Manufacturer

Keyubio

ChinaLegal entities : Zhuhai Keyu Biological Engineering Co., Ltd

Markets : Netherlands · Spain

Approvals : EU – class A

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

Website export@keyubio.com

15 categories, 45 models including 45 on the market, 1 country

Export to CSV

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
H. pylori antigen detection	W0105010401	KEYU H. Pylori Rapid Rapid Test (Colloidal Gold) HP-R-F98/79 KEYU H. Pylori Rapid Rapid Test (Colloidal Gold) HP-R-G98/79 KEYU H. Pylori Rapid Test Kit (Colloidal gold method) HP-I98/79 KEYU H. Pylori Rapid Test Kit (Colloidal gold method) HP-II98/79 KEYU H. Pylori Rapid Test Kit (Colloidal gold method) HP-III98/79 2 others KEYU H.pylori Antigen Test Kit (Fluorescence Immunochromatography) HP-F-Ⅰ98/79 KEYU H.pylori Antigen Test Kit (Fluorescence Immunochromatography) HP-F-Ⅱ98/79	– 98/79	EUDAMED record Report an error
Faeces collection devices	W05019001	KEYU ParaFloat™ Intestinal Parasite Concentrator (Ova) KU-F05-II KEYU ParaSpin™ Intestinal Parasite Concentrator KU-F05-I KEYU ParaSpin™ Intestinal Parasite Concentrator KU-F05-IV KEYU Sample Collection Container3 refs KEYU Sample Collection Cup3 refs 1 other KEYU Sample Collection Tube2 refs	A IVDR	EUDAMED record Report an error
Rotavirus	W0105040606	KEYU Rotavirus (RV) Group A Antigen Test Kit (Colloidal gold method) ARV-I98/79 KEYU Rotavirus (RV) Group A Antigen Test Kit (Colloidal gold method) ARV-II98/79 KEYU Rotavirus (RV) Group A Antigen Test Kit (Colloidal gold method) ARV-III98/79 KEYU Rotavirus Group A Antigen Rapid Test (Colloidal Gold) RV-R-F98/79 KEYU Rotavirus Group A Antigen Rapid Test (Colloidal Gold) RV-R-G98/79	– 98/79	EUDAMED record Report an error
Urinalysis (ur) - laboratory analysers - consumables	W02010785	KEYU Cleaning Solution C C-C01 KEYU Diluent Solution C2 refs KEYU Maintenance Solution3 refs KEYU Urine Analyzer Cleaning Solution2 refs KEYU Urine Analyzer Diluent Solution3 refs	A IVDR	EUDAMED record Report an error
Urinary sediment devices	W0201010202	KEYU Urine Sediment Analyzer KU-200098/79 KEYU Urine Sediment Analyzer KU-2000B98/79 KEYU Urine Sediment Analyzer KU-60098/79 KEYU Urine Sediment Analyzer KU-600A98/79 KEYU Urine Sediment Analyzer UM-3098/79	– 98/79	EUDAMED record Report an error
Laboratory instruments for microscopic investigations - consumables	W0202050385	KEYU Cleaning Solution KEYU Concentrated Cleaning Solution KEYU Concentrated Cleaning Solution II KU-W-01 KEYU Feces analyzer Cleaning Solution	A IVDR	EUDAMED record Report an error
Automated urine analysers	W020101020103	KEYU Automatic Urine Analysis System KU-280098/79 KEYU Automatic Urine Analysis System KU-300098/79	– 98/79	EUDAMED record Report an error
Chemistry instruments - other	W02010199	KEYU Feces Analyzer3 refs KEYU Feces Analyzer KU-F50S98/79	A IVDR, 98/79	EUDAMED record Report an error
Norovirus	W0105040616	KEYU Norovirus Antigen Test Kit (Colloidal gold method) NV-I98/79 KEYU Norovirus Antigen Test Kit (Colloidal gold method) NV-II98/79	– 98/79	EUDAMED record Report an error
Urine collection, tubes	W05010202	KEYU Sample Collection Tube2 refs KEYU Urine Sample Collection Tube2 refs	A IVDR	EUDAMED record Report an error
Cryptosporidium	W0105050207	KEYU Cryptosporidium Antigen Test Kit (Colloidal Gold Method) CRY-Ⅰ98/79	– 98/79	EUDAMED record Report an error
Entamoeba histolytica	W0105050201	KEYU Entamoeba histolytica Antigen Test Kit (Colloidal Gold Method)98/79	– 98/79	EUDAMED record Report an error
Immunochemistry instruments - other	W02010299	KEYU Fluorescence Immunoassay Analyzer	A IVDR	EUDAMED record Report an error
Immunochemistry readers	W0201020201	KEYU Fluorescent Immunoassay Analyzer FI-650S	A IVDR	EUDAMED record Report an error
Urine strip readers	W020101020101	KEYU Dry Chemistry Urine Analyzer3 refs	A IVDR	EUDAMED record Report an error

A model registered in EUDAMED is not necessarily sold in your country. Check availability and CE marking with the manufacturer.

Didn't find it?

Tell us what you are looking for. Requests show us which categories to add first.