Haematology / haemostasis / immunohaematology / histology / cytologyHaematology reagentsReagents for (automated) haematology analyzer

Reagents for (automated) haematology analyzer - other

EMDN code W0103010199

26 manufacturers, 85 models including 85 on the market, 10 countries

On the market in Manufacturer country

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Manufacturers registered in Europe (EUDAMED) 26

On the market
No longer marketed
93/42 Former directive, not yet certified under the MDR
Click a manufacturer to see its full range, a model to open its EUDAMED record.

Manufacturer	Country	Registered models	Class	Contact
Leicabiosystems FDA EU representative : AR Experts B.V. (Netherlands) and 1 other	United Kingdom (ex Northern Ireland)	Anti-Biotin Antibody AR0584 Anti-Fluorescein Antibody AR02222 refs BOND DAB Enhancer AR9432 BOND Dewax Solution AR9222 BOND Enzyme Pretreatment Kit AR9551 11 others BOND Epitope Retrieval Solution 1 AR9961 BOND Epitope Retrieval Solution 2 AR9640 BOND Hybridization Solution AR9037 BOND Primary Antibody Diluent AR9352 BOND Wash Solution 10X Concentrate AR9590 BOND-PRIME Dewax Solution AR0084 BOND-PRIME Epitope Retrieval Solution 1 AR0086 BOND-PRIME Epitope Retrieval Solution 2 AR0087 BOND-PRIME Hematoxylin AR0096 BOND-PRIME Wash Solution Concentrate AR0085 Stringency Wash Solution AR0633	A IVDR	Website EUDAMED record Report an error
Maccura EU representative : CMC Medical Devices & Drugs SL (Spain) and 1 other	China	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	Website EUDAMED record Report an error
Medconn FDA EU representative : Lotus NL B.V. (Netherlands)	China	Glycated Hemoglobin (HbA1c) Column HC208C0198/79 HC207T0598/79 HC225C0198/79 HC230T0198/79 HC234T1098/79 7 others HC234T1698/79 HC235T0198/79 HC235T0498/79 HC236T0198/79 HC237T0298/79 HC237T0398/79 HC238C0898/79	– 98/79	EUDAMED record Report an error
Dezhou Guoke Medical Technology EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain)	China	Cleaner used for Hematology Analysis 50ml、200ml Diluent used for Hematology Analysis 5L、20L（SXHA610/650/660/680 Diluent） Diluent used for Hematology Analysis(HAS330) 5L、20L（LHAS310/330/360/380 Diluent） FOB Rapid Test Cassette (Colloidal Gold) 1T/box,10T/box,20T/box,25T/box,40T/box,50T/box98/79 FOB/TF Rapid Test Cassette(Colloidal Gold) 1T/box,10T/box,20T/box,25T/box,40T/box,50T/box98/79 3 others Lyse used for Hematology Analysis （Lyse） 500mL（HAS310/330/360/380 Lyse） Lyse used for Hematology Analysis(LH) 100ml 、250ml（SXHA610/650/660/680 LH Lyse） Lyse used for Hematology Analysis（DIFF） 500mL（SXHA610/650/660/680 DIFF Lyse）	A IVDR, 98/79	office@guoke-medical.com EUDAMED record Report an error
Capitalbiotech EU representative : SUNGO Europe B.V. (Netherlands)	China	DxLab-2A LuxScan 10K/A RTisochip-W RTisochipTM-A	A IVDR	EUDAMED record Report an error
Edan FDA EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)	China	Dye HF91D Dye HF92N Dye HF93R	A IVDR	EUDAMED record Report an error
NanoEntek FDA EU representative : Medical Technology Promedt Consulting GmbH (Germany)	South Korea	ADAM-rWBC Kit2 refs98/79 ADAMII-CD34 Kit ADAMII™-CD34 Kit98/79 ADAMII™-CD3/CD4/CD8 Kit98/79	– 98/79	Website eudamed@nanoentek.com EUDAMED record Report an error
Zybio FDA EU representative : Lotus NL B.V. (Netherlands)	China	H58 FD3 refs H58 FN3 refs H58 FR3 refs	A IVDR	PMS@zy-ivd.com EUDAMED record Report an error
Dirui FDA EU representative : SUNGO Europe B.V. (Netherlands)	China	BF-RF Dye3 refs DIRUI H-180098/79	A IVDR, 98/79	EUDAMED record Report an error
Pushkang EU representative : MedPath GmbH (Germany)	China	CRP Assay Kit98/79 SAA Assay Kit98/79	– 98/79	EUDAMED record Report an error
Sinseng EU representative : Sungo Cert GmbH (Germany)	China	HAS31098/79 SXHA61098/79	– 98/79	service@sinseng.com.cn EUDAMED record Report an error
Spinreact	Spain	DET-5 Detergent reagent Spincell 5 Series PROCLEAN Probe cleaner Spincell 3 and Spincell 5 series	A IVDR	Website EUDAMED record Report an error
Urit FDA EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)	China	BH-FD68 Fluorescent dye BH-FN68 Fluorescent dye	A IVDR	Website service@uritest.com EUDAMED record Report an error
Beckman Coulter FDA EU representative : Beckman Coulter Ireland Inc. (Ireland)	United States	CLENZ Solution98/79	– 98/79	Website EUDAMED record Report an error
Dana Tajhiz Aria EU representative : Medisol Technologies S.L. (Spain)	Iran	4DS DANA 4DS-LYSER	A IVDR	Website EUDAMED record Report an error
Diagon	Hungary	Defoamer	A IVDR	Website EUDAMED record Report an error
Dymind EU representative : Eunitor GmbH (Germany)	China	Hematology Analyzer Dye D-80FN(M) 6mL2 refs	A IVDR	regulationdept@dymind.com EUDAMED record Report an error
Dynodx EU representative : HUMISS TRADING S. L. (Spain)	China	DI-50	A IVDR	EUDAMED record Report an error
Horiba FDA	France	ABX Minoclair 0.5L 0401005	A IVDR	EUDAMED record Report an error
Nihon Kohden Firenze	Italy	Reticulonac Stain reagent	A IVDR	Website info@nkf.it EUDAMED record Report an error
Shenzhen Cinnaray Life Technology EU representative : HUMISS TRADING S. L. (Spain)	China	Architect-1, Architect-2, Alinity-1, Alinity-2, IM10, IM 11, BKM, XCY1, XCY2, AT-A, AT-B, MR, YHL-2, YHL-3, QS-A, QS-B, WG-A, WG-B3 refs	A IVDR	EUDAMED record Report an error
Shenzhen Zijian Biotechnology EU representative : CMC Medical Devices & Drugs SL (Spain)	China	Testing pack 1 Tests/Kit3 refs	A IVDR	Website sales@szzijian.com EUDAMED record Report an error
Sichuan Gonwing Biotechnology EU representative : Share info GmbH (Germany)	China	GONWING 1test/box, 5 tests/box, 10 tests/box, 20 tests/box, 50 tests/box, 100 tests/box, 200 tests/box3 refs	A IVDR	EUDAMED record Report an error
Siemens Healthcare Diagnostics FDA EU representative : Siemens Healthcare Diagnostics Manufacturing Limited (Ireland)	United States	ADVIA 120/2120/2120i CSF Reagent IVDR_67_TTN_DUB-C_B_REAG_CSF Reagent	B IVDR	Website contact@siemens-healthineers.com EUDAMED record Report an error
Sinocare FDA EU representative : Lotus NL B.V. (Netherlands)	China	iCARE-2100	A IVDR	RA@sinocare.com EUDAMED record Report an error
ZOVEC diagnostics	Germany	RapidHemo2 refs	A IVDR	Website 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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