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<eudamedExport entity="devices">
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    <udiDi>09551012401053</udiDi>
    <basicUdiDi>955101240MODEL27P</basicUdiDi>
    <tradeName>IneoGuard</tradeName>
    <deviceName>Radiation Attenuating Surgical Gloves, Polyisoprene, Powder Free</deviceName>
    <manufacturerName>Ineo Tech Sdn Bhd</manufacturerName>
    <manufacturerSrn>MY-MF-000026701</manufacturerSrn>
    <authorisedRepresentativeName>Advanced Barrier Solutions SARL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000025223</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>T01010203</emdnCode>
    <emdnDescription>POLYISOPREN SURGICAL GLOVES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IG255</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T21:17:10.424Z</lastUpdated>
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  <row>
    <udiDi>09551012400971</udiDi>
    <basicUdiDi>955101240MODEL17M</basicUdiDi>
    <tradeName>IneoGuard</tradeName>
    <deviceName>Radiation Attenuating Surgical Gloves, Polyisoprene, Powder Free</deviceName>
    <manufacturerName>Ineo Tech Sdn Bhd</manufacturerName>
    <manufacturerSrn>MY-MF-000026701</manufacturerSrn>
    <authorisedRepresentativeName>Advanced Barrier Solutions SARL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000025223</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>T01010203</emdnCode>
    <emdnDescription>POLYISOPREN SURGICAL GLOVES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IG155</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T21:17:08.034Z</lastUpdated>
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    <udiDi>09551005942013</udiDi>
    <basicUdiDi>955100594100CZ</basicUdiDi>
    <tradeName>Ulma</tradeName>
    <deviceName>Sterile Latex Surgical Powder Free Gloves</deviceName>
    <manufacturerName>SENTIENX SDN. BHD.</manufacturerName>
    <manufacturerSrn>MY-MF-000023461</manufacturerSrn>
    <authorisedRepresentativeName>Ulma International GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000010015</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>T01010102</emdnCode>
    <emdnDescription>NON-POWDERED LATEX SURGICAL GLOVES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ULM-100594201</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T21:16:50.376Z</lastUpdated>
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    <udiDi>09551005941610</udiDi>
    <basicUdiDi>955100594160DK</basicUdiDi>
    <tradeName>Ulma PI Evolution</tradeName>
    <deviceName>Sterile Polyisoprene Surgical Powder Free Gloves</deviceName>
    <manufacturerName>SENTIENX SDN. BHD.</manufacturerName>
    <manufacturerSrn>MY-MF-000023461</manufacturerSrn>
    <authorisedRepresentativeName>Ulma International GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000010015</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>T01010203</emdnCode>
    <emdnDescription>POLYISOPREN SURGICAL GLOVES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>UPE-100594161</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T21:16:48.742Z</lastUpdated>
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  <row>
    <udiDi>09551005941214</udiDi>
    <basicUdiDi>955100594120D7</basicUdiDi>
    <tradeName>Ulma CR</tradeName>
    <deviceName>Sterile Polychloroprene Surgical Powder Free Gloves</deviceName>
    <manufacturerName>SENTIENX SDN. BHD.</manufacturerName>
    <manufacturerSrn>MY-MF-000023461</manufacturerSrn>
    <authorisedRepresentativeName>Ulma International GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000010015</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>T01010201</emdnCode>
    <emdnDescription>POLYCHLOROPREN SURGICAL GLOVES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ULC-100594121</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T21:16:46.356Z</lastUpdated>
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  <row>
    <udiDi>09551005940613</udiDi>
    <basicUdiDi>955100594060DE</basicUdiDi>
    <tradeName>Ulma</tradeName>
    <deviceName>Sterile Latex Surgical Powdered Glove</deviceName>
    <manufacturerName>SENTIENX SDN. BHD.</manufacturerName>
    <manufacturerSrn>MY-MF-000023461</manufacturerSrn>
    <authorisedRepresentativeName>Ulma International GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000010015</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>T01010101</emdnCode>
    <emdnDescription>POWDERED LATEX SURGICAL GLOVES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ULM-100594061</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T21:16:44.752Z</lastUpdated>
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  <row>
    <udiDi>09551005940217</udiDi>
    <basicUdiDi>955100594020D2</basicUdiDi>
    <tradeName>Finessis Corium</tradeName>
    <deviceName>Sterile Flexylon Surgical Powder Free Glove</deviceName>
    <manufacturerName>SENTIENX SDN. BHD.</manufacturerName>
    <manufacturerSrn>MY-MF-000023461</manufacturerSrn>
    <authorisedRepresentativeName>Ulma International GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000010015</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>T010199</emdnCode>
    <emdnDescription>SURGICAL GLOVES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FZC-100594021</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T21:16:44.010Z</lastUpdated>
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  <row>
    <udiDi>09551005940019</udiDi>
    <basicUdiDi>955100594000CU</basicUdiDi>
    <tradeName>Finessis Zero</tradeName>
    <deviceName>Sterile Flexylon Surgical Powder Free Gloves</deviceName>
    <manufacturerName>SENTIENX SDN. BHD.</manufacturerName>
    <manufacturerSrn>MY-MF-000023461</manufacturerSrn>
    <authorisedRepresentativeName>Ulma International GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000010015</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>T010199</emdnCode>
    <emdnDescription>SURGICAL GLOVES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FZR-100594001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T21:16:42.346Z</lastUpdated>
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  <row>
    <udiDi>09551003452149</udiDi>
    <basicUdiDi>955100345125B7</basicUdiDi>
    <tradeName>KING</tradeName>
    <deviceName>Powdered Latex Surgical Gloves</deviceName>
    <manufacturerName>Supermax Glove Manufacturing Sdn Bhd</manufacturerName>
    <manufacturerSrn>MY-MF-000016722</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>T01010101</emdnCode>
    <emdnDescription>POWDERED LATEX SURGICAL GLOVES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6.0</reference>
    <placedOnMarketCountry>Portugal</placedOnMarketCountry>
    <lastUpdated>2026-07-03T21:16:31.140Z</lastUpdated>
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  <row>
    <udiDi>09001570557797</udiDi>
    <basicUdiDi>9001570PFM-116SC-S-64V</basicUdiDi>
    <tradeName>sempermed syntegra preCision</tradeName>
    <deviceName></deviceName>
    <manufacturerName>HARPS Investment Asia Pte. Ltd.</manufacturerName>
    <manufacturerSrn>SG-MF-000001645</manufacturerSrn>
    <authorisedRepresentativeName>HARPS Europe GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>AT-AR-000040870</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>T01010203</emdnCode>
    <emdnDescription>POLYISOPREN SURGICAL GLOVES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3000016672</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-03T20:44:26.838Z</lastUpdated>
  </row>
  <row>
    <udiDi>08997030302001</udiDi>
    <basicUdiDi>899703030NRSGRV</basicUdiDi>
    <tradeName>DURASENSE</tradeName>
    <deviceName>Powder Free Natural Rubber Latex Sterile Surgical Gloves</deviceName>
    <manufacturerName>PT. Medisafe Technologies</manufacturerName>
    <manufacturerSrn>ID-MF-000017133</manufacturerSrn>
    <authorisedRepresentativeName>Theo Manufacturing B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000006691</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>T01010102</emdnCode>
    <emdnDescription>NON-POWDERED LATEX SURGICAL GLOVES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NR-SG-127</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-03T20:44:08.429Z</lastUpdated>
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  <row>
    <udiDi>08997030300175</udiDi>
    <basicUdiDi>899703030CRSGPG</basicUdiDi>
    <tradeName>CHLOROSENSE</tradeName>
    <deviceName>Powder Free Polychloroprene Sterile Surgical Gloves</deviceName>
    <manufacturerName>PT. Medisafe Technologies</manufacturerName>
    <manufacturerSrn>ID-MF-000017133</manufacturerSrn>
    <authorisedRepresentativeName>Theo Manufacturing B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000006691</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>T01010201</emdnCode>
    <emdnDescription>POLYCHLOROPREN SURGICAL GLOVES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CR-SG-130-WH</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-03T20:44:07.645Z</lastUpdated>
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  <row>
    <udiDi>08997030302025</udiDi>
    <basicUdiDi>899703030IRSGQS</basicUdiDi>
    <tradeName>Isosense</tradeName>
    <deviceName>Powder Free Polyisoprene Sterile Surgical Gloves</deviceName>
    <manufacturerName>PT. Medisafe Technologies</manufacturerName>
    <manufacturerSrn>ID-MF-000017133</manufacturerSrn>
    <authorisedRepresentativeName>Theo Manufacturing B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000006691</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>T01010203</emdnCode>
    <emdnDescription>POLYISOPREN SURGICAL GLOVES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Powder Free Polyisoprene Sterile Surgical Gloves, Size 6 (1R-SG-119-WH)</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-03T20:44:06.021Z</lastUpdated>
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  <row>
    <udiDi>08908019791167</udiDi>
    <basicUdiDi>89080197910LSGPDEG</basicUdiDi>
    <tradeName>Pristeen++</tradeName>
    <deviceName>Latex Surgical Gloves Powdered - Pristeen++, Surgilex Plus, Pristeen, Easy flow</deviceName>
    <manufacturerName>Beta Health Care Products Pvt Ltd</manufacturerName>
    <manufacturerSrn>IN-MF-000019439</manufacturerSrn>
    <authorisedRepresentativeName>Amstermed B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001971</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>T01010101</emdnCode>
    <emdnDescription>POWDERED LATEX SURGICAL GLOVES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LSGPD</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-03T19:08:09.535Z</lastUpdated>
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  <row>
    <udiDi>08908019791860</udiDi>
    <basicUdiDi>89080197910LSGPFEL</basicUdiDi>
    <tradeName>LUVAS CIRÚRGICAS SEM PÓ ORIGINPHARMA</tradeName>
    <deviceName>Latex Surgical Glove Powder Free -  Pristeen++, Surgilex, Medi-Grip Latex PF, LUVAS CIRURGICAS SEM PO ORGINPHARMA</deviceName>
    <manufacturerName>Beta Health Care Products Pvt Ltd</manufacturerName>
    <manufacturerSrn>IN-MF-000019439</manufacturerSrn>
    <authorisedRepresentativeName>Amstermed B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001971</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>T01010102</emdnCode>
    <emdnDescription>NON-POWDERED LATEX SURGICAL GLOVES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>REF_LUVAS</reference>
    <placedOnMarketCountry>Portugal</placedOnMarketCountry>
    <lastUpdated>2026-07-03T19:08:07.927Z</lastUpdated>
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    <udiDi>08908000843349</udiDi>
    <basicUdiDi>8908000843LSGPF9E</basicUdiDi>
    <tradeName>PRISTEEN</tradeName>
    <deviceName>Sterile Latex Surgical Gloves Powder Free - Pristeen, Perfekto, Protezine, Hospicare, Gant D'Intervention chirugicale</deviceName>
    <manufacturerName>Beta Health Care Products Pvt Ltd</manufacturerName>
    <manufacturerSrn>IN-MF-000019439</manufacturerSrn>
    <authorisedRepresentativeName>Amstermed B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001971</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>T01010102</emdnCode>
    <emdnDescription>NON-POWDERED LATEX SURGICAL GLOVES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NA</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-07-03T19:05:23.645Z</lastUpdated>
  </row>
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    <udiDi>08908000843240</udiDi>
    <basicUdiDi>8908000843LSGPD9A</basicUdiDi>
    <tradeName>Pristeen</tradeName>
    <deviceName>Latex Surgical Gloves Powdered - Pristeen, Perfekto, Protezine, Luvas COM PO Originpharma</deviceName>
    <manufacturerName>Beta Health Care Products Pvt Ltd</manufacturerName>
    <manufacturerSrn>IN-MF-000019439</manufacturerSrn>
    <authorisedRepresentativeName>Amstermed B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001971</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>T01010101</emdnCode>
    <emdnDescription>POWDERED LATEX SURGICAL GLOVES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NA</reference>
    <placedOnMarketCountry>Portugal</placedOnMarketCountry>
    <lastUpdated>2026-07-03T19:05:22.846Z</lastUpdated>
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    <udiDi>08904448602654</udiDi>
    <basicUdiDi>8908004933SLGPF2JH</basicUdiDi>
    <tradeName>Medismart +</tradeName>
    <deviceName>Sterile Latex Gynaecological Gloves Powder Free(Polymer coated)</deviceName>
    <manufacturerName>St.Marys Rubbers Pvt. Ltd.</manufacturerName>
    <manufacturerSrn>IN-MF-000008817</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>T01010102</emdnCode>
    <emdnDescription>NON-POWDERED LATEX SURGICAL GLOVES</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>1LG16PF-1175</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-03T19:02:47.417Z</lastUpdated>
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    <udiDi>08904448602142</udiDi>
    <basicUdiDi>8908004933SLSPP1MZ</basicUdiDi>
    <tradeName>Medismart</tradeName>
    <deviceName>Sterile Latex Surgical  Gloves Powdered</deviceName>
    <manufacturerName>St.Marys Rubbers Pvt. Ltd.</manufacturerName>
    <manufacturerSrn>IN-MF-000008817</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>T01010101</emdnCode>
    <emdnDescription>POWDERED LATEX SURGICAL GLOVES</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>1LSPP- 1175</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-03T19:02:46.619Z</lastUpdated>
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    <udiDi>08904448602074</udiDi>
    <basicUdiDi>8908004933SLGPP1KD</basicUdiDi>
    <tradeName>Medismart</tradeName>
    <deviceName>Sterile Latex Gynaecological Gloves Powdered</deviceName>
    <manufacturerName>St.Marys Rubbers Pvt. Ltd.</manufacturerName>
    <manufacturerSrn>IN-MF-000008817</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>T01010101</emdnCode>
    <emdnDescription>POWDERED LATEX SURGICAL GLOVES</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>1LG18PP- 1 1 7 5</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-03T19:02:45.822Z</lastUpdated>
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