Manufacturer

Maccura

ChinaLegal entities : Maccura Biotechnology Co., Ltd., Maccura Medical Instrument Co., Ltd.

Markets : Germany · Italy · Slovenia · Spain · Türkiye

Approvals : EU – class A, B

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

Website

56 categories, 177 models including 177 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
Reticulocyte controls	W0103010506	Hematology Analyzer Reticulocyte Control EBL220110098/79 Hematology Analyzer Reticulocyte Control EBL220210098/79 Hematology Analyzer Reticulocyte Control EBL220310098/79 Hematology Analyzer Reticulocyte Control EBL220410098/79 Hematology Analyzer Reticulocyte Control EBL220510098/79 21 others Hematology Analyzer Reticulocyte Control EBL220610098/79 Hematology Analyzer Reticulocyte Control EBL220710098/79 Hematology Analyzer Reticulocyte Control EBL220810098/79 Hematology Analyzer Reticulocyte Control EBL220910098/79 Hematology Analyzer Reticulocyte Control EBL221010098/79 Hematology Analyzer Reticulocyte Control EBL221110098/79 Hematology Analyzer Reticulocyte Control EBL221210098/79 Hematology Analyzer Reticulocyte Control EBL221310098/79 Hematology Analyzer Reticulocyte Control EBL221410098/79 Hematology Analyzer Reticulocyte Control EBL221510098/79 Hematology Analyzer Reticulocyte Control EBL221610098/79 Hematology Analyzer Reticulocyte Control EBL221710098/79 Hematology Analyzer Reticulocyte Control EBL221810098/79 Hematology Analyzer Reticulocyte Control EBL221910098/79 Hematology Analyzer Reticulocyte Control EBL222010098/79 Hematology Analyzer Reticulocyte Control EBL222110098/79 Hematology Analyzer Reticulocyte Control EBL222210098/79 Hematology Analyzer Reticulocyte Control EBL222310098/79 Hematology Analyzer Reticulocyte Control EBL222410098/79 Hematology Analyzer Reticulocyte Control EBL222610098/79 Hematology Analyzer Reticulocyte Control EBL222710098/79	– 98/79	EUDAMED record Report an error
Haematology controls - other	W0103010599	Hematology Analyzer Calibrator EBL220100298/79 Hematology Analyzer Control EBL220100398/79 Hematology Analyzer Control EBL220100498/79 Hematology Analyzer Control EBL220200298/79 Hematology Analyzer Control EBL220200398/79 20 others Hematology Analyzer Control EBL220200498/79 Hematology Analyzer Control EBL220300298/79 Hematology Analyzer Control EBL220300398/79 Hematology Analyzer Control EBL220300498/79 Hematology Analyzer Control EBL220400298/79 Hematology Analyzer Control EBL220400398/79 Hematology Analyzer Control EBL220400498/79 Hematology Analyzer Control EBL220900298/79 Hematology Control EBL229100198/79 Hematology Control EBL229100298/79 Hematology Control EBL229100398/79 Hematology Control EBL229200198/79 Hematology Control EBL229200298/79 Hematology Control EBL229200398/79 Hematology Control EBL229600198/79 Hematology Control EBL229600298/79 Hematology Control EBL229600398/79 Hematology Control EBL229700198/79 Hematology Control EBL229700298/79 Hematology Control EBL229700398/79	– 98/79	EUDAMED record Report an error
Whole blood calibrators	W0103010507	Hematology Analyzer Calibrator EBL220100198/79 Hematology Analyzer Calibrator EBL220200198/79 Hematology Analyzer Calibrator EBL220300198/79 Hematology Analyzer Calibrator EBL220400198/79 Hematology Analyzer Calibrator EBL220500198/79 11 others Hematology Analyzer Calibrator EBL220600198/79 Hematology Analyzer Fluorescent Platelets Calibrator6 refs98/79 Hematology Analyzer Reticulocyte Calibrator EBL228110098/79 Hematology Analyzer Reticulocyte Calibrator EBL228210098/79 Hematology Analyzer Reticulocyte Calibrator EBL228310098/79 Hematology Analyzer Reticulocyte Calibrator EBL228410098/79 Hematology Analyzer Reticulocyte Calibrator EBL228510098/79 Hematology Analyzer Reticulocyte Calibrator EBL228610098/79 Hematology Analyzer Reticulocyte Calibrator EBL228710098/79 Hematology Analyzer Reticulocyte Calibrator EBL228810098/79 Hematology Analyzer Reticulocyte Calibrator EBL228910098/79	– 98/79	EUDAMED record Report an error
Reagents for (automated) haematology analyzer - other	W0103010199	Automatic Hematology Analyzer DD-5 Fluorescent Dye A 42 mL×1; 42 mL×3 Automatic Hematology Analyzer F-DK Diluent 10 L×1; 20 L×1 Automatic Hematology Analyzer F-DR Diluent 1 L×1 ; 1 L×4 ; 2 L×1 ; 2 L×4 Automatic Hematology Analyzer F-FA Fluorescent Dye 10 mL×1 ;10 mL×2 ;20 mL×1;20 mL×2 Automatic Hematology Analyzer F-FD Fluorescent Dye 20 mL×1 ;20 mL×2 ;50 mL×1 ; 50 mL×2 8 others Automatic Hematology Analyzer F-FP Fluorescent Dye 10 mL×1 ; 10 mL×2 ;20 mL×1 ;20 mL×2 Automatic Hematology Analyzer F-FR Fluorescent Dye 10 mL×1 ;10 mL×2 ;20 mL×1 ;20 mL×2 Automatic Hematology Analyzer F-FW Fluorescent Dye 20 mL×1;20 mL×2;50 mL×1 ; 50 mL×2 Automatic Hematology Analyzer F-LA Lysing Reagent :1 L×1; 1 L×4 ;2 L×1 ;2 L×4 Automatic Hematology Analyzer F-LD Lysing Reagent 1 L×1 ; 1 L×4 ; 2 L×1 ; 2 L×4 ; 4 L×1 ; 4 L×4 Automatic Hematology Analyzer F-LS Lysing Reagent 1 L×1;1 L×4 ; 2 L×1; 2 L×4 ;4 L×1 ; 4 L×4 Automatic Hematology Analyzer F-LW Lysing Reagent 1 L×1 ;1 L×4 ;2 L×1 ;2 L×4 ; 4 L×1 ; 4 L×4 Automatic Hematology Analyzer FD-6 Fluorescent Dye 8 mL×1, 12 mL×1, 24 mL×1, 36 mL×1	A IVDR	EUDAMED record Report an error
Cbc-reagents (cleaning-/diluting-/lysing-/sheath-fluids)	W0103010105	Automatic Hematology Analyzer CC-5 Cell Clean A 2 mL×6 Automatic Hematology Analyzer F-DC Diluent BL2200243: 1 L×1 BL2201243: 20 L×12 refs Automatic Hematology Analyzer GD-5 Diluent A 20 L×1 Automatic Hematology Analyzer LD-5 Lysing Reagent A 1 L×4; 1 L×1 Automatic Hematology Analyzer LD-6 Lysing Reagent 500 mL×1 , 500 mL×2 ,1000 mL×1 ,1000 mL×23 refs 2 others Automatic Hematology Analyzer LH-5 Lysing Reagent A 500 mL×1; 500 mL×4 Automatic Hematology Analyzer LS-6 Lysing Reagent 500 mL×1, 500 mL×2, 1000 mL×1, 1000 mL×23 refs	A IVDR	EUDAMED record Report an error
D-dimer	W0103020503	D-Dimer EBL210100898/79 D-Dimer EBL210200898/79 D-Dimer EBL210300898/79 D-Dimer EBL210400898/79 D-Dimer EBL210500898/79 2 others D-Dimer EBL210600898/79 D-Dimer EBL210700898/79	– 98/79	EUDAMED record Report an error
Automated whole blood hematology analysers - low routine (throughput <= 100 samples/hr)	W0202010101	Automatic Hematology Analyzer F 56098/79 Automatic Hematology Analyzer F 560, F 580 Automatic Hematology Analyzer F 58098/79 Automatic Hematology Analyzer F 600 Automatic Hematology Analyzer F 680	B IVDR, 98/79	EUDAMED record Report an error
Controls - inf. immunology - other	W0105080899	anti-TP Control2 refs98/79 HSV-1/2 IgG Control6 refs98/79 HSV-1/2 IgM Control3 refs98/79 HSV-2 IgG Control6 refs98/79 IM4291315	B IVDR, 98/79	EUDAMED record Report an error
Automated whole blood hematology analysers - moderate routine (throughput > 100 and <= 120 samples/hr)	W0202010102	Automatic Hematology Analyzer F 80098/79 Automatic Hematology Analyzer F 81098/79 Automatic Hematology Analyzer F 88098/79 Automatic Hematology Analyzer F 880; F 810; F 8003 refs	B IVDR, 98/79	EUDAMED record Report an error
Calibration plasma for haemostasis	W0103020701	D-Dimer Calibrator EBL218100598/79 D-Dimer Calibrator EBL218200598/79 D-Dimer Calibrator EBL218300598/79 Fibrinogen Degradation Product (FDP) Calibrator98/79	– 98/79	EUDAMED record Report an error
Standards and calibrators - inf. immunology - other	W0105080999	HSV-1/2 IgG Calibrators3 refs98/79 HSV-1/2 IgM Calibrators3 refs98/79 HSV-2 IgG Calibrators3 refs98/79 Treponema Pallidum Antibody (anti-TP) Calibrators (Chemiluminescent Immunoassay)2 refs98/79	– 98/79	EUDAMED record Report an error
Urinalysis (ur) - laboratory analysers - consumables	W02010785	Urinalysis Hydrometer Cleaning Solution 100mL×1; 100mL×2 Urinalysis Sediment Detergent A 15 L×1 Urinalysis Sediment Detergent B 100 mL×1, 100 mL×2 Urinalysis Sediment Diluent 100mL×1	A IVDR	EUDAMED record Report an error
Automated immunochemistry analysers - moderate routine (throughput > 100 and <= 250 test/h)	W0201020102	Automatic Chemiluminescence Analyzer i 1000； i 1000L； i 1000S Automatic Chemiluminescence Analyzer i 800； i 820； i 6000； i 8000； i 9000 Hematology Analysis Automation Workstation LABAS F 9000 X	A IVDR	EUDAMED record Report an error
Samples analyses, plastic cuvettes	W0503010203	Chemiluminescence Analyzer Reaction Cuvettes 3500 Tests, 24 kits/Box Cuvettes 1000/Tray, 6Trays/Box S-Coagulation Reaction Cuvettes 4 Tests×200； 4 Tests×50	A IVDR	EUDAMED record Report an error
Automated coagulometers	W0202020102	Automatic Coagulation Analyzer H 3600/H 3800 Automatic Coagulation Analyzer H 5000/H 52002 refs	A IVDR	EUDAMED record Report an error
Automated whole blood hematology analysers - consumables	W0202010185	Automatic Hematology Analyzer F-CC Cell Clean 4 mL×1; 4 mL×2; 4 mL×6 Automatic Hematology Analyzer F-SC Cleaning Fluid 10 mL×1; 10 mL×2; 20 mL×1; 20 mL×2	A IVDR	EUDAMED record Report an error
Buffers (haemostasis)	W0103020903	Coagulation Analyzer Wash Buffer A (Coa-Wash A) 200.0 mL×2 Coagulation Analyzer Wash Buffer B (Coa-Wash B) 20.0 mL×12	A IVDR	EUDAMED record Report an error
Glycosilated hemoglobin devices	W0201060101	Glycated Hemoglobin Analyzer Column S EC940300198/79 Glycated Hemoglobin Analyzer Column S EC940400198/79	– 98/79	EUDAMED record Report an error
Hev antibody igg	W0105020504	HEV IgG Antibody Chemiluminescent Immunoassay Kit6 refs98/79 IM4402017 IM4403017 IM4406017 IM4407017 EIM44920173 refs	B IVDR, 98/79	EUDAMED record Report an error
Hsv 1+2 igg	W0105040303	HSV-1/2 IgG2 refs98/79 HSV-1/2 IgM98/79	– 98/79	EUDAMED record Report an error
Hsv 1+2 igm	W0105040304	HSV-1/2 IgM3 refs98/79 HSV-1/2 IgM Antibody Chemiluminescent Immunoassay Kit4 refs98/79	– 98/79	EUDAMED record Report an error
Mycoplasma antibody assays	W0105010802	IM4410040 IM4411040 IM4414040 IM44150403 refs IM4410041 IM4411041 IM4414041 IM44150413 refs	B IVDR	EUDAMED record Report an error
Nucleic acid testing integrated extraction /amplification /detection systems	W02050116	Automatic Nucleic Acid Extraction System N 32，N 962 refs Real-Time PCR System N 904	A IVDR	EUDAMED record Report an error
Activated partial thromboplastin time	W0103020102	APTT4 refs98/79	– 98/79	EUDAMED record Report an error
Automated immunochemistry analysers - low routine (throughput <= 100 test/h)	W0201020101	Automatic Specific Proteins Analyzer P 100; P 100S	A IVDR	EUDAMED record Report an error
Automated immunochemistry analysers - moderate to high routine (throughput > 250 and <= 700 test/h)	W0201020103	Automatic Chemiluminescence Analyzer i 6000	A IVDR	EUDAMED record Report an error
Automated sample transport systems	W02060102	Hematology Analysis Automation Workflow System LABAS F 2000	A IVDR	EUDAMED record Report an error
Automated slide stainers	W0202059002	Automatic Slide Maker and Stainer AS 120	A IVDR	EUDAMED record Report an error
Automated urine analysers	W020101020103	Automatic Urinalysis System U 2000, U 2000S	B IVDR	EUDAMED record Report an error
Chemistry analysers - moderate to high routine (random access without ise mode test/h > 800 and <= 1.200)	W0201010103	Automatic Chemistry Analyzer C 400, C410, C 600, C 610, C 1000, C 1100	A IVDR	EUDAMED record Report an error
Chlamydia pneumoniae antibody igg	W0105010115	EIM4410015 EIM4411015 EIM4414015 EIM44150153 refs	B IVDR	EUDAMED record Report an error
Chlamydia pneumoniae antibody igm	W0105010116	EIM4410016 EIM4411016 EIM4414016 EIM44150163 refs	B IVDR	EUDAMED record Report an error
Control plasma for haemostasis	W0103020702	Coagulation Quality Control Plasma (CQC)8 refs98/79	– 98/79	EUDAMED record Report an error
Fibrinogen assays (factor i)	W0103020201	Fibrinogen (Fib)4 refs98/79	– 98/79	EUDAMED record Report an error
Fibrinogen degradation products	W0103020502	Fibrinogen Degradation Product (FDP)7 refs98/79	– 98/79	EUDAMED record Report an error
General coagulation tests - other	W0103020199	Coagulation Analyzer Sample Diluent（CASD） 10.0 mL×12, 20.0 mL×12	A IVDR	EUDAMED record Report an error
Haemostasis controls - other	W0103020799	D-Dimer & FDP Control4 refs98/79	– 98/79	EUDAMED record Report an error
Hav antibody igm	W0105020104	IM4405010 IM4401010 IM4406010 IM44070103 refs	B IVDR	EUDAMED record Report an error
Hev antibody igm	W0105020505	HEV IgM Antibody Chemiluminescent Immunoassay Kit6 refs98/79	– 98/79	EUDAMED record Report an error
Hsv 2 igg	W0105040309	HSV-2 IgG3 refs98/79	– 98/79	EUDAMED record Report an error
Interleukin 6 (il-6)	W01030609	IL-6 Chemiluminescent Immunoassay Kit4 refs98/79	– 98/79	EUDAMED record Report an error
IVD instruments - other	W0299	Chemistry and Immunoassay Integrated System SAC-12, IOM-01, IOM-02, RWC-01, DQI-01, ST-04, ST-05, i 6000, C 1000, ISE	A IVDR	EUDAMED record Report an error
Platelet controls	W0103010505	Hematology Analyzer Fluorescent Platelets Control13 refs98/79	– 98/79	EUDAMED record Report an error
Prothrombin time ( quick test )	W0103020101	Prothrombin Time (PT)5 refs98/79	– 98/79	EUDAMED record Report an error
Reagents for DNA and/or RNA extraction and preparation: bacteria and/or virus	W0105900101	Mag-Bind RNA Extraction Kit 16 Tests, 32 Tests, 48 Tests, 96 Tests (A), 480 Tests (A) ,96 Tests（C）, 480 Tests（C）, 32 Tests（C）	A IVDR	EUDAMED record Report an error
Respiratory syncytial virus (rsv)	W0105040605	SARS-CoV-2 Antigen (CLIA)98/79	– 98/79	EUDAMED record Report an error
Samples analyses, containers - other	W05030199	Automatic Specific Proteins Analyzer Cuvettes 4 Tests	A IVDR	EUDAMED record Report an error
Samples analyses, glass cuvettes	W0503010102	Cuvettes 17Strip/Box ,1 Strip/Box	A IVDR	EUDAMED record Report an error
Semi-automated coagulometers	W0202020101	Semi-Automatic Coagulation Analyzer H-04	A IVDR	EUDAMED record Report an error
Semi-automated urine analysers	W020101020102	Semi-Automatic Urine Analyzer U 350; U 370; U 3902 refs	A IVDR	EUDAMED record Report an error
Setup beads	W0103080401	Demagnetization Beads 1700 Tests; 220 Tests	A IVDR	EUDAMED record Report an error
Syphilis antibody assays total	W0105010302	Treponema Pallidum Antibody (anti-TP) Assay Kit (Chemiluminescent Immunoassay)3 refs98/79	– 98/79	EUDAMED record Report an error
Thrombin time / reptilase / batroxobin time	W0103020103	Thrombin Time (TT)4 refs98/79	– 98/79	EUDAMED record Report an error
Toxoplasma antibody igg	W0105050102	TOXO IgG Antibody Chemiluminescent Immunoassay Kit2 refs98/79	– 98/79	EUDAMED record Report an error
Toxoplasma antibody igm	W0105050103	TOXO IgM Antibody Chemiluminescent Immunoassay Kit2 refs98/79	– 98/79	EUDAMED record Report an error
Various sample processing instruments - other	W02069099	Total Laboratory Automation IOM-03, IOM-06, IOM-07, ICM-01	A IVDR	EUDAMED record Report an error

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