Manufacturer

Ukinbio

ChinaLegal entities : Shenzhen Ukin Biotech Co.,Ltd.

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

EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain)

9 categories, 16 models including 16 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
Automated whole blood hematology analysers - low routine (throughput <= 100 samples/hr)	W0202010101	Hematology Analyzer Huma 300098/79 Hematology Analyzer Huma 3000s98/79 Hematology Analyzer Huma 500098/79 Hematology Analyzer Huma 5000s98/79 Hematology Analyzer Huma mini98/79	– 98/79	EUDAMED record Report an error
Devices for samples analyses - other accessories	W05039080	Chromatographic Column (HPLC) C298/79 Chromatographic Column (HPLC) C498/79	– 98/79	EUDAMED record Report an error
High performance liquid chromatography systems	W0201050201	Glycohemoglobin Analyzer UKGH-20098/79 Glycohemoglobin Analyzer UKGH-31098/79	– 98/79	EUDAMED record Report an error
Immunochemistry readers	W0201020201	Fluorescence Immunochromatographic Analyzer iTest F100 / iTest F101 / iTest F800 / iTest F20003 refs Microplate ELISA Reader UKMR 480 / UKMR 960 / UKMR 20003 refs	A IVDR	EUDAMED record Report an error
Cbc-reagents (cleaning-/diluting-/lysing-/sheath-fluids)	W0103010105	Hematology Testing Pack HT 300 / HT5002 refs	A IVDR	EUDAMED record Report an error
Chemistry analysers - low routine (random access without ise mode test/h <= 400)	W0201010101	Automatic Biochemical Analyzer UKCA 2000 / UKCA 3000 / UKCA 6500 / UKCA 88003 refs	A IVDR	EUDAMED record Report an error
Mixed panel multiparameter analysers - low routine (throughput <= 800 test/h)	W0201030101	Real-Time PCR Fluorescent Quantitative Analyzer UKRT Qube / UKRT Mini / UKRT 320 / UKRT 9603 refs	A IVDR	EUDAMED record Report an error
Mycobacterial detection by NA reagents	W0105010703	Mycobacterium Tuberculosis and Drug-resistant Gene Nucleic Acid Testing Kit (PCR- Fluorescence Probing ) TB001FD98/79	– 98/79	EUDAMED record Report an error
Partial genotyping high-risk HPV - NA reagents	W0105041003	Nucleic Acid Detection Kit for High-risk Human Papillomavirus (Typing) (PCR-Fluorescence Probing) HPV002FD98/79	– 98/79	EUDAMED record Report an error

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