Xenta Biomedical Science Co., Ltd.

Active in EUDAMED

Chinafrom 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.

Catalogue135

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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: [email protected]
Phone: +86 20 3170 7187
PRRC contact: Han Zhang(public in EUDAMED)

Xenta Biomedical Science Co., Ltd.

What Xenta Biomedical Science Co., Ltd. makes

Catalogue135

Cardiac Troponin I (cTnI) Rapid Quantitative Test Ref XRDL096A105OS

Plasminogen (PLG) Rapid Quantitative Test Ref XRDL076A120OS

Cystatin C (Cys-C) Rapid Quantitative Test Ref XRDL083A120OS

Pepsinogen Ⅰ (PGⅠ) Rapid Quantitative Test Ref XRDL068A120OS

Tissue-Type Plasminogen Activator Inhibitor-1 Complex (t-PAIC) Rapid Quantitative Test Ref XRDL075A120OS

Luteinizing Hormone (LH) Rapid Quantitative Test Ref XRDL032A120OS

Cardiac Troponin I (cTnI) Rapid Quantitative Test Ref XRDL096A120OS

Neuron-Speciﬁc Enolase (NSE) Rapid Quantitative Test Ref XRDL043A120OS

Carcinoembryonic Antigen (CEA) Rapid Quantitative Test Ref XRDL019A105OS

Pepsinogen Ⅰ (PGⅠ) Rapid Quantitative Test Ref XRDL068A105OS

Protein Induced by Vitamin K Absence or Antagonist-Ⅱ (PIVKA-Ⅱ) Rapid Quantitative Test Ref XRDL054A105OS

Total Thyroxine (TT4) Rapid Quantitative Test Ref XRDL027A120OS

Luteinizing Hormone (LH) Rapid Quantitative Test Ref XRDL032A105OS

Pepsinogen Ⅱ (PGⅡ) Rapid Quantitative Test Ref XRDL069A120OS

Fibrin and Fibrinogen Degradation Products (FDP) Rapid Quantitative Test Ref XRDL071A105OS

Vitamin B12 (VB12) Rapid Quantitative Test Ref XRDL016A120OS

Free Triiodothyronine (FT3) Rapid Quantitative Test Ref XRDL025A105OS

Human Epididymis Protein 4 (HE4) Rapid Quantitative Test Ref XRDL052A105OS

Gastrin 17 (G-17) Rapid Quantitative Test Ref XRDL040A105OS

Anti-Mullerian Hormone (AMH) Rapid Quantitative Test Ref XRDL034A120OS

Myoglobin (Myo) Rapid Quantitative Test Ref XRDL006A105OS

Growth Diﬀerentiation Factor 15 (GDF-15) Rapid Quantitative Test Ref XRDL082A105OS

Creatine Kinase MB (CK-MB) Rapid Quantitative Test Ref XRDL005A120OS

C-Reactive Protein (CRP) Rapid Quantitative Test Ref XRDL037A105OS

Chitinase 3-Like Protein 1 (CHI3L1) Rapid Quantitative Test Ref XRDL078A105OS

Total IgE (tIgE) Rapid Quantitative Test Ref XRDL079A105OS

D-Dimer Rapid Quantitative Test Ref XRDL007A105OS

Cardiac Troponin T (cTnT) Rapid Quantitative Test Ref XRDL097A105OS

Heparin-Binding Protein (HBP) Rapid Quantitative Test Ref XRDL070A105OS

Plasmin-α2-Plasmin Inhibitor Complex (PIC) Rapid Quantitative Test Ref XRDL074A120OS

Growth Diﬀerentiation Factor 15 (GDF-15) Rapid Quantitative Test Ref XRDL082A120OS

Lipoprotein-Associated Phospholipase A2 (Lp-PLA2) Rapid Quantitative Test Ref XRDL008A120OS

Human β Amyloid 1-42 (Aβ1-42) Rapid Quantitative Test Ref XRDL059A105OS

Xenta Drug Screen Cup, Xenta Drug Screen Dipcard Ref K231137

Xenta Drug Screen Cup, Xenta Drug Screen Dipcard Ref K222955

Company details