D-GCMP(IgM)-302aHGWR B-GCMP(IgM)-302aHGWR M. pneumonia IgM Rapid Test Cassette (Serum/Plasma) M. pneumonia IgM Rapid Test Cassette (Serum/Plasma) Healgen Scientific Limited Liability Company US-MF-000018839 CMC Medical Devices & Drugs SL ES-AR-000000293 IVD Genel IVDD W0105010802 MYCOPLASMA ANTIBODY ASSAYS Piyasada GCMP(IgM)-302a Germany 2026-07-13T21:29:45.942Z D-GCLEP(IgG/IgM)-402aRF B-GCLEP(IgG/IgM)-402aRF Leptospira IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) Leptospira IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) Zhejiang Orient Gene Biotech Co., Ltd CN-MF-000017965 CMC Medical Devices & Drugs SL ES-AR-000000293 IVD Genel IVDD W0105011704 LEPTOSPIRA Piyasada GCLEP(IgG/IgM)-402a Germany 2026-07-13T21:28:56.354Z D-GCLEP(IgG/IgM)-402aHG8L B-GCLEP(IgG/IgM)-402aHG8L Leptospira IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) Leptospira IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) Healgen Scientific Limited Liability Company US-MF-000018839 CMC Medical Devices & Drugs SL ES-AR-000000293 IVD Genel IVDD W0105011704 LEPTOSPIRA Piyasada GCLEP(IgG/IgM)-402a Germany 2026-07-13T21:28:52.346Z D-GCHP-606aZP B-GCHP-606aZP H.pylori Ag Rapid Test Device (Feces) H.pylori Ag Rapid Test Device (Feces) Zhejiang Orient Gene Biotech Co., Ltd CN-MF-000017965 CMC Medical Devices & Drugs SL ES-AR-000000293 IVD Genel IVDD W0105010401 H. PYLORI ANTIGEN DETECTION Piyasada GCHP-606a Germany 2026-07-13T21:28:19.016Z D-GCHP-602CJ B-GCHP-602CJ H. pylori Ag Rapid Test Cassette (Feces) H. pylori Ag Rapid Test Cassette (Feces) Zhejiang Orient Gene Biotech Co., Ltd CN-MF-000017965 CMC Medical Devices & Drugs SL ES-AR-000000293 IVD Genel IVDD W0105010401 H. PYLORI ANTIGEN DETECTION Piyasada GCHP-602a，GCHP-602Ca Germany 2026-07-13T21:28:11.496Z D-GCHP-601CG B-GCHP-601CG H. pylori Ag Rapid Test Strip (Feces) H. pylori Ag Rapid Test Strip (Feces) Zhejiang Orient Gene Biotech Co., Ltd CN-MF-000017965 CMC Medical Devices & Drugs SL ES-AR-000000293 IVD Genel IVDD W0105010401 H. PYLORI ANTIGEN DETECTION Piyasada GCHP-601a，GCHP-601Ca Germany 2026-07-13T21:27:52.254Z D-GCHP-402aYV B-GCHP-402aYV H. pylori Ab Rapid Test Cassette (Whole blood/Serum/Plasma) H. pylori Ab Rapid Test Cassette (Whole blood/Serum/Plasma) Zhejiang Orient Gene Biotech Co., Ltd CN-MF-000017965 Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001 IVD Genel IVDD W0105010402 H. PYLORI ANTIBODY ASSAYS Piyasada GCHP-402a Germany 2026-07-13T21:27:50.718Z D-GCHP-401aYS B-GCHP-401aYS H. pylori Ab Rapid Test Strip (Whole blood/Serum/Plasma) H. pylori Ab Rapid Test Strip (Whole blood/Serum/Plasma) Zhejiang Orient Gene Biotech Co., Ltd CN-MF-000017965 Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001 IVD Genel IVDD W0105010402 H. PYLORI ANTIBODY ASSAYS Piyasada GCHP-401a Germany 2026-07-13T21:27:48.239Z D-GCHP-302aYN B-GCHP-302aYN H. pylori Ab Rapid Test Cassette (Serum/Plasma) H. pylori Ab Rapid Test Cassette (Serum/Plasma) Zhejiang Orient Gene Biotech Co., Ltd CN-MF-000017965 Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001 IVD Genel IVDD W0105010402 H. PYLORI ANTIBODY ASSAYS Piyasada GCHP-302a Germany 2026-07-13T21:27:44.240Z D-GCHP-301aYK B-GCHP-301aYK H. pylori Ab Rapid Test Strip (Serum/Plasma) H. pylori Ab Rapid Test Strip (Serum/Plasma) Zhejiang Orient Gene Biotech Co., Ltd CN-MF-000017965 Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001 IVD Genel IVDD W0105010402 H. PYLORI ANTIBODY ASSAYS Piyasada GCHP-301a Germany 2026-07-13T21:27:42.307Z D-GCGON-502bHG3H B-GCGON-502bHG3H Gonorrhea Rapid Test Cassette (Swab) Gonorrhea Rapid Test Cassette (Swab) Healgen Scientific Limited Liability Company US-MF-000018839 CMC Medical Devices & Drugs SL ES-AR-000000293 IVD Genel IVDD W0105010201 GONOCOCCAL ANTIGEN DETECTION Piyasada GCGON-502b Germany 2026-07-13T21:27:20.222Z D-GCGON-502b3G B-GCGON-502b3G Gonorrhea Rapid Test Cassette (Swab) Gonorrhea Rapid Test Cassette (Swab) Zhejiang Orient Gene Biotech Co., Ltd CN-MF-000017965 CMC Medical Devices & Drugs SL ES-AR-000000293 IVD Genel IVDD W0105010201 GONOCOCCAL ANTIGEN DETECTION Piyasada GCGON-502b Germany 2026-07-13T21:27:18.614Z D-GCCRE-T1402a25 B-GCCRE-T1402a25 CARBA 5 In 1 Rapid Test Cassette CARBA 5 In 1 Rapid Test Cassette Zhejiang Orient Gene Biotech Co., Ltd CN-MF-000017965 CMC Medical Devices & Drugs SL ES-AR-000000293 IVD Genel IVDD W0105011799 BACTERIOLOGY IMMUNOASSAY - OTHER Piyasada GCCRE-T1402a Germany 2026-07-13T21:25:27.915Z D-GCCHL-502aUE B-GCCHL-502aUE Chlamydia Trachomatis Antigen Rapid Test (Cassette) (Swab/Urine) Chlamydia Trachomatis Antigen Rapid Test Zhejiang Orient Gene Biotech Co., Ltd CN-MF-000017965 CMC Medical Devices & Drugs SL ES-AR-000000293 IVD Ek II Liste B IVDD W0105010107 CHLAMYDIA TRACHOMATIS ANTIGEN DETECTION Piyasada GCCHL-502a Germany 2026-07-13T21:23:39.183Z D-GCCD-602aRS B-GCCD-602aRS Clostridium difficile GDH & Toxin A/B Rapid Test Cassette (Feces) Clostridium difficile GDH & Toxin A/B Rapid Test Cassette (Feces) Zhejiang Orient Gene Biotech Co., Ltd CN-MF-000017965 CMC Medical Devices & Drugs SL ES-AR-000000293 IVD Genel IVDD W0105011803 C.DIFFICILE GDH AND TOXIN A/B COMBINED DETECTION Piyasada GCCD-602a Germany 2026-07-13T21:23:17.151Z D-GCCD(ToxinAB)-602aZC B-GCCD(ToxinAB)-602aZC Clostridium difficile Toxin A&B Rapid Test Casette (Feces) Clostridium difficile Toxin A&B Rapid Test Casette (Feces) Zhejiang Orient Gene Biotech Co., Ltd CN-MF-000017965 CMC Medical Devices & Drugs SL ES-AR-000000293 IVD Genel IVDD W0105011802 C.DIFFICILE TOXIN A/B DETECTION Piyasada GCCD(Toxin A/B)-602a Germany 2026-07-13T21:23:12.349Z D-GCBRU-402aHG4Q B-GCBRU-402aHG4Q Brucella Antibody Rapid Test Cassette (Whole Blood/Serum/Plasma) Brucella Antibody Rapid Test Cassette (Whole Blood/Serum/Plasma) Healgen Scientific Limited Liability Company US-MF-000018839 CMC Medical Devices & Drugs SL ES-AR-000000293 IVD Genel IVDD W0105011701 BRUCELLA Piyasada GCBRU-402a Germany 2026-07-13T21:23:05.941Z D-GCCD(GDH)-602aH3 B-GCCD(GDH)-602aH3 Clostridium difficile Antigen GDH Rapid Test Cassette (Feces) Clostridium difficile Antigen GDH Rapid Test Cassette (Feces) Zhejiang Orient Gene Biotech Co., Ltd CN-MF-000017965 CMC Medical Devices & Drugs SL ES-AR-000000293 IVD Genel IVDD W0105011801 C.DIFFICILE GDH DETECTION Piyasada GCCD(GDH)-602a Germany 2026-07-13T21:23:05.143Z D-GCBRU-402a4N B-GCBRU-402a4N Brucella Antibody Rapid Test Cassette (Whole Blood/Serum/Plasma) Brucella Antibody Rapid Test Cassette (Whole Blood/Serum/Plasma) Zhejiang Orient Gene Biotech Co., Ltd CN-MF-000017965 CMC Medical Devices & Drugs SL ES-AR-000000293 IVD Genel IVDD W0105011701 BRUCELLA Piyasada GCBRU-402a Germany 2026-07-13T21:22:47.494Z D-GCBRU(IgG/IgM)-402aHGMN B-GCBRU(IgG/IgM)-402aHGMN Brucella IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) Brucella IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) Healgen Scientific Limited Liability Company US-MF-000018839 CMC Medical Devices & Drugs SL ES-AR-000000293 IVD Genel IVDD W0105011701 BRUCELLA Piyasada GCBRU(IgG/IgM)-402a Germany 2026-07-13T21:22:46.690Z