<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>00850034511160</udiDi>
    <basicUdiDi>B-00850034511160</basicUdiDi>
    <tradeName>Puregraft 850</tradeName>
    <deviceName>Puregraft 850</deviceName>
    <manufacturerName>Bimini Health Tech</manufacturerName>
    <manufacturerSrn>US-MF-000008649</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A99</emdnCode>
    <emdnDescription>DEVICES FOR ADMINISTRATION, WITHDRAWAL AND COLLECTION - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>850/PURE</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:01:19.164Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850034511146</udiDi>
    <basicUdiDi>B-00850034511146</basicUdiDi>
    <tradeName>Puregraft 250</tradeName>
    <deviceName>Puregraft 250</deviceName>
    <manufacturerName>Bimini Health Tech</manufacturerName>
    <manufacturerSrn>US-MF-000008649</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A99</emdnCode>
    <emdnDescription>DEVICES FOR ADMINISTRATION, WITHDRAWAL AND COLLECTION - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>250/PURE</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:01:15.158Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850034511115</udiDi>
    <basicUdiDi>B-00850034511115</basicUdiDi>
    <tradeName>Puregraft 50 Single Pack</tradeName>
    <deviceName>50/PURE Single Pack</deviceName>
    <manufacturerName>Bimini Health Tech</manufacturerName>
    <manufacturerSrn>US-MF-000008649</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A99</emdnCode>
    <emdnDescription>DEVICES FOR ADMINISTRATION, WITHDRAWAL AND COLLECTION - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>50/PURE-1</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:01:14.359Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850034511085</udiDi>
    <basicUdiDi>B-00850034511085</basicUdiDi>
    <tradeName>Healeon Duet</tradeName>
    <deviceName>Healeon Duet</deviceName>
    <manufacturerName>Bimini Health Tech</manufacturerName>
    <manufacturerSrn>US-MF-000008649</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>B06</emdnCode>
    <emdnDescription>CELLULAR OR BIOLOGICAL MANIPULATION DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HM-DUET</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:01:13.582Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850034511122</udiDi>
    <basicUdiDi>085003451150/PUREAA</basicUdiDi>
    <tradeName>Puregraft 50</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Bimini Health Tech</manufacturerName>
    <manufacturerSrn>US-MF-000008649</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>LIPOSUCTION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>50/PURE</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-25T14:52:57.515Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850034511016</udiDi>
    <basicUdiDi>0850034511ADAPTKN</basicUdiDi>
    <tradeName>00850034511016</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Bimini Health Tech</manufacturerName>
    <manufacturerSrn>US-MF-000008649</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>GENERAL SURGERY ADAPTERS AND CONNECTORS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ADAPT/PURE</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T22:45:17.406Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850034511030</udiDi>
    <basicUdiDi>0850034511IS8B</basicUdiDi>
    <tradeName>00850034511030</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Bimini Health Tech</manufacturerName>
    <manufacturerSrn>US-MF-000008649</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>INSTRUMENTS FOR SUPPORT OF SURGICAL DEVICES, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>550/IS SST</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T22:45:17.395Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850034511054</udiDi>
    <basicUdiDi>0850034511PVLZL</basicUdiDi>
    <tradeName>00850034511054</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Bimini Health Tech</manufacturerName>
    <manufacturerSrn>US-MF-000008649</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>LIPOSUCTION INSTRUMENTS, REUSABLE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PVL/PURE</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T22:45:17.378Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850034511184</udiDi>
    <basicUdiDi>0850034511250/PURE8J</basicUdiDi>
    <tradeName>Puregraft 250</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Bimini Health Tech</manufacturerName>
    <manufacturerSrn>US-MF-000008649</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>LIPOSUCTION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>250/PURE</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T22:45:17.227Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850034511207</udiDi>
    <basicUdiDi>0850034511850/PUREC4</basicUdiDi>
    <tradeName>Puregraft 850</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Bimini Health Tech</manufacturerName>
    <manufacturerSrn>US-MF-000008649</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>LIPOSUCTION SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>850/PURE</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T22:45:17.205Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850034511306</udiDi>
    <basicUdiDi>0850034511REFRESH76</basicUdiDi>
    <tradeName>Dermapose</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Bimini Health Tech</manufacturerName>
    <manufacturerSrn>US-MF-000008649</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>LIPOSUCTION SYSTEMS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>REFRESH</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T22:45:17.185Z</lastUpdated>
  </row>
</eudamedExport>