Manufacturer

Biobase

ChinaLegal entities : BIOBASE POCT CO.,LTD, Biobase Biodustry(Shandong) Co.,Ltd., Biobase Scientific (Shandong) Co.,Ltd

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

EU representative : Luxus Lebenswelt GmbH (Germany)

40 categories, 142 models including 142 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
Fibrinogen assays (factor i)	W0103020201	Fibrinogen (Fb)Test Kit (Immunoturbidimetric) Calibrator：1mL×1(91036)98/79 Fibrinogen (Fb)Test Kit (Immunoturbidimetric) Quality Control：1mL×1(92031)98/79 Fibrinogen (Fb)Test Kit (Immunoturbidimetric) R1:18mL×1 R2:6mL×1(702)98/79 Fibrinogen (Fb)Test Kit (Immunoturbidimetric) R1:18mL×4 R2:6mL×4(707)98/79 Fibrinogen (Fb)Test Kit (Immunoturbidimetric) R1:18mL×4 R2:6mL×4(709)98/79 26 others Fibrinogen (Fb)Test Kit (Immunoturbidimetric) R1:18mL×4 R2:6mL×4（710）98/79 Fibrinogen (Fb)Test Kit (Immunoturbidimetric) R1:18mL×4 R2:6mL×4（796）98/79 Fibrinogen (Fb)Test Kit (Immunoturbidimetric) R1:40ml×3 R2:20ml×2（704）98/79 Fibrinogen (Fb)Test Kit (Immunoturbidimetric) R1:48ml×2 R2:16ml×2（705）98/79 Fibrinogen (Fb)Test Kit (Immunoturbidimetric) R1:48ml×2 R2:16ml×2（713）98/79 Fibrinogen (Fb)Test Kit (Immunoturbidimetric) R1:48ml×2 R2:16ml×2（715）98/79 Fibrinogen (Fb)Test Kit (Immunoturbidimetric) R1:48ml×2 R2:16ml×2（716）98/79 Fibrinogen (Fb)Test Kit (Immunoturbidimetric) R1:48ml×2 R2:16ml×2（791）98/79 Fibrinogen (Fb)Test Kit (Immunoturbidimetric) R1:48ml×2 R2:16ml×2（793）98/79 Fibrinogen (Fb)Test Kit (Immunoturbidimetric) R1:48ml×2 R2:16ml×2（798）98/79 Fibrinogen (Fb)Test Kit (Immunoturbidimetric) R1:48ml×2 R2:32ml×1（792）98/79 Fibrinogen (Fb)Test Kit (Immunoturbidimetric) R1:60ml ×1 R2:20ml×1（703）98/79 Fibrinogen (Fb)Test Kit (Immunoturbidimetric) R1:60mL×2 R2:20mL×2(701)98/79 Fibrinogen (Fb)Test Kit (Immunoturbidimetric) R1:60mL×2 R2:20mL×2（706）98/79 Fibrinogen (Fb)Test Kit (Immunoturbidimetric) R1:60mL×2 R2:20mL×2（794）98/79 Fibrinogen (Fb)Test Kit (Immunoturbidimetric) R1:60ml×6 R2:60ml×2（795）98/79 Fibrinogen (Fb)Test Kit (Immunoturbidimetric) R1:90ml×1 R2:30ml×1（708）98/79 Fibrinogen (FIB) Test Kit (Coagulation) Calibration plasma: 0.5mL×1（511001）98/79 Fibrinogen (FIB) Test Kit (Coagulation) Calibration plasma: 1.0mL×1（511002）98/79 Fibrinogen (FIB) Test Kit (Coagulation) Freeze-dried： Reagent:2.5mL×5, Diluent:50mL×2（502001）98/79 Fibrinogen (FIB) Test Kit (Coagulation) Freeze-dried：Reagent:1mL×10,Diluent:50mL×2（503001）98/79 Fibrinogen (FIB) Test Kit (Coagulation) Freeze-dried：Reagent:2mL×5, Diluent:50mL×2（501001）98/79 Fibrinogen (FIB) Test Kit (Coagulation) Quality control plasma (abnormal): 0.5mL×1（521002）98/79 Fibrinogen (FIB) Test Kit (Coagulation) Quality control plasma (abnormal): 1.0mL×1（521004）98/79 Fibrinogen (FIB) Test Kit (Coagulation) Quality control plasma (normal): 0.5mL×1（521001）98/79 Fibrinogen (FIB) Test Kit (Coagulation) Quality control plasma (normal): 1.0mL×1（521003）98/79	– 98/79	EUDAMED record Report an error
D-dimer	W0103020503	D-Dimer (DD) Test Kit (Immunoturbidimetric) Calibrator：1mL×1(91134)98/79 D-Dimer (DD) Test Kit (Immunoturbidimetric) Quality Control：1mL×2(92146)98/79 D-Dimer (DD) Test Kit (Immunoturbidimetric) R1:18mL×1 R2:6mL×1(702)98/79 D-Dimer (DD) Test Kit (Immunoturbidimetric) R1:18mL×4 R2:6mL×4(709)98/79 D-Dimer (DD) Test Kit (Immunoturbidimetric) R1:18mL×4 R2:6mL×4（707）98/79 17 others D-Dimer (DD) Test Kit (Immunoturbidimetric) R1:18mL×4 R2:6mL×4（710）98/79 D-Dimer (DD) Test Kit (Immunoturbidimetric) R1:18mL×4 R2:6mL×4（796）98/79 D-Dimer (DD) Test Kit (Immunoturbidimetric) R1:40mL×3 R2:20mL×2（704）98/79 D-Dimer (DD) Test Kit (Immunoturbidimetric) R1:48mL×2 R2:32mL×1（792）98/79 D-Dimer (DD) Test Kit (Immunoturbidimetric) R1:48mL×2 R2:32mL×1（793）98/79 D-Dimer (DD) Test Kit (Immunoturbidimetric) R1:48mL×2 R2:16mL×2(705)98/79 D-Dimer (DD) Test Kit (Immunoturbidimetric) R1:48mL×2 R2:16mL×2(713)98/79 D-Dimer (DD) Test Kit (Immunoturbidimetric) R1:48mL×2 R2:16mL×2（715）98/79 D-Dimer (DD) Test Kit (Immunoturbidimetric) R1:48mL×2 R2:16mL×2（716）98/79 D-Dimer (DD) Test Kit (Immunoturbidimetric) R1:48mL×2 R2:16mL×2（791）98/79 D-Dimer (DD) Test Kit (Immunoturbidimetric) R1:48mL×2 R2:16mL×2（798）98/79 D-Dimer (DD) Test Kit (Immunoturbidimetric) R1:60mL×1 R2:20mL×1（703）98/79 D-Dimer (DD) Test Kit (Immunoturbidimetric) R1:60mL×2 R2:20mL×2(701)98/79 D-Dimer (DD) Test Kit (Immunoturbidimetric) R1:60mL×2 R2:20mL×2（706）98/79 D-Dimer (DD) Test Kit (Immunoturbidimetric) R1:60mL×2 R2:20mL×2（794）98/79 D-Dimer (DD) Test Kit (Immunoturbidimetric) R1:60mL×6 R2:60mL×2（795）98/79 D-Dimer (DD) Test Kit (Immunoturbidimetric) R1:90mL×1 R2:30mL×1(708)98/79	– 98/79	EUDAMED record Report an error
Cbc-reagents (cleaning-/diluting-/lysing-/sheath-fluids)	W0103010105	Hematology Analyzer Diluent3 refs Hematology Analyzer Diluent 10×SFL-1 2L（10106）98/79 Hematology Analyzer Diluent 10×WFL-2 2L（15004）98/79 Hematology Analyzer Diluent SFL-1 10L（10201）98/79 Hematology Analyzer Lyse3 refs 3 others Hematology Analyzer Lyse WFL-DIFF 250mL（15006）98/79 Hematology Analyzer Lyse WFL-LH 200mL（15202）98/79 Hematology Analyzer Lyse WFL-LH 250mL（15002）98/79	A IVDR, 98/79	EUDAMED record Report an error
Activated partial thromboplastin time	W0103020102	Activated Partial Thromboplastin Time (APTT) Test kit (Coagulation) Reagent:2mL×10,CaCl2:25mL×1（501004）98/79 Actived Partial Thromboplastin Time(APTT)Assay kit(Coagulation) Quality control plasma(abnormal):0.5mL×1（521014）98/79 Actived Partial Thromboplastin Time(APTT)Assay kit(Coagulation) Quality control plasma(abnormal):1.0mL×1（521016）98/79 Actived Partial Thromboplastin Time(APTT)Assay kit(Coagulation) Quality control plasma(normal):0.5mL×1（521013）98/79 Actived Partial Thromboplastin Time(APTT)Assay kit(Coagulation) Quality control plasma(normal):1.0mL×1（521015）98/79 2 others Actived Partial Thromboplastin Time(APTT)Assay kit(Coagulation) Reagent:2.5mL×10,CaCl2:30mL×1（502004）98/79 Actived Partial Thromboplastin Time(APTT)Assay kit(Coagulation) Reagent:4mL×10,CaCl2:45mL×1（503004）98/79	– 98/79	EUDAMED record Report an error
Prothrombin time ( quick test )	W0103020101	Prothrombin Time (PT) Test Kit (Coagulation) Freeze-dried：Reagent:2.5mL×10,Reconstitution solution:30mL×1（502003）98/79 Prothrombin Time (PT) Test Kit (Coagulation) Freeze-dried：Reagent:2mL×10,Reconstitution solution:25mL×1（502003）98/79 Prothrombin Time (PT) Test Kit (Coagulation) Freeze-dried：Reagent:4mL×10,Reconstitution solution:45mL×1（503003）98/79 Prothrombin Time (PT) Test Kit (Coagulation) Quality control plasma (abnormal): 0.5mL×1（521010）98/79 Prothrombin Time (PT) Test Kit (Coagulation) Quality control plasma (abnormal): 1.0mL×1（521012）98/79 2 others Prothrombin Time (PT) Test Kit (Coagulation) Quality control plasma (normal): 0.5mL×1（521009）98/79 Prothrombin Time (PT) Test Kit (Coagulation) Quality control plasma (normal): 1.0mL×1（521011）98/79	– 98/79	EUDAMED record Report an error
Thrombin time / reptilase / batroxobin time	W0103020103	Thrombin Time (TT) Test Kit (Coagulation) Freeze-dried：Reagent 2.5mL×10, Reconstitution solution 30mL×1（502002）98/79 Thrombin Time (TT) Test Kit (Coagulation) Freeze-dried：Reagent 2mL×10, Reconstitution solution 25mL×1（501002）98/79 Thrombin Time (TT) Test Kit (Coagulation) Freeze-dried：Reagent 4mL×10, Reconstitution solution 45mL×1（503002）98/79 Thrombin Time (TT) Test Kit (Coagulation) Quality control plasma (abnormal): 0.5mL×1（521006）98/79 Thrombin Time (TT) Test Kit (Coagulation) Quality control plasma (abnormal): 1.0mL×1（521008）98/79 2 others Thrombin Time (TT) Test Kit (Coagulation) Quality control plasma (normal): 0.5mL×1（521005）98/79 Thrombin Time (TT) Test Kit (Coagulation) Quality control plasma (normal): 1.0mL×1（521007）98/79	– 98/79	EUDAMED record Report an error
IVD general use consumable devices - other	W0599	Acid Cleaning Solution 2L（93004） Alkaline Cleaning Solution 2L（93002） Alkaline Cleaning Solution C 60ml×2（93005）3 refs E-Z Cleaning Solution 100mL（10105） Probe Cleaning Solution Ⅱ 50mL（10109）2 refs	A IVDR	EUDAMED record Report an error
Virology - RT & POC - other	W0105099099	Chikungunya IgG/IgM Combo Rapid Test Kit (Colloidal Gold) 20 tests / kit98/79 Chikungunya IgG/IgM Combo Rapid Test Kit (Colloidal Gold) 25 tests / kit98/79 Parainfluenza Virus IgM Rapid Test Kit (Colloidal Gold) 25 tests / kit98/79 Zika Virus IgG/IgM Rapid Test Kit (Colloidal Gold) 20 tests / kit98/79 Zika Virus IgG/IgM Rapid Test Kit (Colloidal Gold) 25 tests / kit98/79	– 98/79	EUDAMED record Report an error
H. pylori - RT & POC	W0105090102	Helicobacter Pylori Antibody Rapid Test Kit (Colloidal Gold) 20 tests / kit98/79 Helicobacter Pylori Antibody Rapid Test Kit (Colloidal Gold) 25 tests / kit98/79 Helicobacter pylori antigen Rapid Test Kit (Colloidal Gold) 20 tests / kit98/79 Helicobacter pylori antigen Rapid Test Kit (Colloidal Gold) 25 tests / kit98/79	– 98/79	EUDAMED record Report an error
Bacteriology - RT & POC - other	W0105090199	Mycoplasma Pneumoniae IgM Rapid Test Kit (Colloidal Gold) 25 tests / kit98/79 Typhoid Rapid Test Kit（Colloidal Gold） 20 tests / kit98/79 Typhoid Rapid Test Kit（Colloidal Gold） 25 tests / kit98/79	– 98/79	EUDAMED record Report an error
Automated immunochemistry analysers - low routine (throughput <= 100 test/h)	W0201020101	Fluorescence Immunoassay Analyzer BKP1000，BKP2000, BKP30003 refs Portable Fluorescence Immunoassay Analyzer BKP500, BKP600, etc.	A IVDR	EUDAMED record Report an error
Biological hoods	W02070301	Biological Safety Cabinet 11231BBC86-Pro3 refs Biological Safety Cabinet 11234 BBC 863 refs	I MDR	EUDAMED record Report an error
Centrifuges	W02069003	Centrifuge BKC-AU5BT3 refs Medical Centrifuge BKC-DL6C3 refs	I MDR	EUDAMED record Report an error
Chemistry analysers - low routine (random access without ise mode test/h <= 400)	W0201010101	Automatic Chemistry Analyzer Spin XS， Spin XL ， Spin XT2 refs Semi-auto Chemistry Analyzer Biobase-Silver2 refs	A IVDR	EUDAMED record Report an error
Coronavirus antigen (ag) - RT & POC	W0105090501	Biobase COVID-19 Antigen Rapid Test Kit (Colloidal Gold) 20 tests / kit98/79 Biobase COVID-19 Antigen Rapid Test Kit (Colloidal Gold) 25 tests / kit98/79	– 98/79	EUDAMED record Report an error
Cryogenics / frozen	W020702	Freezer BDF-86V608T Laboratory Refrigerator BPR-5V1008F3 refs	I MDR	EUDAMED record Report an error
Dengue - RT & POC	W0105099007	Dengue Rapid Test Kit（Colloidal Gold） 20 tests / kit98/79 Dengue Rapid Test Kit（Colloidal Gold） 25 tests / kit98/79	– 98/79	EUDAMED record Report an error
Immunochemistry readers	W0201020201	Elisa Microplate Reader3 refs Elisa Plate Reader DIA2000	A IVDR	EUDAMED record Report an error
Influenza a and /or b - RT & POC	W0105099004	Combined Detection Kit For Influenza A/B (Colloidal Gold) 20 tests / kit98/79 Combined Detection Kit For Influenza A/B (Colloidal Gold) 25 tests / kit98/79	– 98/79	EUDAMED record Report an error
Plasmodium (malaria) - RT & POC	W0105090401	Malaria P.Falciparum/P.Vivax Rapid Test Kit（Colloidal Gold） 20 tests / kit98/79 Malaria P.Falciparum/P.Vivax Rapid Test Kit（Colloidal Gold） 25 tests / kit98/79	– 98/79	EUDAMED record Report an error
Reagents for DNA and/or RNA extraction and preparation: bacteria and/or virus	W0105900101	Nucleic Acid Extraction Kit II (Magnetic Beads Method) KY002 Nucleic Acid Extraction Kit (Magnetic Beads Method) 16 tests / box（121001）3 refs	A IVDR	EUDAMED record Report an error
Rsv - RT & POC	W0105099002	Respiratory syncytial virus Antigen Rapid Test Kit (Colloidal Gold) 20 tests / kit98/79 Respiratory syncytial virus Antigen Rapid Test Kit (Colloidal Gold) 25 tests / kit98/79	– 98/79	EUDAMED record Report an error
Samples collection devices - other	W05019099	Disposable Virus Sampling Collector2 refs Single-use Virus Sampling Tubes3 refs	A IVDR	EUDAMED record Report an error
Automated 3 part hematology analysers	W0202010201	Auto Hematology Analyzer BS010	A IVDR	EUDAMED record Report an error
Automated blood culture analysers	W02030201	Automated Blood Culture System BK-BC series3 refs	A IVDR	EUDAMED record Report an error
Automated sample transport systems	W02060102	Automated Liquid Handler BK-ASP48，BK-ASP48P，BK-ASP96, etc.3 refs	A IVDR	EUDAMED record Report an error
Automated whole blood hematology analysers - low routine (throughput <= 100 samples/hr)	W0202010101	5-Part Auto Hematology Analyzer	A IVDR	EUDAMED record Report an error
Autosamplers	W02069001	Automated Sample Processing System BS0032 refs	A IVDR	EUDAMED record Report an error
Blood banks refrigerators	Z121701	Medical Refrigerator BBR-4V1363 refs	I MDR	EUDAMED record Report an error
Chemistry analysers - moderate routine (random access without ise mode test/h > 400 and <= 800)	W0201010102	Automatic Chemistry Analyzer BK-20003 refs	A IVDR	EUDAMED record Report an error
Erythrocyte sedimentation rate devices	W02029001	Auto ESR Analyzer BK-ESR203 refs	A IVDR	EUDAMED record Report an error
Fume hoods	W02070302	Fume Hood XBX005	I MDR	EUDAMED record Report an error
Immunochemistry instruments - other	W02010299	Specific Protein Analyzer BK-PA120	A IVDR	EUDAMED record Report an error
Integrated / modular chemistry / immunochemistry instruments - other	W02010399	Automatic ELISA Processor	A IVDR	EUDAMED record Report an error
Ion selective electrolyte analysers	W0201040201	Electrolyte Analyzer BS006	A IVDR	EUDAMED record Report an error
IVD instruments - other	W0299	Microplate Washer3 refs	I MDR	EUDAMED record Report an error
Laminar airflow hoods	W02070303	Laminar Flow Cabinet XBX004	I MDR	EUDAMED record Report an error
Nucleic acid testing integrated extraction /amplification /detection systems	W02050116	Automatic Nucleic Acid Extraction System BK-HS32mini3 refs	A IVDR	EUDAMED record Report an error
Semi-automated coagulometers	W0202020101	Blood Coagulation Analyzer BS011	A IVDR	EUDAMED record Report an error
Semi-automated urine analysers	W020101020102	Urine Analyzer BS017	A IVDR	EUDAMED record Report an error

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