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<eudamedExport entity="devices">
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    <tradeName>Multipurpose Handling Medium (MHM) with Gentamicin</tradeName>
    <deviceName>Multipurpose Handling Medium (MHM) with Gentamicin</deviceName>
    <manufacturerName>Irvine Scientific, LLC.</manufacturerName>
    <manufacturerSrn>US-MF-000007514</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U08020502</emdnCode>
    <emdnDescription>MATERIALS/SOLUTIONS FOR PREPARATION/HANDLING FOR ASSISTED REPRODUCTION</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>90163</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-01T07:41:01.212Z</lastUpdated>
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  <row>
    <udiDi>00810195240248</udiDi>
    <basicUdiDi>B-00810195240248</basicUdiDi>
    <tradeName>Multipurpose Handling Medium (MHM) with Gentamicin</tradeName>
    <deviceName>Multipurpose Handling Medium (MHM) with Gentamicin</deviceName>
    <manufacturerName>Irvine Scientific, LLC.</manufacturerName>
    <manufacturerSrn>US-MF-000007514</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U08020502</emdnCode>
    <emdnDescription>MATERIALS/SOLUTIONS FOR PREPARATION/HANDLING FOR ASSISTED REPRODUCTION</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>90163</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-01T07:40:59.617Z</lastUpdated>
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    <udiDi>00810195240231</udiDi>
    <basicUdiDi>B-00810195240231</basicUdiDi>
    <tradeName>Hyaluronidase Solution</tradeName>
    <deviceName>Hyaluronidase Solution</deviceName>
    <manufacturerName>Irvine Scientific, LLC.</manufacturerName>
    <manufacturerSrn>US-MF-000007514</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U08020502</emdnCode>
    <emdnDescription>MATERIALS/SOLUTIONS FOR PREPARATION/HANDLING FOR ASSISTED REPRODUCTION</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>90101</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-01T07:40:58.815Z</lastUpdated>
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    <udiDi>00810195240217</udiDi>
    <basicUdiDi>B-00810195240217</basicUdiDi>
    <tradeName>Oil for Embryo Culture</tradeName>
    <deviceName>Oil for Embryo Culture</deviceName>
    <manufacturerName>Irvine Scientific, LLC.</manufacturerName>
    <manufacturerSrn>US-MF-000007514</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U08020502</emdnCode>
    <emdnDescription>MATERIALS/SOLUTIONS FOR PREPARATION/HANDLING FOR ASSISTED REPRODUCTION</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9305-100mL</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-01T07:40:57.221Z</lastUpdated>
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  <row>
    <udiDi>00810195240187</udiDi>
    <basicUdiDi>B-00810195240187</basicUdiDi>
    <tradeName>Human Serum Albumin (HSA)</tradeName>
    <deviceName>Human Serum Albumin</deviceName>
    <manufacturerName>Irvine Scientific, LLC.</manufacturerName>
    <manufacturerSrn>US-MF-000007514</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U08020502</emdnCode>
    <emdnDescription>MATERIALS/SOLUTIONS FOR PREPARATION/HANDLING FOR ASSISTED REPRODUCTION</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9988</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-01T07:40:54.811Z</lastUpdated>
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  <row>
    <udiDi>00810195240163</udiDi>
    <basicUdiDi>B-00810195240163</basicUdiDi>
    <tradeName>Freezing Medium - Test Yolk Buffer (TYB) with Glycerol and Gentamicin</tradeName>
    <deviceName>Freezing Medium - Test Yolk Buffer (TYB) with Glycerol and Gentamicin</deviceName>
    <manufacturerName>Irvine Scientific, LLC.</manufacturerName>
    <manufacturerSrn>US-MF-000007514</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U08020501</emdnCode>
    <emdnDescription>MATERIALS/SOLUTIONS FOR FREEZING/THAWING FOR ASSISTED REPRODUCTION</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>90128</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-01T07:40:53.210Z</lastUpdated>
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    <udiDi>19556807300563</udiDi>
    <basicUdiDi>9556807CD001UF</basicUdiDi>
    <tradeName>EXS Nano Thin</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Richter Rubber Technology Sdn Bhd</manufacturerName>
    <manufacturerSrn>MY-MF-000023324</manufacturerSrn>
    <authorisedRepresentativeName>rrt Vertrieb und Service GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000021443</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>U110101</emdnCode>
    <emdnDescription>CONDOMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>QA-224</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T21:54:08.523Z</lastUpdated>
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    <udiDi>19556081080014</udiDi>
    <basicUdiDi>955608153585001TH</basicUdiDi>
    <tradeName>Shadow</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Dongkuk Techco Rubber Industries Sdn. Bhd.</manufacturerName>
    <manufacturerSrn>MY-MF-000026104</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>U110101</emdnCode>
    <emdnDescription>CONDOMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NA</reference>
    <placedOnMarketCountry>Portugal</placedOnMarketCountry>
    <lastUpdated>2026-07-31T21:54:08.446Z</lastUpdated>
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  <row>
    <udiDi>09555012423022</udiDi>
    <basicUdiDi>955501242LC0013W</basicUdiDi>
    <tradeName>Fiesta Maksimum</tradeName>
    <deviceName>NATURAL RUBBER LATEX MALE CONDOM</deviceName>
    <manufacturerName>PLEASURE LATEX PRODUCTS SDN. BHD.</manufacturerName>
    <manufacturerSrn>MY-MF-000016199</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U110101</emdnCode>
    <emdnDescription>CONDOMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FMM1</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-31T21:53:10.746Z</lastUpdated>
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  <row>
    <udiDi>05711732118684</udiDi>
    <basicUdiDi>955516330-NMCM-6F</basicUdiDi>
    <tradeName>Sinful Let’s Talk About Sex</tradeName>
    <deviceName>Non-sterile Non-medicated Natural Rubber Latex Male Condoms</deviceName>
    <manufacturerName>Innolatex Sdn. Bhd.</manufacturerName>
    <manufacturerSrn>MY-MF-000001246</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U110101</emdnCode>
    <emdnDescription>CONDOMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>29104</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-31T21:52:45.942Z</lastUpdated>
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  <row>
    <udiDi>03564700582176</udiDi>
    <basicUdiDi>955545180-NMCM-9Y</basicUdiDi>
    <tradeName>Plug In Purefeeling Protection Classique</tradeName>
    <deviceName>Non-sterile Non-medicated Natural Rubber Latex Male Condoms.</deviceName>
    <manufacturerName>Medical-Latex (DUA) Sdn. Bhd.</manufacturerName>
    <manufacturerSrn>MY-MF-000001244</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U110101</emdnCode>
    <emdnDescription>CONDOMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>T54BH-N4</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-31T21:52:27.830Z</lastUpdated>
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    <udiDi>00726893116054</udiDi>
    <basicUdiDi>9556564-NMCMGO-ZN</basicUdiDi>
    <tradeName>ONE® Flex®</tradeName>
    <deviceName>Non-sterile, Non-medicated Natural Rubber Latex Male Condom (Reduced Graphene Oxide (rGO) Latex Composite Male Condoms)</deviceName>
    <manufacturerName>Karex Industries Sdn. Bhd.</manufacturerName>
    <manufacturerSrn>MY-MF-000001247</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U110101</emdnCode>
    <emdnDescription>CONDOMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1131310</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-31T21:52:23.457Z</lastUpdated>
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  <row>
    <udiDi>00726893114982</udiDi>
    <basicUdiDi>9556564-NMCM-U4</basicUdiDi>
    <tradeName>ONE® Mixed Pleasures™</tradeName>
    <deviceName>Non-sterile, Non-medicated Natural Rubber Latex Male Condoms</deviceName>
    <manufacturerName>Karex Industries Sdn. Bhd.</manufacturerName>
    <manufacturerSrn>MY-MF-000001247</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U110101</emdnCode>
    <emdnDescription>CONDOMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>110132</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-31T21:52:22.672Z</lastUpdated>
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    <udiDi>08906155701743</udiDi>
    <basicUdiDi>890615570SDYV</basicUdiDi>
    <tradeName>UROMED</tradeName>
    <deviceName>Screw Dilator &amp; Set</deviceName>
    <manufacturerName>MANISH MEDI INNOVATION PRIVATE LIMITED</manufacturerName>
    <manufacturerSrn>IN-MF-000039093</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U03010199</emdnCode>
    <emdnDescription>PERCUTANEOUS NEPHROSTOMY, SEQUENTIAL DILATORS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SDS8/2430</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-31T21:27:34.925Z</lastUpdated>
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    <udiDi>08906155700876</udiDi>
    <basicUdiDi>890615570SPCSLN4</basicUdiDi>
    <tradeName>UROMED</tradeName>
    <deviceName>Suprapubic Catheterisation Set - Latex</deviceName>
    <manufacturerName>MANISH MEDI INNOVATION PRIVATE LIMITED</manufacturerName>
    <manufacturerSrn>IN-MF-000039093</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U040199</emdnCode>
    <emdnDescription>DEVICES FOR SUPRAPUBIC URINARY DRAINAGE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SPC8040L</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-31T21:27:34.463Z</lastUpdated>
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    <udiDi>08906155700807</udiDi>
    <basicUdiDi>890615570SPCSSNJ</basicUdiDi>
    <tradeName>UROMED</tradeName>
    <deviceName>Suprapubic Catheterisation Set - Silicone</deviceName>
    <manufacturerName>MANISH MEDI INNOVATION PRIVATE LIMITED</manufacturerName>
    <manufacturerSrn>IN-MF-000039093</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U040199</emdnCode>
    <emdnDescription>DEVICES FOR SUPRAPUBIC URINARY DRAINAGE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SPC6030S</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-31T21:27:30.124Z</lastUpdated>
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    <udiDi>08906155700586</udiDi>
    <basicUdiDi>890615570MCSQH</basicUdiDi>
    <tradeName>UROMED</tradeName>
    <deviceName>Malecot Nephrostomy Drainage Catheter &amp; Set</deviceName>
    <manufacturerName>MANISH MEDI INNOVATION PRIVATE LIMITED</manufacturerName>
    <manufacturerSrn>IN-MF-000039093</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U040202</emdnCode>
    <emdnDescription>NEPHROSTOMY KITS, SELDINGER METHOD</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MC8030S</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-31T21:27:29.322Z</lastUpdated>
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    <udiDi>08906155700302</udiDi>
    <basicUdiDi>890615570PCNWNSPS</basicUdiDi>
    <tradeName>UROMED</tradeName>
    <deviceName>percutaneous nephrostomy drainage catheter with needle</deviceName>
    <manufacturerName>MANISH MEDI INNOVATION PRIVATE LIMITED</manufacturerName>
    <manufacturerSrn>IN-MF-000039093</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U040202</emdnCode>
    <emdnDescription>NEPHROSTOMY KITS, SELDINGER METHOD</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PNN6022</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-31T21:27:28.670Z</lastUpdated>
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    <basicUdiDi>890615570PCNSLT</basicUdiDi>
    <tradeName>UROMED</tradeName>
    <deviceName>Percutaneous Nephrostomy Drainage Catheter &amp; Set</deviceName>
    <manufacturerName>MANISH MEDI INNOVATION PRIVATE LIMITED</manufacturerName>
    <manufacturerSrn>IN-MF-000039093</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U040202</emdnCode>
    <emdnDescription>NEPHROSTOMY KITS, SELDINGER METHOD</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PCN6030</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-31T21:27:28.122Z</lastUpdated>
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    <basicUdiDi>890615570SBYR</basicUdiDi>
    <tradeName>UROMED</tradeName>
    <deviceName>Stone Retrieval Basket (Stainless Steel/Nitinol)</deviceName>
    <manufacturerName>MANISH MEDI INNOVATION PRIVATE LIMITED</manufacturerName>
    <manufacturerSrn>IN-MF-000039093</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U090101</emdnCode>
    <emdnDescription>URINARY STONE RETRIEVAL BASKETS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SBN301100T</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-31T21:27:24.300Z</lastUpdated>
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