Manufacturer

Shenzhen New Industries Biomedical Engineering

ChinaLegal entities : Shenzhen New Industries Biomedical Engineering Co., Ltd.

Markets : Germany · Italy · United States

Approvals : EU – class A, B, C · United States (FDA) – 510(k) : 5 · class I, II · latest in 2024 · see on the FDA website

EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)

Website

31 categories, 61 models including 61 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
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Category	EMDN code	Registered models	Class	Contact
Other virology controls - inf.imm.	W0105080804	MAGLUMI Anti-Dengue Virus IgG (CLIA) Controls MAGLUMI Anti-Dengue Virus IgM (CLIA) Controls MAGLUMI CMV IgG (CLIA) Controls MAGLUMI Dengue virus NS1 Antigen (CLIA) Controls MAGLUMI EBV EA IgA (CLIA) Controls 6 others MAGLUMI EBV EA IgG (CLIA) Controls MAGLUMI EBV NA IgA (CLIA) Controls MAGLUMI EBV VCA IgA (CLIA) Controls MAGLUMI HSV-1 IgM (CLIA) Controls MAGLUMI HSV-1/2 IgM (CLIA) Controls MAGLUMI HSV-2 IgM (CLIA) Controls	B, C IVDR	EUDAMED record Report an error
Bacteriology controls - inf.imm.	W0105080801	MAGLUMI Chlamydia pneumoniae IgG (CLIA) Controls MAGLUMI Chlamydia pneumoniae IgM (CLIA) Controls MAGLUMI H.pylori IgM (CLIA) Controls MAGLUMI Mycoplasma pneumoniae IgG (CLIA) Controls MAGLUMI Mycoplasma pneumoniae IgM (CLIA) Controls	B, C IVDR	EUDAMED record Report an error
Coagulometers - consumables	W0202020185	Hemolumi Bead Hemolumi Coagulation analyzer cleaning solution 1 Hemolumi Coagulation analyzer cleaning solution 2 Hemolumi Cuvette	A IVDR	EUDAMED record Report an error
Calibration plasma for haemostasis	W0103020701	Hemolumi Coagulation Calibrators4 refs98/79 Hemolumi D-Dimer Calibrators4 refs98/79 Hemolumi FDP Calibrators4 refs98/79	– 98/79	EUDAMED record Report an error
Haemostasis controls - other	W0103020799	Hemolumi Coagulation Controls10 refs98/79 Hemolumi D-Dimer Controls8 refs98/79 Hemolumi FDP Controls8 refs98/79	– 98/79	EUDAMED record Report an error
Hepatitis virus controls - inf.imm.	W0105080802	MAGLUMI Anti-HAV (CLIA) Controls MAGLUMI HEV IgG (CLIA) Controls MAGLUMI HEV IgM (CLIA) Controls	B, C IVDR	EUDAMED record Report an error
Influenza & para influenza	W0105040604	MAGLUMI Human Parainfluenza Virus IgM (CLIA)3 refs MAGLUMI Influenza A Virus IgM (CLIA)3 refs MAGLUMI Influenza B Virus IgM (CLIA)3 refs	B IVDR	EUDAMED record Report an error
Automated immunochemistry analysers - moderate routine (throughput > 100 and <= 250 test/h)	W0201020102	MAGLUMI 800 Fully-auto chemiluminescence immunoassay analyzer MAGLUMI X3 Fully-auto chemiluminescence immunoassay analyzer	A IVDR	EUDAMED record Report an error
Automated immunochemistry analysers - moderate to high routine (throughput > 250 and <= 700 test/h)	W0201020103	MAGLUMI X6 Fully-auto chemiluminescence immunoassay analyzer MAGLUMI X8 Fully-auto chemiluminescence immunoassay analyzer	A IVDR	EUDAMED record Report an error
Automated systems for the management of pre and post-analysis	W02060101	Bypass Module 1 SATLARS T83 refs Centrifuge Module I SATLARS mini-T83 refs	A IVDR	EUDAMED record Report an error
Robotic sample processing systems - consumables	W02060185	SATLAR Sample tube cap SATLARS Aluminum foil roll	A IVDR	EUDAMED record Report an error
Samples analyses, plastic cuvettes	W0503010203	MAGLUMI Reaction Cup MAGLUMI Reaction Module	A IVDR	EUDAMED record Report an error
Activated partial thromboplastin time	W0103020102	Hemolumi APTT (Clotting Assay)10 refs98/79	– 98/79	EUDAMED record Report an error
Adenovirus	W0105040601	MAGLUMI Adenovirus IgM (CLIA)3 refs	B IVDR	EUDAMED record Report an error
Antithrombin	W0103020602	Hemolumi AT III (Chromogenic Substrate Assay)10 refs98/79	– 98/79	EUDAMED record Report an error
Automated coagulometers	W0202020102	Hemolumi Automated coagulation analyzer	A IVDR	EUDAMED record Report an error
Automated immunochemistry analysers - consumables	W0201020185	MAGLUMI System Tubing Cleaning Solution	A IVDR	EUDAMED record Report an error
Automated immunochemistry analysers - high routine (throughput > 700 test/h)	W0201020104	MAGLUMI Fully-auto chemiluminescence immunoassay analyzer MAGLUMI X102 refs	A IVDR	EUDAMED record Report an error
Automated immunochemistry analysers - IVD medical device software	W0201020192	Preaccu	C IVDR	EUDAMED record Report an error
D-dimer	W0103020503	Hemolumi D-Dimer (Latex)8 refs98/79	– 98/79	EUDAMED record Report an error
Enterovirus	W0105040602	MAGLUMI Coxsackievirus B IgM (CLIA)3 refs	B IVDR	EUDAMED record Report an error
Fibrinogen assays (factor i)	W0103020201	Hemolumi Fibrinogen (Clotting Assay)10 refs98/79	– 98/79	EUDAMED record Report an error
Fibrinogen degradation products	W0103020502	Hemolumi FDP (Latex)8 refs98/79	– 98/79	EUDAMED record Report an error
Haemostasis reagents - other	W01030299	Hemolumi Sample Diluent6 refs	A IVDR	EUDAMED record Report an error
Legionella antibody assays	W0105010502	MAGLUMI Legionella pneumophila IgM (CLIA)3 refs	B IVDR	EUDAMED record Report an error
Parasitology controls - inf.imm.	W0105080805	MAGLUMI Toxo IgG (CLIA) Controls	C IVDR	EUDAMED record Report an error
Pipettes, tips without filter	W0503020202	MAGLUMI Tip	A IVDR	EUDAMED record Report an error
Prothrombin time ( quick test )	W0103020101	Hemolumi PT (Clotting Assay)10 refs98/79	– 98/79	EUDAMED record Report an error
Respiratory syncytial virus (rsv)	W0105040605	MAGLUMI Respiratory Syncytial Virus IgM (CLIA)3 refs	B IVDR	EUDAMED record Report an error
Samples transport, bags	W05020105	MAGLUMI Waste Bag2 refs	A IVDR	EUDAMED record Report an error
Thrombin time / reptilase / batroxobin time	W0103020103	Hemolumi TT (Clotting Assay)10 refs98/79	– 98/79	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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