Manufacturer

Xenta Biomedical Science

ChinaLegal entities : Xenta Biomedical Science Co., Ltd.

First countries of placing on the market declared in EUDAMED : Italy

EU representative : CMC Medical Devices & Drugs SL (Spain)

16 categories, 25 models including 25 on the market, 1 country

On the market
No longer marketed
93/42 Former directive, not yet certified under the MDR
Click a category to see competitors, a model to open its EUDAMED record.

Category	EMDN code	Registered models	Class	Contact
Coronavirus antigen (ag) - RT & POC	W0105090501	COVID-19 Antigen Rapid Detection Kit (Nasal Swab)2 refs98/79 COVID-19 Antigen Rapid Detection Kit (NP Swab)2 refs98/79 COVID-19 Antigen Rapid Detection Kit (Saliva Lollipop)2 refs98/79 COVID-19 Antigen Rapid Detection Kit (Saliva)2 refs98/79 COVID-19 Antigen Rapid Detection Kit (Throat Swab)2 refs98/79	– 98/79	EUDAMED record Report an error
D-dimer - RT & POC	W0103020803	D-Dimer Detection Kit (Fluorescent Immune Chromatography)2 refs98/79 D-Dimer Rapid Quantitative Test XRDL007A105OS98/79 D-Dimer Rapid Quantitative Test XRDL007A120OS98/79	– 98/79	EUDAMED record Report an error
Plasmodium (malaria) - RT & POC	W0105090401	Malaria Antigen P.f Detection Reagent (Colloidal Gold method)2 refs98/79 Malaria Antigen P.f/P.v Detection Reagent (Colloidal Gold method)2 refs98/79 Malaria Antigen P.f/Pan Detection Reagent (Colloidal Gold method)2 refs98/79	– 98/79	EUDAMED record Report an error
Interleukin 6 (il-6)	W01030609	IL-6 Detection Kit (Fluorescent Immune Chromatography)2 refs98/79 Interleukin-6 (IL-6) Rapid Quantitative Test2 refs98/79	– 98/79	EUDAMED record Report an error
Bacteriology - RT & POC - other	W0105090199	TB Specific Cellular Immune Response (TB-IGRA) Rapid Quantitative Test2 refs98/79	– 98/79	EUDAMED record Report an error
Coagulation inhibitors - other	W0103020699	Thrombomodulin (TM) Rapid Quantitative Test2 refs98/79	– 98/79	EUDAMED record Report an error
Coronavirus / influenza - RT & POC	W0105090601	IFA & IFB & COVID-19 Antigen Joint Detection Kit (Immunochromatography Assay)2 refs98/79	– 98/79	EUDAMED record Report an error
Fibrinogen degradation products	W0103020502	Fibrin and Fibrinogen Degradation Products (FDP) Rapid Quantitative Test2 refs98/79	– 98/79	EUDAMED record Report an error
Immunochemistry instruments - other	W02010299	Light-initiated Chemiluminescent Immunoanalyzer98/79	– 98/79	EUDAMED record Report an error
Influenza a and /or b - RT & POC	W0105099004	IFA & IFB Antigen Joint Detection Kit (Immunochromatography Assay)2 refs98/79	– 98/79	EUDAMED record Report an error
Plasmin - a2 - antiplasmin complex	W0103020305	Plasmin-α2-Plasmin Inhibitor Complex (PIC) Rapid Quantitative Test2 refs98/79	– 98/79	EUDAMED record Report an error
Plasminogen	W0103020505	Plasminogen (PLG) Rapid Quantitative Test2 refs98/79	– 98/79	EUDAMED record Report an error
Plasminogen activator-inhibitors	W0103020506	Tissue-Type Plasminogen Activator Inhibitor-1 Complex (t-PAIC) Rapid Quantitative Test2 refs98/79	– 98/79	EUDAMED record Report an error
Tb-igra (interferon-gamma-release assay)	W0105010704	TB Specific Cell Immune Response Detection Kit2 refs98/79	– 98/79	EUDAMED record Report an error
Thrombin-antithrombin III-complex	W0103020307	Thrombin-Antithrombin Ⅲ Complex (TAT) Rapid Quantitative Test2 refs98/79	– 98/79	EUDAMED record Report an error
Various rapid test chemistry / immunochemistry instruments - other	W0201069099	Fluorescent Immuno-analyzer98/79	– 98/79	EUDAMED record Report an error

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