS316L</deviceName>
    <manufacturerName>Sigma Surgical Private Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000013665</manufacturerSrn>
    <authorisedRepresentativeName>Amstermed B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001971</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P09120699</emdnCode>
    <emdnDescription>BONE FIXATION SCREWS, TENDON AND LIGAMENT SYNTHESIS SCREWS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A17201075</reference>
    <placedOnMarketCountry>Bulgaria</placedOnMarketCountry>
    <lastUpdated>2026-07-13T20:56:22.756Z</lastUpdated>
  </row>
  <row>
    <udiDi>G500A172010700</udiDi>
    <basicUdiDi>B-G500A172010700</basicUdiDi>
    <tradeName>Sorath Ortho, Sorath</tradeName>
    <deviceName>Cancellous Bone Screw, Dia. 4.0 mm x short thread, Torx, 70 mm, SS316L</deviceName>
    <manufacturerName>Sigma Surgical Private Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000013665</manufacturerSrn>
    <authorisedRepresentativeName>Amstermed B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001971</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P09120699</emdnCode>
    <emdnDescription>BONE FIXATION SCREWS, TENDON AND LIGAMENT SYNTHESIS SCREWS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A17201070</reference>
    <placedOnMarketCountry>Bulgaria</placedOnMarketCountry>
    <lastUpdated>2026-07-13T20:56:21.962Z</lastUpdated>
  </row>
  <row>
    <udiDi>G500A172010650</udiDi>
    <basicUdiDi>B-G500A172010650</basicUdiDi>
    <tradeName>Sorath Ortho, Sorath</tradeName>
    <deviceName>Cancellous Bone Screw, Dia. 4.0 mm x short thread, Torx, 65 mm, SS316L</deviceName>
    <manufacturerName>Sigma Surgical Private Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000013665</manufacturerSrn>
    <authorisedRepresentativeName>Amstermed B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001971</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P09120699</emdnCode>
    <emdnDescription>BONE FIXATION SCREWS, TENDON AND LIGAMENT SYNTHESIS SCREWS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A17201065</reference>
    <placedOnMarketCountry>Bulgaria</placedOnMarketCountry>
    <lastUpdated>2026-07-13T20:56:19.554Z</lastUpdated>
  </row>
  <row>
    <udiDi>G500A172010600</udiDi>
    <basicUdiDi>B-G500A172010600</basicUdiDi>
    <tradeName>Sorath Ortho, Sorath</tradeName>
    <deviceName>Cancellous Bone Screw, Dia. 4.0 mm x short thread, Torx, 60 mm, SS316L</deviceName>
    <manufacturerName>Sigma Surgical Private Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000013665</manufacturerSrn>
    <authorisedRepresentativeName>Amstermed B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001971</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P09120699</emdnCode>
    <emdnDescription>BONE FIXATION SCREWS, TENDON AND LIGAMENT SYNTHESIS SCREWS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A17201060</reference>
    <placedOnMarketCountry>Bulgaria</placedOnMarketCountry>
    <lastUpdated>2026-07-13T20:56:17.147Z</lastUpdated>
  </row>
  <row>
    <udiDi>G500A172010550</udiDi>
    <basicUdiDi>B-G500A172010550</basicUdiDi>
    <tradeName>Sorath Ortho, Sorath</tradeName>
    <deviceName>Cancellous Bone Screw, Dia. 4.0 mm x short thread, Torx, 55 mm, SS316L</deviceName>
    <manufacturerName>Sigma Surgical Private Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000013665</manufacturerSrn>
    <authorisedRepresentativeName>Amstermed B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001971</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>P09120699</emdnCode>
    <emdnDescription>BONE FIXATION SCREWS, TENDON AND LIGAMENT SYNTHESIS SCREWS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A17201055</reference>
    <placedOnMarketCountry>Bulgaria</placedOnMarketCountry>
    <lastUpdated>2026-07-13T20:56:15.539Z</lastUpdated>
  </row>
</eudamedExport>