<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>00813787020419</udiDi>
    <basicUdiDi>B-00813787020419</basicUdiDi>
    <tradeName>AgX100® I125 Implants: TheraSleeve® up to 12 seeds - STERILE</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Theragenics Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000003014</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>AIMDD</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>XX92xi, XX92xiS</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-22T03:10:43.079Z</lastUpdated>
  </row>
  <row>
    <udiDi>00813787022178</udiDi>
    <basicUdiDi>B-00813787022178</basicUdiDi>
    <tradeName>Applicator Stylets for IsoLoader Transfer Tubes, 5 Pack</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Theragenics Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000003014</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>AIMDD</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TG3088</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-22T00:26:40.311Z</lastUpdated>
  </row>
  <row>
    <udiDi>00813787021263</udiDi>
    <basicUdiDi>B-00813787021263</basicUdiDi>
    <tradeName>Prostate Seeding Needle "SeedLock Pre-Plugged, Box 50 -STERILE</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Theragenics Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000003014</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>AIMDD</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PSS1820SL3</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-22T00:24:52.815Z</lastUpdated>
  </row>
  <row>
    <udiDi>00813787021270</udiDi>
    <basicUdiDi>B-00813787021270</basicUdiDi>
    <tradeName>Prostate Seeding Needle "SeedLock Pre-Plugged", 5-pack - STERILE</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Theragenics Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000003014</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>AIMDD</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PSS1820SL3-5</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-22T00:24:52.549Z</lastUpdated>
  </row>
  <row>
    <udiDi>00813787021287</udiDi>
    <basicUdiDi>B-00813787021287</basicUdiDi>
    <tradeName>Prostate Seeding Needle "SeedLock Pre-Plugged", 1-pack</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Theragenics Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000003014</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>AIMDD</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PSS1820SL3-1</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-22T00:24:42.872Z</lastUpdated>
  </row>
  <row>
    <udiDi>00813787021294</udiDi>
    <basicUdiDi>B-00813787021294</basicUdiDi>
    <tradeName>Prostate Seeding Ndl 1pk Pink EZ (NO PLUG)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Theragenics Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000003014</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>AIMDD</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PSS1820EZ-1</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-22T00:24:42.182Z</lastUpdated>
  </row>
  <row>
    <udiDi>00813787021409</udiDi>
    <basicUdiDi>B-00813787021409</basicUdiDi>
    <tradeName>18g Square Hub Brachytherapy Needle, Sterile, Pre-waxed, Box of 25</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Theragenics Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000003014</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>AIMDD</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CPPS-SQ-1820X</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-22T00:11:44.221Z</lastUpdated>
  </row>
  <row>
    <udiDi>00813787021416</udiDi>
    <basicUdiDi>B-00813787021416</basicUdiDi>
    <tradeName>18g Square Hub Brachytherapy Needle, Sterile, Pre-waxed, 5 pack</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Theragenics Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000003014</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>AIMDD</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CPPS-SQ-1820X-5</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-22T00:11:43.085Z</lastUpdated>
  </row>
  <row>
    <udiDi>00813787021423</udiDi>
    <basicUdiDi>B-00813787021423</basicUdiDi>
    <tradeName>18g Square Hub Brachytherapy Needle, Sterile, Pre-waxed, 1 pack</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Theragenics Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000003014</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>AIMDD</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CPPS-SQ-1820X-1</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-22T00:11:42.793Z</lastUpdated>
  </row>
  <row>
    <udiDi>00813787020037</udiDi>
    <basicUdiDi>B-00813787020037</basicUdiDi>
    <tradeName>AgX100 (I-125)</tradeName>
    <deviceName>AgX100 I-125 Implants, Loose and Magazine Loaded Seeds</deviceName>
    <manufacturerName>Theragenics Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000003014</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>AIMDD</riskClass>
    <legislation>AIMDD</legislation>
    <emdnCode>J0501</emdnCode>
    <emdnDescription>BRACHYTHERAPY SOURCES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>XX500i</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-08-13T07:26:03.311Z</lastUpdated>
  </row>
  <row>
    <udiDi>00813787020174</udiDi>
    <basicUdiDi>B-00813787020174</basicUdiDi>
    <tradeName>AgX100® I125 Implants, Loose and Magazine Loaded Seeds</tradeName>
    <deviceName>AgX100® I125 Implants, Loose and Magazine Loaded Seeds</deviceName>
    <manufacturerName>Theragenics Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000003014</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>J0501</emdnCode>
    <emdnDescription>BRACHYTHERAPY SOURCES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>XX6510iN, XX6515iN or XX6520iN</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-08-06T03:59:11.263Z</lastUpdated>
  </row>
  <row>
    <udiDi>00813787022147</udiDi>
    <basicUdiDi>B-00813787022147</basicUdiDi>
    <tradeName>AgX100® I125 Implants, Loose and Magazine Loaded Seeds</tradeName>
    <deviceName>AgX100® I125 Implants, Loose and Magazine Loaded Seeds</deviceName>
    <manufacturerName>Theragenics Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000003014</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>J0501</emdnCode>
    <emdnDescription>BRACHYTHERAPY SOURCES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>XX6510iN, XX6515iN or XX6520iN</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-08-05T14:08:26.398Z</lastUpdated>
  </row>
  <row>
    <udiDi>00813787020167</udiDi>
    <basicUdiDi>B-00813787020167</basicUdiDi>
    <tradeName>AgX100® I125 Implants, Loose and Magazine Loaded Seeds</tradeName>
    <deviceName>AgX100® I125 Implants, Loose and Magazine Loaded Seeds</deviceName>
    <manufacturerName>Theragenics Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000003014</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>J0501</emdnCode>
    <emdnDescription>BRACHYTHERAPY SOURCES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>XX6510i, XX6515i or XX6520i</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-08-05T14:08:24.821Z</lastUpdated>
  </row>
  <row>
    <udiDi>00813787020143</udiDi>
    <basicUdiDi>B-00813787020143</basicUdiDi>
    <tradeName>AgX100® I125 Implants</tradeName>
    <deviceName>AgX100® I125 Implants</deviceName>
    <manufacturerName>Theragenics Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000003014</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>J0501</emdnCode>
    <emdnDescription>BRACHYTHERAPY SOURCES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>XX65XXiX orXX650Xi</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-08-05T14:08:22.419Z</lastUpdated>
  </row>
  <row>
    <udiDi>00813787020099</udiDi>
    <basicUdiDi>B-00813787020099</basicUdiDi>
    <tradeName>AgX100® I125 Implants, Loose and Magazine Loaded Seeds</tradeName>
    <deviceName>AgX100® I125 Implants, Loose and Magazine Loaded Seeds</deviceName>
    <manufacturerName>Theragenics Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000003014</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>J0501</emdnCode>
    <emdnDescription>BRACHYTHERAPY SOURCES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>XX509iN</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-08-05T14:08:20.821Z</lastUpdated>
  </row>
  <row>
    <udiDi>00813787020082</udiDi>
    <basicUdiDi>B-00813787020082</basicUdiDi>
    <tradeName>AgX100® I125 Implants, Loose and Magazine Loaded Seeds</tradeName>
    <deviceName>AgX100® I125 Implants, Loose and Magazine Loaded Seeds</deviceName>
    <manufacturerName>Theragenics Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000003014</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>J0501</emdnCode>
    <emdnDescription>BRACHYTHERAPY SOURCES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>XX508i</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-08-05T14:08:20.004Z</lastUpdated>
  </row>
  <row>
    <udiDi>00813787020068</udiDi>
    <basicUdiDi>B-00813787020068</basicUdiDi>
    <tradeName>AgX100® I125 Implants, Non-Prostate Implants</tradeName>
    <deviceName>AgX100® I125 Implants, Non-Prostate Implants</deviceName>
    <manufacturerName>Theragenics Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000003014</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>AIMDD</riskClass>
    <legislation>AIMDD</legislation>
    <emdnCode>J0501</emdnCode>
    <emdnDescription>BRACHYTHERAPY SOURCES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>XX607i</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-08-05T14:08:18.427Z</lastUpdated>
  </row>
  <row>
    <udiDi>00813787020020</udiDi>
    <basicUdiDi>B-00813787020020</basicUdiDi>
    <tradeName>AgX100® I125 Implants</tradeName>
    <deviceName>AgX100® I125 Implants, Loose and Magazine Loaded Seeds</deviceName>
    <manufacturerName>Theragenics Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000003014</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>AIMDD</riskClass>
    <legislation>AIMDD</legislation>
    <emdnCode>J0502</emdnCode>
    <emdnDescription>BRACHYTHERAPY ADMINISTRATION KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>XX502iNS</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-08-04T22:15:42.385Z</lastUpdated>
  </row>
  <row>
    <udiDi>00813787020013</udiDi>
    <basicUdiDi>B-00813787020013</basicUdiDi>
    <tradeName>TheraSeed</tradeName>
    <deviceName>TheraSeed® Pd-103 Implants: Loose seeds in a vial - STERILE</deviceName>
    <manufacturerName>Theragenics Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000003014</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>AIMDD</riskClass>
    <legislation>AIMDD</legislation>
    <emdnCode>J0501</emdnCode>
    <emdnDescription>BRACHYTHERAPY SOURCES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>XX500</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-29T20:12:40.875Z</lastUpdated>
  </row>
  <row>
    <udiDi>00813787022369</udiDi>
    <basicUdiDi>B-00813787022369</basicUdiDi>
    <tradeName>Manual IsoLoader 2.0</tradeName>
    <deviceName>Manual IsoLoader 2.0</deviceName>
    <manufacturerName>Theragenics Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000003014</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>J0580</emdnCode>
    <emdnDescription>IMPLANTABLE BRACHYTHERAPY DEVICES - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MIL2-700345</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-29T07:24:43.890Z</lastUpdated>
  </row>
</eudamedExport>