| Protin induced by Vitamin K Absence or Antagonist -Ⅱ(PIVKA-Ⅱ)Assay Reagent Kit (CMIA) | C2KH014 | EUDAMED | IVD General | Active |
| Gonorrhea Rapid Test Device (Swab) | C061301D | EUDAMED | IVD General | Active |
| Myoglobin (MYO) Assay Reagent Kit (CMIA) | C2KL007 | EUDAMED | IVD General | Active |
| 25-Hydroxy Vitamin D (25-OH VD) Assay Reagent Kit (CMIA) | C2KA004 | EUDAMED | IVD General | Active |
| Neuron-Specific Enolase (NSE) Assay Reagent Kit (CMIA) | C2H003 | EUDAMED | IVD General | Active |
| 2019-nCOV IgGIgM Rapid Test Device (whole blood/serum/plasma) | A190501D | EUDAMED | IVD General | Active |
| LH Rapid Test Device(urine) | C110301D | EUDAMED | IVD General | Active |
| Estradiol (E2) Assay Reagent Kit (CMIA) | C2KJ011 | EUDAMED | IVD General | Active |
| Carbohydrate antigen 242 Assay Reagent Kit (CMIA) | C2KH0111 | EUDAMED | IVD General | Active |
| Myoglobin Rapid Test Device (Whole Blood/Serum/Plasma) | J040501D | EUDAMED | IVD General | Active |
| Buprenorph (BUP) Assay Reagent Kit (CMIA) | C2KG008 | EUDAMED | IVD General | Active |
| Procalcitonin Rapid Test Device (serum/plasma) | H021401D | EUDAMED | IVD General | Active |
| CK-MB Rapid Test Device (Whole Blood/Serum/Plasma) | J020501D | EUDAMED | IVD General | Active |
| C-reactive Protein Rapid Test Device (whole blood/serum/plasma) | H010501D | EUDAMED | IVD General | Active |
| hCG Rapid Test Device(urine) | C100301D | EUDAMED | IVD General | Active |
| HAV IgGIgM Rapid Test Device(Serum/Plasma) | A341401D | EUDAMED | IVD General | Active |
| Transferrin Rapid Test Device (feces) | D010401D | EUDAMED | IVD General | Active |
| S.typhi Antigen Rapid Test Device (feces) | A090401D | EUDAMED | IVD General | Active |
| Osteocalcin Assay Reagent Kit (CMIA) | C2KA003 | EUDAMED | IVD General | Active |
| Novel Coronavirus (COVID-19)Antigen Rapid Test Device(swab) | A010101D | EUDAMED | IVD General | Active |
| IgE Rapid Test Device (whole blood/serum/plasma) | D020501D | EUDAMED | IVD General | Active |
| Human Monkeypox Virus (MPV) Antigen Rapid Test Device (Colloidal Gold) | A051601D | EUDAMED | IVD General | Active |
| -reactive Protein Semi-quantitative Rapid Test Device (Whole blood/Serum/Plasma) | H110516D | EUDAMED | IVD General | Active |
| High Sensitivity Cardiac Troponin I Rapid Test Device (whole blood/serum/plasma) | E020501D | EUDAMED | IVD General | Active |
| RSV Rapid Test Device (Swab) | A431301D | EUDAMED | IVD General | Active |
| Thyroglobulin (TG) Assay Reagent Kit (CMIA) | C2KI003 | EUDAMED | IVD General | Active |
| Morphine(MOP)Assay Reagent Kit (CMIA) | C2KG011 | EUDAMED | IVD General | Active |
| Mycoplasma pneumoniae IgM antibody Assay Reagent Kit (CMIA) | C2KC005 | EUDAMED | IVD General | Active |
| Total T4 (TT4) Assay Reagent Kit (CMIA) | C2KI008 | EUDAMED | IVD General | Active |
| Total Immunoglobulin E (Total IgE) Assay Reagent Kit (CMIA) | C2KF001 | EUDAMED | IVD General | Active |
| Follicle-Stimulating Hormone (FSH) Assay Reagent Kit (CMIA) | C2KJ012 | EUDAMED | IVD General | Active |
| Malaria P.f. Rapid Test Device (whole blood) | A270901D | EUDAMED | IVD General | Active |
| M.Pneumonia Antigen Rapid Test Device (swab) | D020501D | EUDAMED | IVD General | Active |
| Typhoid IgG/IgM Rapid Test (Serum/Plasma) | A471401T | EUDAMED | IVD General | Active |
| Folate Assay Reagent Kit (CMIA) | C2KK001 | EUDAMED | IVD General | Active |
| Infectious Mononucleosis Igm Rapid Test Device(Whole Blood/Serum/Plasma) | A410501D | EUDAMED | IVD General | Active |
| Myeloperoxidase (MPO) Assay Reagent Kit (CMIA) | C2KL003 | EUDAMED | IVD General | Active |
| LH Rapid Test (urine) | C030301D | EUDAMED | IVD General | Active |
| Progesterone (PROG) Assay Reagent Kit(CMIA) | C2KJ013 | EUDAMED | IVD General | Active |
| hCG Rapid Test Device( serum/plasma) | C081401D | EUDAMED | IVD General | Active |
| Marijuana (THC) Assay Reagent Kit (CMIA) | C2KG002 | EUDAMED | IVD General | Active |
| NT-proBNP Rapid Test Device (plasma/Serum) | B011401D | EUDAMED | IVD General | Active |
| Herpes Simplex Virus -Ⅰ IgG (HSV-Ⅰ IgG) Assay Reagent Kit (CMIA) | C2KE001 | EUDAMED | IVD General | Active |
| Squamous Cell Carcinoma Antigen (SCCA) Assay Reagent Kit (CMIA) | C2KH007 | EUDAMED | IVD General | Active |
| Human Growth Hormone (hGH) Assay Reagent Kit (CMIA) | C2KA002 | EUDAMED | IVD General | Active |
| Pepsinogen I (PG I) Assay Reagent Kit (CMIA) | C2KH004 | EUDAMED | IVD General | Active |
| Human Chorionic Gonadotropin (HCG) Assay Reagent Kit (CMIA) | C2KJ001 | EUDAMED | IVD General | Active |
| Tissue polypeptide antigen(TPA) Assay Reagent Kit (CMIA) | C2KH016 | EUDAMED | IVD General | Active |
| HAV IgM Rapid Test Device(Serum/Plasma) | A531401D | EUDAMED | IVD General | Active |
| Typhoid IgGIgM Rapid Test Device (serum/plasma/whole blood) | A310501D | EUDAMED | IVD General | Active |