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<eudamedExport entity="devices">
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    <basicUdiDi>B-00849405002482</basicUdiDi>
    <tradeName>DUO Canister Set 400 cc</tradeName>
    <deviceName>DUO Canister Set 400 cc</deviceName>
    <manufacturerName>Genadyne Biotechnologies, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000017992</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A060301</emdnCode>
    <emdnDescription>COLLECTION BAGS AND OTHER CONTAINERS FOR DRAINAGES AND FISTULAS, SINGLE USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A7-S00D4</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-05T07:41:16.198Z</lastUpdated>
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  <row>
    <udiDi>00849405002321</udiDi>
    <basicUdiDi>B-00849405002321</basicUdiDi>
    <tradeName>UNO+ 100 CC</tradeName>
    <deviceName>UNO Plus 100 CC Collection Canister</deviceName>
    <manufacturerName>Genadyne Biotechnologies, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000017992</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A060301</emdnCode>
    <emdnDescription>COLLECTION BAGS AND OTHER CONTAINERS FOR DRAINAGES AND FISTULAS, SINGLE USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>UP-S00D1</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-05T07:40:54.587Z</lastUpdated>
  </row>
  <row>
    <udiDi>00849405002222</udiDi>
    <basicUdiDi>B-00849405002222</basicUdiDi>
    <tradeName>DUO Canister Set 800 cc</tradeName>
    <deviceName>DUO Canister Set 800 cc</deviceName>
    <manufacturerName>Genadyne Biotechnologies, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000017992</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A060301</emdnCode>
    <emdnDescription>COLLECTION BAGS AND OTHER CONTAINERS FOR DRAINAGES AND FISTULAS, SINGLE USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A7-S00D8</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-05T07:40:48.166Z</lastUpdated>
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  <row>
    <udiDi>00849405002215</udiDi>
    <basicUdiDi>B-00849405002215</basicUdiDi>
    <tradeName>DUO Canister Set 1100 cc</tradeName>
    <deviceName>DUO Canister 1100 cc</deviceName>
    <manufacturerName>Genadyne Biotechnologies, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000017992</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A060301</emdnCode>
    <emdnDescription>COLLECTION BAGS AND OTHER CONTAINERS FOR DRAINAGES AND FISTULAS, SINGLE USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A7-S00D11</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-05T07:40:43.369Z</lastUpdated>
  </row>
  <row>
    <udiDi>00849405002208</udiDi>
    <basicUdiDi>B-00849405002208</basicUdiDi>
    <tradeName>DUO Canister Set 600 cc</tradeName>
    <deviceName>DUO Canister Set 600 cc</deviceName>
    <manufacturerName>Genadyne Biotechnologies, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000017992</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A060301</emdnCode>
    <emdnDescription>COLLECTION BAGS AND OTHER CONTAINERS FOR DRAINAGES AND FISTULAS, SINGLE USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A7-S00D6</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-05T07:40:42.564Z</lastUpdated>
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  <row>
    <udiDi>00849405001058</udiDi>
    <basicUdiDi>B-00849405001058</basicUdiDi>
    <tradeName>UNO 70cc CANISTER</tradeName>
    <deviceName>UNO 70cc Canister</deviceName>
    <manufacturerName>Genadyne Biotechnologies, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000017992</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A060301</emdnCode>
    <emdnDescription>COLLECTION BAGS AND OTHER CONTAINERS FOR DRAINAGES AND FISTULAS, SINGLE USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>U-C070</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-05T07:40:00.085Z</lastUpdated>
  </row>
  <row>
    <udiDi>00849405000488</udiDi>
    <basicUdiDi>B-00849405000488</basicUdiDi>
    <tradeName>UNO+ 300 CC</tradeName>
    <deviceName>UNO Plus 300 CC Collection Canister</deviceName>
    <manufacturerName>Genadyne Biotechnologies, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000017992</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A060301</emdnCode>
    <emdnDescription>COLLECTION BAGS AND OTHER CONTAINERS FOR DRAINAGES AND FISTULAS, SINGLE USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>UP-S00D3</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-05T07:39:07.212Z</lastUpdated>
  </row>
  <row>
    <udiDi>00849405000426</udiDi>
    <basicUdiDi>B-00849405000426</basicUdiDi>
    <tradeName>XLR8 1100 CC Canister</tradeName>
    <deviceName>XLR8 1100 cc Canister</deviceName>
    <manufacturerName>Genadyne Biotechnologies, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000017992</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A060301</emdnCode>
    <emdnDescription>COLLECTION BAGS AND OTHER CONTAINERS FOR DRAINAGES AND FISTULAS, SINGLE USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A4-S00D11</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T07:39:00.806Z</lastUpdated>
  </row>
  <row>
    <udiDi>00849405000419</udiDi>
    <basicUdiDi>B-00849405000419</basicUdiDi>
    <tradeName>XLR8 800 CC Canister</tradeName>
    <deviceName>XLR8 800 cc Canister</deviceName>
    <manufacturerName>Genadyne Biotechnologies, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000017992</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A060301</emdnCode>
    <emdnDescription>COLLECTION BAGS AND OTHER CONTAINERS FOR DRAINAGES AND FISTULAS, SINGLE USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A4-S00D8</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T07:39:00.021Z</lastUpdated>
  </row>
  <row>
    <udiDi>00849405000402</udiDi>
    <basicUdiDi>B-00849405000402</basicUdiDi>
    <tradeName>XLR8 600 CC Canister</tradeName>
    <deviceName>XLR8 600 cc Canister</deviceName>
    <manufacturerName>Genadyne Biotechnologies, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000017992</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A060301</emdnCode>
    <emdnDescription>COLLECTION BAGS AND OTHER CONTAINERS FOR DRAINAGES AND FISTULAS, SINGLE USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A4-S00D6</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T07:38:55.199Z</lastUpdated>
  </row>
  <row>
    <udiDi>00849405000396</udiDi>
    <basicUdiDi>B-00849405000396</basicUdiDi>
    <tradeName>XLR8 200 CC Canister</tradeName>
    <deviceName>XLR8 200 cc Canister</deviceName>
    <manufacturerName>Genadyne Biotechnologies, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000017992</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A060301</emdnCode>
    <emdnDescription>COLLECTION BAGS AND OTHER CONTAINERS FOR DRAINAGES AND FISTULAS, SINGLE USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A4-S00D2</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T07:38:54.398Z</lastUpdated>
  </row>
  <row>
    <udiDi>00849405000389</udiDi>
    <basicUdiDi>B-00849405000389</basicUdiDi>
    <tradeName>UNO+ 200 CC</tradeName>
    <deviceName>UNO Plus 200 CC Collection Canister</deviceName>
    <manufacturerName>Genadyne Biotechnologies, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000017992</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A060301</emdnCode>
    <emdnDescription>COLLECTION BAGS AND OTHER CONTAINERS FOR DRAINAGES AND FISTULAS, SINGLE USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>UP-S00D2</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-05T07:38:53.607Z</lastUpdated>
  </row>
  <row>
    <udiDi>00849405000051</udiDi>
    <basicUdiDi>B-00849405000051</basicUdiDi>
    <tradeName>XLR8 400 CC Canister</tradeName>
    <deviceName>XLR8 400 cc Canister</deviceName>
    <manufacturerName>Genadyne Biotechnologies, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000017992</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>A060301</emdnCode>
    <emdnDescription>COLLECTION BAGS AND OTHER CONTAINERS FOR DRAINAGES AND FISTULAS, SINGLE USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A4-S00D4</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T07:38:41.588Z</lastUpdated>
  </row>
  <row>
    <udiDi>08902120511010</udiDi>
    <basicUdiDi>8902120F005SK</basicUdiDi>
    <tradeName>BILE BAG</tradeName>
    <deviceName>Bile Collection Bag</deviceName>
    <manufacturerName>Romsons International (Unit II)</manufacturerName>
    <manufacturerSrn>IN-MF-000024594</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A060301</emdnCode>
    <emdnDescription>COLLECTION BAGS AND OTHER CONTAINERS FOR DRAINAGES AND FISTULAS, SINGLE USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GS-5110</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T18:25:35.709Z</lastUpdated>
  </row>
  <row>
    <udiDi>08720795808026</udiDi>
    <basicUdiDi>87207958ZS-WM25</basicUdiDi>
    <tradeName>Zenso</tradeName>
    <deviceName>Zenso wound and fistula pouch</deviceName>
    <manufacturerName>Oxmed International BV</manufacturerName>
    <manufacturerSrn>NL-MF-000025538</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A060301</emdnCode>
    <emdnDescription>COLLECTION BAGS AND OTHER CONTAINERS FOR DRAINAGES AND FISTULAS, SINGLE USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Z10B00</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-03T16:55:27.620Z</lastUpdated>
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  <row>
    <udiDi>08034139291598</udiDi>
    <basicUdiDi>803413929BAG1a3F</basicUdiDi>
    <tradeName>Sacca 600 ml per circuito chiuso</tradeName>
    <deviceName>SACCA DRENAGGIO ALIVIA 2000 ML</deviceName>
    <manufacturerName>Redax S.p.A.</manufacturerName>
    <manufacturerSrn>IT-MF-000019320</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A060301</emdnCode>
    <emdnDescription>COLLECTION BAGS AND OTHER CONTAINERS FOR DRAINAGES AND FISTULAS, SINGLE USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>12004</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T05:28:37.261Z</lastUpdated>
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    <udiDi>06979419450000</udiDi>
    <basicUdiDi>697941945DrainageBagWG</basicUdiDi>
    <tradeName>06979419450000</tradeName>
    <deviceName>Disposable Drainage Bag</deviceName>
    <manufacturerName>Sanmen Minsheng Medical Appliances Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000051043</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A060301</emdnCode>
    <emdnDescription>COLLECTION BAGS AND OTHER CONTAINERS FOR DRAINAGES AND FISTULAS, SINGLE USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>350ml</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-02T21:42:42.202Z</lastUpdated>
  </row>
  <row>
    <udiDi>06978670910490</udiDi>
    <basicUdiDi>697867091HS5621QB</basicUdiDi>
    <tradeName>disposal container</tradeName>
    <deviceName>disposal container</deviceName>
    <manufacturerName>Danyang New Hope Medical Equipment Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000027193</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A060301</emdnCode>
    <emdnDescription>COLLECTION BAGS AND OTHER CONTAINERS FOR DRAINAGES AND FISTULAS, SINGLE USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HS5612-12L</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-02T20:54:24.125Z</lastUpdated>
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    <udiDi>06978563360005</udiDi>
    <basicUdiDi>697856336XPDBXG</basicUdiDi>
    <tradeName>06978563360005</tradeName>
    <deviceName>Drainage Bag</deviceName>
    <manufacturerName>Changzhou Cippor Medical Equipment Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000047243</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A060301</emdnCode>
    <emdnDescription>COLLECTION BAGS AND OTHER CONTAINERS FOR DRAINAGES AND FISTULAS, SINGLE USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>100ml</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-02T20:42:35.750Z</lastUpdated>
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  <row>
    <udiDi>06977860251016</udiDi>
    <basicUdiDi>697786025ZDDBUX</basicUdiDi>
    <tradeName>Drainage Bag</tradeName>
    <deviceName>Drainage Bag</deviceName>
    <manufacturerName>Zhida Medical Device Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000044334</manufacturerSrn>
    <authorisedRepresentativeName>MedPath GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000087</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A060301</emdnCode>
    <emdnDescription>COLLECTION BAGS AND OTHER CONTAINERS FOR DRAINAGES AND FISTULAS, SINGLE USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>350ml</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T20:05:10.410Z</lastUpdated>
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