<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>90012345000020</udiDi>
    <basicUdiDi>90012345LowVisionCP</basicUdiDi>
    <tradeName>EyeT – Illuminated Glasses for Low Vision</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Low Vision Center</manufacturerName>
    <manufacturerSrn>IL-MF-000051366</manufacturerSrn>
    <authorisedRepresentativeName>AF Pharma Service Europe SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000018076</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q02100202</emdnCode>
    <emdnDescription>PLASTIC SPECTACLE FRAMES WITHOUT LENSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EyeT-2</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T00:30:16.964Z</lastUpdated>
  </row>
  <row>
    <udiDi>B359OAIIV11</udiDi>
    <basicUdiDi>B-B359OAIIV11</basicUdiDi>
    <tradeName>B359OAIIV11</tradeName>
    <deviceName></deviceName>
    <manufacturerName>RamSoft Inc.</manufacturerName>
    <manufacturerSrn>CA-MF-000038450</manufacturerSrn>
    <authorisedRepresentativeName>AF Pharma Service Europe SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000018076</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OAIIV1</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T00:28:48.878Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-0880123450002SY</udiDi>
    <basicUdiDi>B-0880123450002SY</basicUdiDi>
    <tradeName>Dental Zirconia Material</tradeName>
    <deviceName></deviceName>
    <manufacturerName>DentMedi Co., Ltd</manufacturerName>
    <manufacturerSrn>KR-MF-000032822</manufacturerSrn>
    <authorisedRepresentativeName>AF Pharma Service Europe SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000018076</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BCM-W1000</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:46:40.906Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-Gateway-MAMMOR2</udiDi>
    <basicUdiDi>B-Gateway-MAMMOR2</basicUdiDi>
    <tradeName>D-Gateway-MAMMOR2</tradeName>
    <deviceName></deviceName>
    <manufacturerName>RamSoft Inc.</manufacturerName>
    <manufacturerSrn>CA-MF-000038450</manufacturerSrn>
    <authorisedRepresentativeName>AF Pharma Service Europe SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000018076</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MAMMO</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:00:59.231Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-Gateway-QC38</udiDi>
    <basicUdiDi>B-Gateway-QC38</basicUdiDi>
    <tradeName>D-Gateway-QC38</tradeName>
    <deviceName></deviceName>
    <manufacturerName>RamSoft Inc.</manufacturerName>
    <manufacturerSrn>CA-MF-000038450</manufacturerSrn>
    <authorisedRepresentativeName>AF Pharma Service Europe SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000018076</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>QC</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:00:59.196Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-Gateway-ROUTER8G</udiDi>
    <basicUdiDi>B-Gateway-ROUTER8G</basicUdiDi>
    <tradeName>D-Gateway-ROUTER8G</tradeName>
    <deviceName></deviceName>
    <manufacturerName>RamSoft Inc.</manufacturerName>
    <manufacturerSrn>CA-MF-000038450</manufacturerSrn>
    <authorisedRepresentativeName>AF Pharma Service Europe SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000018076</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ROUTER</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:00:59.153Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-HeartView-12iZM</udiDi>
    <basicUdiDi>B-HeartView-12iZM</basicUdiDi>
    <tradeName>D-HeartView-12iZM</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Aerotel Medical Systems (1998) Ltd.</manufacturerName>
    <manufacturerSrn>IL-MF-000038449</manufacturerSrn>
    <authorisedRepresentativeName>AF Pharma Service Europe SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000018076</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>12i</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:00:05.536Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-HeartView-12LY5</udiDi>
    <basicUdiDi>B-HeartView-12LY5</basicUdiDi>
    <tradeName>D-HeartView-12LY5</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Aerotel Medical Systems (1998) Ltd.</manufacturerName>
    <manufacturerSrn>IL-MF-000038449</manufacturerSrn>
    <authorisedRepresentativeName>AF Pharma Service Europe SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000018076</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>12L</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:00:05.520Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-HeartView-P12/8i26</udiDi>
    <basicUdiDi>B-HeartView-P12/8i26</basicUdiDi>
    <tradeName>D-HeartView-P12/8i26</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Aerotel Medical Systems (1998) Ltd.</manufacturerName>
    <manufacturerSrn>IL-MF-000038449</manufacturerSrn>
    <authorisedRepresentativeName>AF Pharma Service Europe SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000018076</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P12/8i</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:00:05.493Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-HeartView-P12/8MobileMS</udiDi>
    <basicUdiDi>B-HeartView-P12/8MobileMS</basicUdiDi>
    <tradeName>D-HeartView-P12/8MobileMS</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Aerotel Medical Systems (1998) Ltd.</manufacturerName>
    <manufacturerSrn>IL-MF-000038449</manufacturerSrn>
    <authorisedRepresentativeName>AF Pharma Service Europe SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000018076</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P12/8 Mobile</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T23:00:05.456Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-JMBIOTECHNeedlsUM</udiDi>
    <basicUdiDi>B-JMBIOTECHNeedlsUM</basicUdiDi>
    <tradeName>TURTLEPIN III-0.5(4)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>JMBIOTECH</manufacturerName>
    <manufacturerSrn>KR-MF-000029867</manufacturerSrn>
    <authorisedRepresentativeName>AF Pharma Service Europe SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000018076</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>NEEDLES FOR INFUSION AND COLLECTION - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TURTLEPIN III-0.5(4)</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:58:54.357Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-PowerServer-LITEPACS3U</udiDi>
    <basicUdiDi>B-PowerServer-LITEPACS3U</basicUdiDi>
    <tradeName>D-PowerServer-LITEPACS3U</tradeName>
    <deviceName></deviceName>
    <manufacturerName>RamSoft Inc.</manufacturerName>
    <manufacturerSrn>CA-MF-000038450</manufacturerSrn>
    <authorisedRepresentativeName>AF Pharma Service Europe SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000018076</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LITE PACS</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:56:34.242Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-PowerServer-PACSQX</udiDi>
    <basicUdiDi>B-PowerServer-PACSQX</basicUdiDi>
    <tradeName>D-PowerServer-PACSQX</tradeName>
    <deviceName></deviceName>
    <manufacturerName>RamSoft Inc.</manufacturerName>
    <manufacturerSrn>CA-MF-000038450</manufacturerSrn>
    <authorisedRepresentativeName>AF Pharma Service Europe SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000018076</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PACS</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:56:34.224Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-PowerServer-RIS/PACSXP</udiDi>
    <basicUdiDi>B-PowerServer-RIS/PACSXP</basicUdiDi>
    <tradeName>D-PowerServer-RIS/PACSXP</tradeName>
    <deviceName></deviceName>
    <manufacturerName>RamSoft Inc.</manufacturerName>
    <manufacturerSrn>CA-MF-000038450</manufacturerSrn>
    <authorisedRepresentativeName>AF Pharma Service Europe SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000018076</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RIS/ PACS</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:56:34.205Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-PowerServer-RISPACSMU2L</udiDi>
    <basicUdiDi>B-PowerServer-RISPACSMU2L</basicUdiDi>
    <tradeName>D-PowerServer-RISPACSMU2L</tradeName>
    <deviceName></deviceName>
    <manufacturerName>RamSoft Inc.</manufacturerName>
    <manufacturerSrn>CA-MF-000038450</manufacturerSrn>
    <authorisedRepresentativeName>AF Pharma Service Europe SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000018076</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RIS/PACS MU</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:56:34.185Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-PowerServer-TELELITE4B</udiDi>
    <basicUdiDi>B-PowerServer-TELELITE4B</basicUdiDi>
    <tradeName>D-PowerServer-TELELITE4B</tradeName>
    <deviceName></deviceName>
    <manufacturerName>RamSoft Inc.</manufacturerName>
    <manufacturerSrn>CA-MF-000038450</manufacturerSrn>
    <authorisedRepresentativeName>AF Pharma Service Europe SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000018076</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TELE LITE</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:56:34.165Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-PowerServer-TELEPLUS6M</udiDi>
    <basicUdiDi>B-PowerServer-TELEPLUS6M</basicUdiDi>
    <tradeName>D-PowerServer-TELEPLUS6M</tradeName>
    <deviceName></deviceName>
    <manufacturerName>RamSoft Inc.</manufacturerName>
    <manufacturerSrn>CA-MF-000038450</manufacturerSrn>
    <authorisedRepresentativeName>AF Pharma Service Europe SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000018076</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TELE PLUS</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:56:34.142Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-PowerServer-XUPACSQX</udiDi>
    <basicUdiDi>B-PowerServer-XUPACSQX</basicUdiDi>
    <tradeName>D-PowerServer-XUPACSQX</tradeName>
    <deviceName></deviceName>
    <manufacturerName>RamSoft Inc.</manufacturerName>
    <manufacturerSrn>CA-MF-000038450</manufacturerSrn>
    <authorisedRepresentativeName>AF Pharma Service Europe SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000018076</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>XUPACS</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:56:34.122Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-RHSFJ</udiDi>
    <basicUdiDi>B-RHSFJ</basicUdiDi>
    <tradeName>D-RHSFJ</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Aerotel Medical Systems (1998) Ltd.</manufacturerName>
    <manufacturerSrn>IL-MF-000038449</manufacturerSrn>
    <authorisedRepresentativeName>AF Pharma Service Europe SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000018076</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>-</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:56:31.546Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810114911136</udiDi>
    <basicUdiDi>081011491Magnification6C</basicUdiDi>
    <tradeName>SurgiTel</tradeName>
    <deviceName></deviceName>
    <manufacturerName>General Scientific Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000038902</manufacturerSrn>
    <authorisedRepresentativeName>AF Pharma Service Europe SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000018076</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Y210399</emdnCode>
    <emdnDescription>OPTICAL AIDS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-06T10:38:01.135Z</lastUpdated>
  </row>
</eudamedExport>