03573026621377 357302BUDI002012SX VITEK® 2 AST-N405 VITEK® 2 AST-N405 bioMérieux, Inc. US-MF-000011802 bioMérieux SA FR-AR-000004435 IVD Sınıf B IVDR 2017/746 W0104080107 GRAM NEGATIVE SUSCEPTIBILITY TESTING - AUTOMATED Piyasada 542854 France 2026-07-21T19:52:29.188Z 03573026612276 357302BUDI000660TS VITEK® 2 AST-N391 VITEK® 2 AST-N391 bioMérieux, Inc. US-MF-000011802 bioMérieux SA FR-AR-000004435 IVD Sınıf B IVDR 2017/746 W0104080107 GRAM NEGATIVE SUSCEPTIBILITY TESTING - AUTOMATED Piyasada 542510 France 2026-07-21T19:52:23.590Z 03573026612252 357302BUDI000659U9 VITEK® 2 AST-N390 VITEK® 2 AST-N390 bioMérieux, Inc. US-MF-000011802 bioMérieux SA FR-AR-000004435 IVD Sınıf B IVDR 2017/746 W0104080107 GRAM NEGATIVE SUSCEPTIBILITY TESTING - AUTOMATED Piyasada 542509 France 2026-07-21T19:52:22.807Z 03573026584146 357302BUDI000278TR KOVACS KOVACS bioMérieux SA FR-MF-000004436 IVD Sınıf A IVDR 2017/746 W0104080299 MANUAL IDENTIFICATION - OTHER Piyasada 540610 France 2026-07-21T19:50:55.440Z 03573026550592 357302BUDI000730TN ETEST® Ceftolozane/Tazobactam (C/T) ETEST® Ceftolozane/Tazobactam (C/T) bioMérieux SA FR-MF-000004436 IVD Sınıf B IVDR 2017/746 W0104080501 MIC SYSTEMS - DILUTION METHODS (INCL. E-TEST) Piyasada 8309016 France 2026-07-21T19:50:54.639Z 03573026550455 357302BUDI000734TW ETEST® Metronidazole (MZ) ETEST® Metronidazole (MZ) bioMérieux SA FR-MF-000004436 IVD Sınıf B IVDR 2017/746 W0104080501 MIC SYSTEMS - DILUTION METHODS (INCL. E-TEST) Piyasada 8309002 France 2026-07-21T19:50:49.837Z 03573026549992 357302BUDI000621TG ETEST® Cefepime (PM) ETEST® Cefepime (PM) bioMérieux SA FR-MF-000004436 IVD Sınıf B IVDR 2017/746 W0104080501 MIC SYSTEMS - DILUTION METHODS (INCL. E-TEST) Piyasada 8308956 France 2026-07-21T19:50:49.037Z 05056080500508 50560805WCSalmonellaNB Wellcolex Colour Salmonella (200 tests) Remel Europe Ltd GB-MF-000016733 Thermo Fisher Diagnostics B.V. NL-AR-000013157 IVD Sınıf B UNKNOWN W0104080301 SEROTYPING (E.COLI, SALMONELLA, SHIGELLA, ETC) Piyasada R30858302 Netherlands 2026-07-20T08:27:16.884Z 05056080501505 50560805StapharexLD Staphaurex Latex Agglutination Test (400 Tests) Remel Europe Ltd GB-MF-000016733 Thermo Fisher Diagnostics B.V. NL-AR-000013157 IVD Sınıf B UNKNOWN W0104080303 STAPHYLOCOCCI SLIDE TESTS Piyasada R30859902 Netherlands 2026-07-20T08:27:16.141Z 05056080501529 50560805StapharexPlusC6 Staphaurex Plus Latex Agglutination Test (450 tests) Remel Europe Ltd GB-MF-000016733 Thermo Fisher Diagnostics B.V. NL-AR-000013157 IVD Sınıf B UNKNOWN W0104080303 STAPHYLOCOCCI SLIDE TESTS Piyasada R30950201 2026-07-20T08:27:16.069Z 16975631347026 697563134KM007G4 16975631347026 JIANGSU COMEON MEDICAL APPARATUS CO., LTD CN-MF-000018384 Sungo Cert GmbH DE-AR-000010869 IVD Sınıf A UNKNOWN W0104080604 NUCLEIC ACID IDENTIFICATION - MANUAL / AUTOMATED VRE Piyasada N/A 2026-07-19T06:16:34.514Z 06975514361036 697551436BFMP001NK 06975514361036 DNA/RNA Extraction/Purification Kit Hangzhou Bigfish Bio-tech Co., Ltd. CN-MF-000027212 SUNGO Europe B.V. NL-AR-000000247 IVD Sınıf A IVDR 2017/746 W0104080699 NUCLEIC ACID IDENTIFICATION (BACTERIOLOGY) MANUAL / AUTOMATED - OTHER Piyasada BFMP09R96 Italy 2026-07-17T21:09:31.978Z 06975514361029 697551436BFMP001NK 06975514361029 DNA/RNA Extraction/Purification Kit Hangzhou Bigfish Bio-tech Co., Ltd. CN-MF-000027212 SUNGO Europe B.V. NL-AR-000000247 IVD Sınıf A IVDR 2017/746 W0104080699 NUCLEIC ACID IDENTIFICATION (BACTERIOLOGY) MANUAL / AUTOMATED - OTHER Piyasada BFMP07R96 Italy 2026-07-17T21:06:02.343Z 06975514360992 697551436BFMP001NK 06975514360992 DNA/RNA Extraction/Purification Kit Hangzhou Bigfish Bio-tech Co., Ltd. CN-MF-000027212 SUNGO Europe B.V. NL-AR-000000247 IVD Sınıf A IVDR 2017/746 W0104080699 NUCLEIC ACID IDENTIFICATION (BACTERIOLOGY) MANUAL / AUTOMATED - OTHER Piyasada BFMP03R96 Italy 2026-07-17T21:03:32.045Z 06975514360985 697551436BFMP001NK 06975514360985 DNA/RNA Extraction/Purification Kit Hangzhou Bigfish Bio-tech Co., Ltd. CN-MF-000027212 SUNGO Europe B.V. NL-AR-000000247 IVD Sınıf A IVDR 2017/746 W0104080699 NUCLEIC ACID IDENTIFICATION (BACTERIOLOGY) MANUAL / AUTOMATED - OTHER Piyasada BFMP01R96 Italy 2026-07-17T21:00:01.783Z 06975514360978 697551436BFMP001NK 06975514360978 DNA/RNA Extraction/Purification Kit Hangzhou Bigfish Bio-tech Co., Ltd. CN-MF-000027212 SUNGO Europe B.V. NL-AR-000000247 IVD Sınıf A IVDR 2017/746 W0104080699 NUCLEIC ACID IDENTIFICATION (BACTERIOLOGY) MANUAL / AUTOMATED - OTHER Piyasada BFMP09R1 Italy 2026-07-17T20:57:38.562Z 06975514360961 697551436BFMP001NK 06975514360961 DNA/RNA Extraction/Purification Kit Hangzhou Bigfish Bio-tech Co., Ltd. CN-MF-000027212 SUNGO Europe B.V. NL-AR-000000247 IVD Sınıf A IVDR 2017/746 W0104080699 NUCLEIC ACID IDENTIFICATION (BACTERIOLOGY) MANUAL / AUTOMATED - OTHER Piyasada BFMP07R1 Italy 2026-07-17T20:49:30.305Z D-211045-20-061CQ B-211045-20-061CQ KPC/IMP/NDM/VIM/OXA-48 Combo Test Kit (LFIA) KPC/IMP/NDM/VIM/OXA-48 Combo Test Kit (LFIA) Jiangsu Medomics Medical Technology Co.,Ltd. CN-MF-000030226 R Sight B.V. NL-AR-000010445 IVD Genel IVDD W0104080506 TARGETED RESISTANCE TESTS - CARBAPENEMASE Piyasada 211045-20-061 Poland 2026-07-16T22:49:45.821Z D-211045-01-061C9 B-211045-01-061C9 KPC/IMP/NDM/VIM/OXA-48 Combo Test Kit (LFIA) KPC/IMP/NDM/VIM/OXA-48 Combo Test Kit (LFIA) Jiangsu Medomics Medical Technology Co.,Ltd. CN-MF-000030226 R Sight B.V. NL-AR-000010445 IVD Genel IVDD W0104080506 TARGETED RESISTANCE TESTS - CARBAPENEMASE Piyasada 211045-01-061 Poland 2026-07-16T22:49:45.015Z 07332940006525 B-07332940006525 Xpert® Xpert® Carba-R Cepheid US-MF-000010979 Cepheid AB SE-AR-000048904 IVD Genel IVDD W0104080606 NUCLEIC ACID IDENTIFICATION - MANUAL / AUTOMATED CARBAPENEMASE Piyasada GXCARBARP-CE-120 Netherlands 2026-07-16T16:56:00.543Z