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<eudamedExport entity="devices">
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    <udiDi>07640187915655</udiDi>
    <basicUdiDi>764018791REAMACETAB01SP</basicUdiDi>
    <tradeName>Acetabular reamer Ø80 with round tooth</tradeName>
    <deviceName></deviceName>
    <manufacturerName>MPS Micro Precision Systems AG</manufacturerName>
    <manufacturerSrn>CH-MF-000032439</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>T16231</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-08T19:45:33.379Z</lastUpdated>
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  <row>
    <udiDi>00686597200414</udiDi>
    <basicUdiDi>B-00686597200414</basicUdiDi>
    <tradeName>INSTI HIV-1/HIV-2 ANTIBODY TEST</tradeName>
    <deviceName></deviceName>
    <manufacturerName>bioLytical Laboratories Inc.</manufacturerName>
    <manufacturerSrn>CA-MF-000023304</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>HIV MULTIPLE ANTIBODY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>90-1015-010</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-08T19:45:33.332Z</lastUpdated>
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  <row>
    <udiDi>00686597202173</udiDi>
    <basicUdiDi>B-00686597202173</basicUdiDi>
    <tradeName>INSTI HIV-1/HIV-2 ANTIBODY TEST</tradeName>
    <deviceName></deviceName>
    <manufacturerName>bioLytical Laboratories Inc.</manufacturerName>
    <manufacturerSrn>CA-MF-000023304</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>HIV MULTIPLE ANTIBODY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>90-1015-017 and 90-1015-018</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-08T19:45:33.166Z</lastUpdated>
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    <udiDi>20859760005015</udiDi>
    <basicUdiDi>0859760005PMV005AN</basicUdiDi>
    <tradeName>PASSY-MUIR™ TRACHEOSTOMY &amp; VENTILATOR SWALLOWING AND SPEAKING VALVE PMV™ 005 (white)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Passy-Muir, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000002288</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>PHONATION VALVES FOR TRACHEOSTOMY NOT FOR VENTILATOR USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PMV 005</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-08T14:28:06.333Z</lastUpdated>
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  <row>
    <udiDi>20859760005022</udiDi>
    <basicUdiDi>0859760005PMV007AS</basicUdiDi>
    <tradeName>PASSY-MUIR™ TRACHEOSTOMY &amp; VENTILATOR SWALLOWING AND SPEAKING VALVE PMV™ 007 (Aqua Color™)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Passy-Muir, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000002288</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>PHONATION VALVES FOR TRACHEOSTOMY NOT FOR VENTILATOR USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PMV 007</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-08T14:28:06.286Z</lastUpdated>
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  <row>
    <udiDi>20859760005039</udiDi>
    <basicUdiDi>0859760005PMV2020JA</basicUdiDi>
    <tradeName>PASSY-MUIR™ LOW PROFILE TRACHEOSTOMY SWALLOWING AND SPEAKING VALVE PMV™ 2020 (clear)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Passy-Muir, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000002288</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>PHONATION VALVES FOR TRACHEOSTOMY NOT FOR VENTILATOR USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PMV 2020</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-08T14:28:06.232Z</lastUpdated>
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  <row>
    <udiDi>20859760005060</udiDi>
    <basicUdiDi>0859760005PMV2000J4</basicUdiDi>
    <tradeName>PASSY-MUIR™ LOW PROFILE TRACHEOSTOMY &amp; VENTILATOR SWALLOWING AND SPEAKING VALVE PMV™ 2000 (clear)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Passy-Muir, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000002288</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>PHONATION VALVES FOR TRACHEOSTOMY NOT FOR VENTILATOR USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PMV 2000</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-08T14:28:06.185Z</lastUpdated>
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  <row>
    <udiDi>20859760005084</udiDi>
    <basicUdiDi>0859760005PMA2000AV</basicUdiDi>
    <tradeName>Passy-Muir™ Valve Oxygen Adapter (PMA™ 2000)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Passy-Muir, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000002288</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>PHONATION VALVES - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PMA 2000</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-08T14:28:06.121Z</lastUpdated>
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  <row>
    <udiDi>20859760005145</udiDi>
    <basicUdiDi>0859760005PMV2001J6</basicUdiDi>
    <tradeName>PASSY-MUIR™ LOW PROFILE TRACHEOSTOMY &amp; VENTILATOR SWALLOWING AND SPEAKING VALVE PMV™ 2001 (Purple Color™)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Passy-Muir, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000002288</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>PHONATION VALVES FOR TRACHEOSTOMY NOT FOR VENTILATOR USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PMV 2001</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-08T14:28:06.063Z</lastUpdated>
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  <row>
    <udiDi>08885014610023</udiDi>
    <basicUdiDi>B-08885014610023</basicUdiDi>
    <tradeName>08885014610023</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Biobot Surgical Pte Ltd</manufacturerName>
    <manufacturerSrn>SG-MF-000020631</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>G4AA610</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-08T07:19:17.936Z</lastUpdated>
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  <row>
    <udiDi>08885014610184</udiDi>
    <basicUdiDi>888501461iSRobotKit7V</basicUdiDi>
    <tradeName>iSR'obot Kit - 13G</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Biobot Surgical Pte Ltd</manufacturerName>
    <manufacturerSrn>SG-MF-000020631</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>VARIOUS INSTRUMENTS FOR UROLOGY - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AS-00006416</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-08T07:19:17.910Z</lastUpdated>
  </row>
  <row>
    <udiDi>08885014610207</udiDi>
    <basicUdiDi>888501461iSRobotKit7V</basicUdiDi>
    <tradeName>iSR'obot Kit - 14G</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Biobot Surgical Pte Ltd</manufacturerName>
    <manufacturerSrn>SG-MF-000020631</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>VARIOUS INSTRUMENTS FOR UROLOGY - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AS-00005786</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-08T07:19:17.889Z</lastUpdated>
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  <row>
    <udiDi>08885014610221</udiDi>
    <basicUdiDi>888501461iSRobotKit7V</basicUdiDi>
    <tradeName>iSR'obot Kit - 17G</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Biobot Surgical Pte Ltd</manufacturerName>
    <manufacturerSrn>SG-MF-000020631</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>VARIOUS INSTRUMENTS FOR UROLOGY - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AS-00006415</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-08T07:19:17.867Z</lastUpdated>
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  <row>
    <udiDi>08885014610245</udiDi>
    <basicUdiDi>888501461iSRobotKit7V</basicUdiDi>
    <tradeName>08885014610245</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Biobot Surgical Pte Ltd</manufacturerName>
    <manufacturerSrn>SG-MF-000020631</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>VARIOUS INSTRUMENTS FOR UROLOGY - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AS-00005787</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-08T07:19:17.839Z</lastUpdated>
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    <udiDi>08885014610351</udiDi>
    <basicUdiDi>B-08885014610351</basicUdiDi>
    <tradeName>08885014610351</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Biobot Surgical Pte Ltd</manufacturerName>
    <manufacturerSrn>SG-MF-000020631</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>iSR'obot Mona Lisa</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-08T07:19:17.807Z</lastUpdated>
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    <udiDi>08885014610382</udiDi>
    <basicUdiDi>888501461iSRobot25</basicUdiDi>
    <tradeName>08885014610382</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Biobot Surgical Pte Ltd</manufacturerName>
    <manufacturerSrn>SG-MF-000020631</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>VARIOUS INSTRUMENTS FOR UROLOGY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>iSR'obot Mona Lisa 2.0</reference>
    <placedOnMarketCountry>Croatia</placedOnMarketCountry>
    <lastUpdated>2026-07-08T07:19:17.784Z</lastUpdated>
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    <udiDi>08885014610399</udiDi>
    <basicUdiDi>888501461iSRobot25</basicUdiDi>
    <tradeName>08885014610399</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Biobot Surgical Pte Ltd</manufacturerName>
    <manufacturerSrn>SG-MF-000020631</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>VARIOUS INSTRUMENTS FOR UROLOGY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>iSR'obot Bed Rail Stabilizer</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-08T07:19:17.758Z</lastUpdated>
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    <udiDi>08885014610429</udiDi>
    <basicUdiDi>888501461iSRobot25</basicUdiDi>
    <tradeName>08885014610429</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Biobot Surgical Pte Ltd</manufacturerName>
    <manufacturerSrn>SG-MF-000020631</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>VARIOUS INSTRUMENTS FOR UROLOGY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>iSR'obot Floor Stand Stabilizer</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-08T07:19:17.731Z</lastUpdated>
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    <udiDi>00810108710004</udiDi>
    <basicUdiDi>081010871W01030709FJ</basicUdiDi>
    <tradeName>Actin, Muscle Specific; Clone HHF35 (Ready-To-Use) 7 mL</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ScyTek Laboratories Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000023816</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>PRIMARY ANTISERA FOR IMMUNOHISTOLOGY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A00001-0007</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-08T06:58:49.198Z</lastUpdated>
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    <udiDi>00810108710011</udiDi>
    <basicUdiDi>081010871W01030709FJ</basicUdiDi>
    <tradeName>Actin, Muscle Specific; Clone HHF35 (Ready-To-Use) 25 mL</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ScyTek Laboratories Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000023816</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>PRIMARY ANTISERA FOR IMMUNOHISTOLOGY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A00001-0025</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-08T06:58:49.173Z</lastUpdated>
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