Xenta Biomedical Science Co., Ltd.
Active in EUDAMEDChinafrom SRN EUDAMED SRN CN-MF-000057746
- Devices
- 135
- Registrations
- EUDAMED
What Xenta Biomedical Science Co., Ltd. makes
Xenta Biomedical Science Co., Ltd. manufactures rapid drug screening devices, including the Xenta Drug Screen Cup and Xenta Drug Screen Dipcard, designed for detecting the presence of drugs in biological samples.
These devices are classified as Class II under FDA regulations and are listed via the 510(k) pathway. The company is based in the United States.
AI-generated from registry data, 3 Oct 2026. Not verified by deviCERTS or the manufacturer.
DeviceDevice · Authorizations Verified Status Regime Registry Class
Plasminogen (PLG) Rapid Quantitative Test Ref XRDL076A105OS
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD GeneralTotal IgE (tIgE) Rapid Quantitative Test Ref XRDL079A120OS
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD GeneralMyeloperoxidase (MPO) Rapid Quantitative Test Ref XRDL009A105OS
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD GeneralGlycosylated Hemoglobin A1c (HbA1c) Rapid Quantitative Test Ref XRDL018A120OS
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD GeneralProtein Induced by Vitamin K Absence or Antagonist-Ⅱ (PIVKA-Ⅱ) Rapid Quantitative Test Ref XRDL054A120OS
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD GeneralProcalcitonin (PCT) Rapid Quantitative Test Ref XRDL036A120OS
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD GeneralCentral Nervous System Specific Protein (S100-β) Rapid Quantitative Test Ref XRDL011A120OS
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD GeneralNeurofilament Light Chain Protein (NFL) Rapid Quantitative Test Ref XRDL066A105OS
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD GeneralTB Specific Cellular Immune Response (TB-IGRA) Rapid Quantitative Test Ref XRDL041A120OS
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD GeneralVitamin B12 (VB12) Rapid Quantitative Test Ref XRDL016A105OS
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD GeneralHeparin-Binding Protein (HBP) Rapid Quantitative Test Ref XRDL070A120OS
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD GeneralD-Dimer Rapid Quantitative Test Ref XRDL007A120OS
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD GeneralTissue-Type Plasminogen Activator Inhibitor-1 Complex (t-PAIC) Rapid Quantitative Test Ref XRDL075A105OS
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD GeneralPhosphorylation of Tau217 (p-Tau217) Rapid Quantitative Test Ref XRDL063A105OS
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD GeneralGlial Fibrillary Acidic Protein (GFAP) Rapid Quantitative Test Ref XRDL061A120OS
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD GeneralHeart-Type Fatty Acid Binding Protein (H-FABP) Rapid Quantitative Test Ref XRDL013A120OS
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD GeneralGastrin 17 (G-17) Rapid Quantitative Test Ref XRDL040A120OS
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD GeneralHuman Epididymis Protein 4 (HE4) Rapid Quantitative Test Ref XRDL052A120OS
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD GeneralThyroid Stimulating Hormone (TSH) Rapid Quantitative Test Ref XRDL023A120OS
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD GeneralAlpha-fetoprotein (AFP) Rapid Quantitative Test Ref XRDL022A120OS
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD GeneralFollicle Stimulating Hormone (FSH) Rapid Quantitative Test Ref XRDL033A105OS
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD GeneralThyroid Stimulating Hormone (TSH) Rapid Quantitative Test Ref XRDL023A105OS
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD GeneralKrebs von den Lungen-6 (KL-6) Rapid Quantitative Test Ref XRDL081A105OS
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD GeneralSerum Amyloid A (SAA) Rapid Quantitative Test Ref XRDL039A120OS
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD General- Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD General
High Sensitive Cardiac Troponin I (hs-cTnI) Rapid Quantitative Test Ref XRDL001A120OS
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD GeneralBrain Natriuretic Peptide (BNP) Rapid Quantitative Test Ref XRDL003A105OS
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD GeneralInhibin B (INH-B) Rapid Quantitative Test Ref XRDL035A105OS
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD GeneralHeart-Type Fatty Acid Binding Protein (H-FABP) Rapid Quantitative Test Ref XRDL013A105OS
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD GeneralGlycosylated Hemoglobin A1c (HbA1c) Rapid Quantitative Test Ref XRDL018A105OS
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD GeneralVascular Endothelial Growth Factor (VEGF) Rapid Quantitative Test Ref XRDL080A120OS
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD GeneralTotal Triiodothyronine (TT3) Rapid Quantitative Test Ref XRDL024A105OS
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD GeneralMicroalbumin (MAU) Rapid Quantitative Test Ref XRDL017A105OS
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD GeneralHigh Sensitive Cardiac Troponin T (hs-cTnT) Rapid Quantitative Test Ref XRDL002A120OS
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD GeneralFolic Acid (FA) Rapid Quantitative Test Ref XRDL042A120OS
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD GeneralFree Thyroxine (FT4) Rapid Quantitative Test Ref XRDL026A105OS
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD GeneralCreatine Kinase MB (CK-MB) Rapid Quantitative Test Ref XRDL005A105OS
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD GeneralProlactin (PRL) Rapid Quantitative Test Ref XRDL031A120OS
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD GeneralMicroalbumin (MAU) Rapid Quantitative Test Ref XRDL017A120OS
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD GeneralMyeloperoxidase (MPO) Rapid Quantitative Test Ref XRDL009A120OS
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD GeneralNeurofilament Light Chain Protein (NFL) Rapid Quantitative Test Ref XRDL066A120OS
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD GeneralCentral Nervous System Specific Protein (S100-β) Rapid Quantitative Test Ref XRDL011A105OS
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD GeneralAnti-Mullerian Hormone (AMH) Rapid Quantitative Test Ref XRDL034A105OS
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD GeneralCardiac Troponin T (cTnT) Rapid Quantitative Test Ref XRDL097A120OS
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD GeneralMyoglobin (Myo) Rapid Quantitative Test Ref XRDL006A120OS
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD GeneralFollicle Stimulating Hormone (FSH) Rapid Quantitative Test Ref XRDL033A120OS
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD GeneralHomocysteine (HCY) Rapid Quantitative Test Ref XRDL010A120OS
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD GeneralThrombin-Antithrombin Ⅲ Complex (TAT) Rapid Quantitative Test Ref XRDL073A105OS
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD GeneralVitamin D (25-OH-VD) Rapid Quantitative Test Ref XRDL015A105OS
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD GeneralPlasmin-α2-Plasmin Inhibitor Complex (PIC) Rapid Quantitative Test Ref XRDL074A105OS
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD General
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Company details
- EUDAMED SRN
- CN-MF-000057746
- EU VAT number
- 91440101MA9Y8NRJ81
- EUDAMED status
- Active
- EUDAMED registered name
- Xenta Biomedical Science Co., Ltd.
- EUDAMED abbreviated name
- Xenta
- Registered address
- No. 11, Kaiyuan Avenue, 510535, Guangzhou, China
- Website
- www.xentabms.com
- [email protected]
- Phone
- +86 20 3170 7187
- PRRC contact
- Han Zhang(public in EUDAMED)