08057920720893 8057920MICANTDISCHILL ESBL DISC Microbiol S.r.l. IT-MF-000052547 IVD Sınıf A IVDR 2017/746 W0104080502 IMPREGNATED DISKS, MULTI-DISKS & TABLETS Piyasada MICESBL-1K 2026-07-13T19:59:52.961Z 08057920720909 8057920MICANTDISCHILL Oxidase Test Microbiol S.r.l. IT-MF-000052547 IVD Sınıf A IVDR 2017/746 W0104080502 IMPREGNATED DISKS, MULTI-DISKS & TABLETS Piyasada O.80260 2026-07-13T19:59:52.494Z D-C79389Y6 B-C79389Y6 MicroScan Neg Combo 97 MicroScan Neg Combo 97 Beckman Coulter Inc. US-MF-000010288 Beckman Coulter Ireland Inc. IE-AR-000000886 IVD Genel IVDD W0104080101 GRAM NEGATIVE IDENTIFICATION - AUTOMATED Piyasada C79389 Ireland 2026-07-13T00:54:07.531Z D-C79387Y2 B-C79387Y2 MicroScan Neg Urine Combo 95 MicroScan Neg Urine Combo 95 Beckman Coulter Inc. US-MF-000010288 Beckman Coulter Ireland Inc. IE-AR-000000886 IVD Genel IVDD W0104080101 GRAM NEGATIVE IDENTIFICATION - AUTOMATED Piyasada C79387 Ireland 2026-07-13T00:54:06.734Z D-C63726WD B-C63726WD MicroScan Neg MIC 61 MicroScan Neg MIC 61 Beckman Coulter Inc. US-MF-000010288 Beckman Coulter Ireland Inc. IE-AR-000000886 IVD Genel IVDD W0104080101 GRAM NEGATIVE IDENTIFICATION - AUTOMATED Piyasada C63726 Ireland 2026-07-13T00:54:01.127Z D-C58012VP B-C58012VP MicroScan Neg MIC 57 MicroScan Neg MIC 57 Beckman Coulter Inc. US-MF-000010288 Beckman Coulter Ireland Inc. IE-AR-000000886 IVD Genel IVDD W0104080101 GRAM NEGATIVE IDENTIFICATION - AUTOMATED Piyasada C58012 Ireland 2026-07-13T00:54:00.328Z D-888501395SSAvanABT3Q B-888501395SSAvanABT3Q Sentosa SA vanA/vanB PCR Test Sentosa SA vanA/vanB PCR Test Vela Operations Singapore Pte. Ltd. SG-MF-000025684 Vela Diagnostics Germany GmbH DE-AR-000016088 IVD Genel IVDD W0104080604 NUCLEIC ACID IDENTIFICATION - MANUAL / AUTOMATED VRE Piyasada 300015, 300016 Germany 2026-07-12T17:29:39.060Z D-8683079717486E6 B-8683079717486E6 RevoDx Carbapenem resistance (blaNDM, blaKPC, blaIMP, blaOXA48, blaVIM) qPCR Kit RevoDx Carbapenem resistance (blaNDM, blaKPC, blaIMP, blaOXA48, blaVIM) qPCR Kit İDİL BİOTECH ARAŞTIRMA SAN. VE TİC. LTD. ŞTİ. TR-MF-000047330 IVD Genel IVDD W0104080606 NUCLEIC ACID IDENTIFICATION - MANUAL / AUTOMATED CARBAPENEMASE Piyasada IP202207-100 Italy 2026-07-12T13:23:30.072Z 16972698601443 B-16972698601443 Carbapenemase Rapid Test Carbapenemase Rapid Test Hangzhou Genesis Biodetection and Biocontrol Co., Ltd. CN-MF-000013495 CMC Medical Devices & Drugs SL ES-AR-000000293 IVD Genel IVDD W0104080506 TARGETED RESISTANCE TESTS - CARBAPENEMASE Piyasada P261102 Spain 2026-07-11T06:52:26.763Z 16972698601238 B-16972698601238 MCR-1 Enzyme Rapid Test MCR-1 Enzyme Rapid Test Hangzhou Genesis Biodetection and Biocontrol Co., Ltd. CN-MF-000013495 CMC Medical Devices & Drugs SL ES-AR-000000293 IVD Genel IVDD W0104080590 TARGETED RESISTANCE TESTS - OTHER Piyasada P261105 Spain 2026-07-11T06:52:05.923Z 16972698601221 B-16972698601221 CTX-M β-lactamases Rapid Test CTX-M β-lactamases Rapid Test Hangzhou Genesis Biodetection and Biocontrol Co., Ltd. CN-MF-000013495 CMC Medical Devices & Drugs SL ES-AR-000000293 IVD Genel IVDD W0104080505 TARGETED RESISTANCE TESTS - ESBL Piyasada P261104 Spain 2026-07-11T06:52:01.921Z 16972698601214 B-16972698601214 OXA-23 Carbapenemase Rapid Test OXA-23 Carbapenemase Rapid Test Hangzhou Genesis Biodetection and Biocontrol Co., Ltd. CN-MF-000013495 CMC Medical Devices & Drugs SL ES-AR-000000293 IVD Genel IVDD W0104080506 TARGETED RESISTANCE TESTS - CARBAPENEMASE Piyasada P261103 Spain 2026-07-11T06:52:01.136Z 16972698601061 B-16972698601061 GBS Screen Broth Hangzhou Genesis Biodetection and Biocontrol Co., Ltd. CN-MF-000013495 Lotus NL B.V. NL-AR-000000121 IVD Genel IVDD W0104080203 GRAM POSITIVE - MANUAL IDENTIFICATION Piyasada M131002 Netherlands 2026-07-11T06:51:54.722Z 16972698601054 B-16972698601054 GBS Screen Broth Hangzhou Genesis Biodetection and Biocontrol Co., Ltd. CN-MF-000013495 Lotus NL B.V. NL-AR-000000121 IVD Genel IVDD W0104080203 GRAM POSITIVE - MANUAL IDENTIFICATION Piyasada M131001 Netherlands 2026-07-11T06:51:53.918Z 15420071901006 B-15420071901006 RESIST-1 MCR Multi Mobilised colistin resistance rapid test RESIST-1 MCR Multi Mobilised colistin resistance rapid test Coris BioConcept BE-MF-000024520 IVD Genel IVDD W0104080590 TARGETED RESISTANCE TESTS - OTHER Piyasada K-13R15 Belgium 2026-07-11T05:44:14.411Z 15420071900993 B-15420071900993 RESIST-1 MCR Multi Mobilised colistin resistance rapid test RESIST-1 MCR Multi Mobilised colistin resistance rapid test Coris BioConcept BE-MF-000024520 IVD Genel IVDD W0104080590 TARGETED RESISTANCE TESTS - OTHER Piyasada K-15R15 Belgium 2026-07-11T05:44:13.606Z 15065023763389 B-15065023763389 TruVue Carbapenem Resistant Enterobacteriaceae assay (LFA) BioFynder Limited UK-MF-000047512 SUNGO Europe B.V. 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