Manufacturer

Genrui Biotech

ChinaLegal entities : Genrui Biotech Inc.

Markets : Belgium · Bulgaria · Cyprus · France · Germany · Greece · Italy · Romania · Spain · Türkiye · United States

Approvals : EU – class A, B · United States (FDA) – · class I

EU representative : Lotus NL B.V. (Netherlands)

Website service@genrui-bio.com

17 categories, 42 models including 42 on the market, 1 country

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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
Cbc-reagents (cleaning-/diluting-/lysing-/sheath-fluids)	W0103010105	E-Z Cleanser KT03 Diluent please see UDI-DI for details2 refs KT03 Lyse Solution Please see UDI-DIs for details.2 refs KT05 DIFF Lyse Please see UDI-DIs for details2 refs KT05/KT05A LD Lyse2 refs 3 others KT05A DIL Diluent KT05A LH Lyse Please see UDI-DIs for details3 refs Probe Cleanser4 refs	A IVDR	EUDAMED record Report an error
Automated whole blood hematology analysers - low routine (throughput <= 100 samples/hr)	W0202010101	KT-650098/79 KT-651098/79 KT-660098/79 KT-661098/79 KT-800098/79	– 98/79	EUDAMED record Report an error
Automated 3 part hematology analysers	W0202010201	Auto Hematology Analyzer KT-62, KT-60, KT-40, KT-422 refs Auto Hematology Analyzer KT-630098/79 KT-4098/79 KT-6098/79	B IVDR, 98/79	EUDAMED record Report an error
Automated immunochemistry analysers - low routine (throughput <= 100 test/h)	W0201020101	Auto Chemiluminescence Immunoassay Analyzer MT60, MT60S2 refs Fully-auto Specific Protein Analyzer PA120 Specific Protein Analyzer PA50, PA542 refs	A IVDR	EUDAMED record Report an error
D-dimer	W0103020503	D-Dimer Detection Kit (Nephelometry)98/79 D-Dimer Detection Kit (Nephelometry) 2*25 tests98/79 D-Dimer Detection Kit (Nephelometry) 25 tests98/79	– 98/79	EUDAMED record Report an error
Immunochemistry readers	W0201020201	FA20 Quantitative lmmunoassay Analyzer FA30, FA31 Quantitative lmmunoassay Analyzer FA50	A IVDR	EUDAMED record Report an error
Automated immunochemistry analysers - moderate routine (throughput > 100 and <= 250 test/h)	W0201020102	Auto Chemiluminescence Analyzer MT120S, MT120 Fully-auto Specific Protein Analyzer PA480，PA2402 refs	A IVDR	EUDAMED record Report an error
Chemistry analysers - low routine (random access without ise mode test/h <= 400)	W0201010101	Auto Chemistry Analyzer GS100 Auto Chemistry Analyzer GS300Plus, GS480A2 refs	A IVDR	EUDAMED record Report an error
D-dimer - RT & POC	W0103020803	50T/Kit98/79 D-Dimer test kit (Immunofluorescence) 25T/kit98/79	– 98/79	EUDAMED record Report an error
Fibrinogen degradation products	W0103020502	2*25 tests98/79 25 tests98/79	– 98/79	EUDAMED record Report an error
Interleukin 6 (il-6)	W01030609	Interleukin 6 (IL-6) Test Kit (Immunofluorescence) 25T/kit98/79 Interleukin 6 (IL-6) Test Kit (Immunofluorescence) 50T/Kit98/79	– 98/79	EUDAMED record Report an error
Cytokines calibrators/controls	W01030608	Interleukin 6 (IL-6) Quality Control98/79	– 98/79	EUDAMED record Report an error
Haemostasis controls - other	W0103020799	D-Dimer Quality Control98/79	– 98/79	EUDAMED record Report an error
Ion selective electrolyte analysers	W0201040201	GE30098/79	– 98/79	EUDAMED record Report an error
Limited panel chemistry analysers - other	W0201010299	WP21A, WP21B, WP21E3 refs	A IVDR	EUDAMED record Report an error
Semi-automated coagulometers	W0202020101	Coagulation Analyzer CA51, CA52, CA543 refs	A IVDR	EUDAMED record Report an error
Various sample processing instruments - other	W02069099	Immunofluorescence Incubator FI61	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.

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