Infectious diseasesInfectious immunology - rapid tests & point of careParasitology RT & POC

Plasmodium (malaria) - RT & POC

EMDN code W0105090401

70 manufacturers, 298 models including 289 on the market, 12 countries

On the market in Models on the market only Manufacturer country

Manufacturers registered in Europe (EUDAMED) 70

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
Abbott FDA EU representative : Emergo Europe B.V. (Netherlands) and 1 other	South Korea, United States	Alere™ Malaria Ag P.f 05FK14098/79 Alere™ Malaria Ag P.f 05FK14198/79 Alere™ Malaria Ag P.f 05FK14398/79 BinaxNOW™ Malaria (25T) 660-00098/79 BinaxNOW™ Malaria 6600598/79 22 others Bioline™ Malaria Ag P.f (HRP2/pLDH) 05FK9098/79 Bioline™ Malaria Ag P.f 05FK502 refs98/79 Bioline™ Malaria Ag P.f/P.f/P.v98/79 Bioline™ Malaria Ag P.f/P.f/P.v 05FK12098/79 Bioline™ Malaria Ag P.f/P.f/P.v 05FK12398/79 Bioline™ Malaria Ag P.f/P.v 05FK8098/79 Bioline™ Malaria Ag P.f/Pan 05FK602 refs98/79 Bioline™ Malaria Ag P.f/Pan 05FK6198/79 Bioline™ Malaria Ag P.f/Pan 05FK6398/79 NxTek™ Eliminate Malaria Pf 05FK14098/79 SD BIOLINE Malaria Ag P.f (HRP2/pLDH) 05FK9098/79 SD BIOLINE Malaria Ag P.f (HRP2/pLDH) 05FK9398/79 SD BIOLINE Malaria Ag P.f 05FK502 refs98/79 SD BIOLINE Malaria Ag P.f 05FK5398/79 SD BIOLINE Malaria Ag P.f./Pan 05FK602 refs98/79 SD BIOLINE Malaria Ag P.f./Pan 05FK612 refs98/79 SD BIOLINE Malaria Ag P.f./Pan 05FK6398/79 SD BIOLINE Malaria Ag P.f./Pan 05FK6798/79 SD BIOLINE Malaria Ag P.f/P.f/P.v 05FK12098/79 SD BIOLINE Malaria Ag P.f/P.f/P.v 05FK12398/79 SD BIOLINE Malaria Ag P.f/P.v 05FK8098/79 SD BIOLINE Malaria Ag P.f/P.v 05FK8298/79	– 98/79	Website EUDAMED record Report an error
Bioperfectus FDA EU representative : MedNet EC-REP GmbH (Germany) and 1 other	China	Malaria Pf (HRP2) Ag Rapid Test Kit3 refs Malaria Pf (HRP2) Ag Rapid Test Kit SC20102W-1T98/79 Malaria Pf (HRP2) Ag Rapid Test Kit SC20102W-20T98/79 Malaria Pf (HRP2) Ag Rapid Test Kit SC20102W-25T98/79 Malaria Pf (HRP2) Ag Rapid Test Kit SC20102W-50T98/79 14 others Malaria Pf (HRP2/pLDH) Ag Rapid Test Kit SC20204W-1T98/79 Malaria Pf (HRP2/pLDH) Ag Rapid Test Kit SC20204W-20T98/79 Malaria Pf (HRP2/pLDH) Ag Rapid Test Kit SC20204W-25T98/79 Malaria Pf (HRP2/pLDH) Ag Rapid Test Kit SC20204W-50T98/79 Malaria Pf/Pan (HRP2/pLDH) Ag Rapid Test Kit3 refs Malaria Pf/Pan (HRP2/pLDH) Ag Rapid Test Kit SC20202W-1T98/79 Malaria Pf/Pan (HRP2/pLDH) Ag Rapid Test Kit SC20202W-20T98/79 Malaria Pf/Pan (HRP2/pLDH) Ag Rapid Test Kit SC20202W-25T98/79 Malaria Pf/Pan (HRP2/pLDH) Ag Rapid Test Kit SC20202W-50T98/79 Malaria Pf/Pv (HRP2/pLDH) Ag Rapid Test Kit3 refs Malaria Pf/Pv (HRP2/pLDH) Ag Rapid Test Kit SC20203W-1T98/79 Malaria Pf/Pv (HRP2/pLDH) Ag Rapid Test Kit SC20203W-20T98/79 Malaria Pf/Pv (HRP2/pLDH) Ag Rapid Test Kit SC20203W-25T98/79 Malaria Pf/Pv (HRP2/pLDH) Ag Rapid Test Kit SC20203W-50T98/79	C IVDR, 98/79	EUDAMED record Report an error
Hangzhou Alltest Biotech FDA EU representative : MedNet EC-REP GmbH (Germany) and 1 other	China	Malaria Antibody Rapid Test IMAB-40298/79 Malaria P.f. /P.v. Rapid Test Cassette (Whole Blood) IMPV-40298/79 Malaria P.f. /P.v. Rapid Test Cassette IMPV-R40298/79 Malaria P.f. /P.v. Rapid Test IMPV-N402-203 refs Malaria P.f. /Pan Rapid Test Cassette (Whole Blood) IMPN-40298/79 13 others Malaria P.f. /Pan Rapid Test IMPN-N402-203 refs Malaria P.f. Rapid Test Cassette98/79 Malaria P.f. Rapid Test Cassette (Whole Blood) IMA-40298/79 Malaria P.f./P.v. /Pan Rapid Test Cassette IMPVF-40298/79 Malaria P.f./P.v. Rapid Test Cassette IMPV-40298/79 Malaria P.f./P.v. Rapid Test Dipstick98/79 Malaria P.f./P.v. Rapid Test IMPV-40198/79 Malaria P.f./P.v./Pan Rapid Test Cassette IMPVF-R40298/79 Malaria P.f./P.v./Pan Rapid Test Malaria Test Cassette IMPVF-40298/79 Malaria P.f./P.v./Pan Rapid Test Malaria Test IMPVF-40298/79 Malaria P.f./Pan Rapid Test Cassette IMPN-R40298/79 Malaria P.f./Pan Rapid Test Dipstick98/79 Malaria P.f./Pan Rapid Test IMPN-40198/79	C IVDR, 98/79	info@alltests.com.cn EUDAMED record Report an error
Vitrosens	Türkiye	ChainFor Malaria Detection qPCR Kit CFP9898/79 ChainFor™3 refs ChainFor™ CFP69P10098/79 LyoSens™ LYO69WS2498/79 RapidFor™3 refs 9 others RapidFor™ Malaria P.f. (HRP2) Rapid Test Kit VMD2098/79 RapidFor™ Malaria P.f. (pLDH) Rapid Test Kit VMD12798/79 RapidFor™ Malaria P.f. pLDH/HRP2 Test Kit RapidFor™ VMD21BD98/79 RapidFor™ VMD22BDLA98/79 RapidFor™ VMD28BDLA98/79 RapidFor™ VMPO73EP98/79 RapidFor™ VMPO74ED98/79 RapidFor™ VMPO74EP98/79	C IVDR, 98/79	Website info@vitrosens.com EUDAMED record Report an error
Safecare FDA EU representative : UnicareQ GmbH (Germany) and 1 other	China	Malaria P.f. Rapid Test (Whole Blood) MAL-4011a/MAL-4012a98/79 Malaria P.v. Rapid Test (Whole Blood) MAL-4011b/MAL-4012b98/79 Malaria P.f. Rapid Test Kit(Whole Blood) MAL-4011/MAL-4012a98/79 Malaria P.f./P.v. Rapid Test Kit(Whole Blood) MAL-4022a98/79 Malaria P.f./P.v. Rapid Test (Whole Blood) MAL-4022a98/79 4 others Malaria P.f./Pan Rapid Test Kit(Whole Blood) MAL-4022b98/79 Malaria P.f./Pan Rapid Test (Whole Blood) MAL-4022b98/79 Malaria P.v./Pan Rapid Test (Whole Blood) MAL-4022c98/79 Malaria Pan Rapid Test (Whole Blood) MAL-4011c/MAL-4012c98/79	– 98/79	EUDAMED record Report an error
HangZhou Biotest Biotech FDA EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)	China	Cassette IMAL-C5398/79 Rightsign IMAL-C5398/79 Rightsign IMPF-C5198/79 Rightsign IMPF-C51S98/79 Rightsign IMPN-C5298/79 3 others Rightsign IMPN-C52S98/79 Rightsign IMPV-C5298/79 Rightsign IMPV-C52S98/79	– 98/79	info@biotests.com.cn EUDAMED record Report an error
Hangzhou Laihe Biotech FDA EU representative : SUNGO Europe B.V. (Netherlands)	China	LYHER IMA-402-0198/79 LYHER IMA-402-0298/79 LYHER IMA-402-0598/79 LYHER IMA-402-0798/79 LYHER IMA-402-2098/79 3 others LYHER IMA-402-2598/79 LYHER IMA-402-4098/79 Malaria Antigen Test Kit98/79	– 98/79	office@lyher.com EUDAMED record Report an error
Acro Biotech FDA EU representative : MedNet EC-REP GmbH (Germany) and 1 other	United States	Malaria Antibody Rapid Test IMAB-ACO40298/79 Malaria P.f. /P.v. Rapid Test Cassette (Whole Blood) IMPV-R40298/79 Malaria P.f. Rapid Test Cassette (Whole Blood) IMA-R40298/79 Malaria P.f./P.v. /Pan Rapid Test Cassette MFVP2D98/79 Malaria P.f./P.v./Pan Rapid Test Cassette acrMPVF402R98/79 2 others Malaria P.f./P.v./Pan Rapid Test Cassette IMPVF-40298/79 Malaria P.f./Pan Rapid Test Cassette (Whole Blood) IMPN-R40298/79	– 98/79	info@acrobiotech.com EUDAMED record Report an error
Assure Tech. (Hangzhou) EU representative : CMC Medical Devices & Drugs SL (Spain) and 1 other	China	Device A4343011 Device A4347011 Device A4353011 Device A4357011 Malaria P.f Rapid Test Mal pf-W11M, Mal pf-W23M98/79 2 others Malaria P.f/Pan Rapid Test Mal pf/pan-W11M,Mal pf/pan-W23M98/79 Malaria pf/pv Rapid Test Mal pf/pv-W11M, Mal pf/pv-W23M98/79	C IVDR, 98/79	Website contact@diareagent.com EUDAMED record Report an error
Acesolab FDA EU representative : VidaQuick Biotech S.L. (Spain)	United States	Malaria P.f. Test B01-MAL98/79 Malaria P.f. Test B02-MAL98/79 Malaria P.f./ P.v. /Pan Test B02-MPVF98/79 Malaria P.f./ P.v. Test B02-MPV98/79 Malaria P.f./ Pan Test B02-MPN98/79 1 other Malaria P.f./P.v./Pan FIA Test98/79	– 98/79	info@acesolab.com EUDAMED record Report an error
Ameritech Diagnostic Reagent (Jiaxing) EU representative : CEpartner4U (Netherlands)	China	R10-11098/79 R10-11698/79 R11-11098/79 R11-11698/79 R13-11098/79 1 other R13-11698/79	– 98/79	EUDAMED record Report an error
Healgen FDA EU representative : CMC Medical Devices & Drugs SL (Spain)	United States	Malaria P.f./P.v. Ag Rapid Test Cassette (Whole Blood) GCMAL(pf/pv)-402a98/79 Malaria P.f./Pan Ag Rapid Test Cassette (Whole Blood) GCMAL(pf/pan)-402a98/79 Malaria Pan Ag Rapid Test Cassette (Whole Blood) GCMAL(pan)-402a98/79 Malaria Pf Ag Rapid Test Cassette (Whole Blood) GCMAL(Pf)-402a98/79 Malaria Pf/Pv Ab Rapid Test Cassette (Serum/Plasma) GCMAL(pf/pv Ab)-302a98/79 1 other Malaria Pf/Pv Ab Rapid Test Cassette (whole blood/serum/plasma) GCMAL(pf/pv Ab)-402a98/79	– 98/79	quality@healgen.com EUDAMED record Report an error
Nexlab EU representative : MedNet EC-REP GmbH (Germany)	China	POCBio Malaria Pf Rapid Test LATT03-C2598/79 POCBio Malaria Pf Rapid Test LATT03-C5098/79 POCBio Malaria Pf/Pan Rapid Test LATT05-C2598/79 POCBio Malaria Pf/Pan Rapid Test LATT05-C5098/79 POCBio Malaria Pf/Pv Rapid Test LATT04-C2598/79 1 other POCBio Malaria Pf/Pv Rapid Test LATT04-C5098/79	– 98/79	EUDAMED record Report an error
Orientgene FDA EU representative : CMC Medical Devices & Drugs SL (Spain) and 1 other	China	Malaria P.f. Ag Rapid Test Casssette (Whole Blood) GCMAL(pf)-402a98/79 Malaria P.f./P.v. Ag Rapid Test Cassette (Whole Blood) GCMAL(pf/pv)-402a98/79 Malaria P.f./Pan Ag Rapid Test Cassette (Whole Blood) GCMAL(pf/pan)-402a98/79 Malaria Pan Ag Rapid Test Cassette (Whole Blood) GCMAL(pan)-402a98/79 Malaria Pf/Pv Ab Rapid Test Cassette (Serum/Plasma) GCMAL(pf/pv Ab)-302a98/79 1 other Malaria Pf/Pv Ab Rapid Test Cassette (whole blood/serum/plasma) GCMAL(pf/pv Ab)-402a98/79	– 98/79	EUDAMED record Report an error
Tongzhoubio FDA EU representative : VidaQuick Biotech S.L. (Spain)	China	Malaria P.f. Rapid Test I039-400198/79 Malaria P.f. Rapid Test I039-400298/79 Malaria P.f./ Pan Rapid Test I040-400298/79 Malaria P.f./P.v. Rapid Test I041-400298/79 Malaria P.f./P.v./Pan Rapid Test I042-400298/79 1 other Malaria P.f./P.v./Pan Test Kit YI063-403598/79	– 98/79	EUDAMED record Report an error
Türklab Tibbi̇ Mlz. San. Ve Ti̇c. Aş	Türkiye	Malaria Test IML0198/79 Malaria Test RTML0198/79 Malaria Test TIML0198/79 Malaria Test TIML0100198/79 Malaria Test TIML0101098/79 1 other Malaria Test TML0198/79	– 98/79	Website info@turklab.com.tr EUDAMED record Report an error
Vivachek FDA EU representative : CMC Medical Devices & Drugs SL (Spain) and 1 other	China	Malaria P.f. Rapid Test VIMPf98/79 Malaria P.f./P.v. Rapid Test VIMPfv98/79 Malaria P.f./P.v. Rapid Test VIMPfv-22698/79 Malaria P.f./P.v./Pan Rapid Test VIMP98/79 Malaria P.f./Pan Rapid Test VIMP98/79 1 other Malaria P.v. Rapid Test VIMPv98/79	– 98/79	info@vivachek.com EUDAMED record Report an error
Wuhan Life Origin Biotech Joint Stock EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain)	China	Plasmodium Falciparum Antigen Detection Kit (Colloidal Gold) 1 test/kit98/79 Plasmodium Falciparum Antigen Detection Kit (Colloidal Gold) 10 tests/kit98/79 Plasmodium Falciparum Antigen Detection Kit (Colloidal Gold) 100 tests/kit98/79 Plasmodium Falciparum Antigen Detection Kit (Colloidal Gold) 25 tests/kit98/79 Plasmodium Falciparum Antigen Detection Kit (Colloidal Gold) 5 tests/kit98/79 1 other Plasmodium Falciparum Antigen Detection Kit (Colloidal Gold) 50 tests/kit98/79	– 98/79	EUDAMED record Report an error
AccuBioTech EU representative : MDSS GmbH (Germany)	China	Accu-Tell® Malaria P.f. Cassette(Whole Blood)98/79 Accu-Tell® Malaria P.f./P.v. Cassette(Whole Blood)98/79 Accu-Tell®Malaria p.f./p.v./pan Cassette(Whole Blood)98/79 Accu-Tell®Malaria P.f./Pan Cassette(Whole Blood)98/79 Accu-Tell®Malaria P.f./Pan Strip(Whole Blood)98/79	– 98/79	sales@accubiotech.com EUDAMED record Report an error
Actest EU representative : VidaQuick Biotech S.L. (Spain)	China	Malaria P.f. /Pan Rapid Test Cassetle98/79 Malaria P.f. Rapid Test Cassette MAF-2-D98/79 Malaria P.f. Rapid Test Dipstick98/79 Malaria P.f./P.v. /Pan Rapid Test Cassette MAFVN-2-D98/79 Malaria P.f./P.v. Rapid Test Cassette MAFV-2-D98/79	– 98/79	info@actest.com.cn EUDAMED record Report an error
Bitrumed EU representative : VidaQuick Biotech S.L. (Spain)	China	Malaria P.f. Test MAL-4A198/79 Malaria P.f. Test MAL-4C198/79 Malaria P.f./ P.v. /Pan Test MPVF-4C198/79 Malaria P.f./ P.v. Test MPV-4C198/79 Malaria P.f./ Pan Test MPN-4C198/79	– 98/79	info@bitrumed.com.cn EUDAMED record Report an error
Zhejiang Greylynx Biotech EU representative : Lotus NL B.V. (Netherlands)	China	Malaria P.f. Rapid Test GIMALf98/79 Malaria P.f./P.v. Rapid Test GIMALfv98/79 Malaria P.f./P.v./Pan Rapid Test GIMP98/79 Malaria P.f./Pan Rapid Test GIMALfa98/79 Malaria Pf/Pan Ag 4 Species Rapid Test GIMAL498/79	– 98/79	info@vivachek.com EUDAMED record Report an error
Anhui Deepblue Medical Technology FDA EU representative : Luxus Lebenswelt GmbH (Germany)	China	Malaria pf Test Kit Cassette98/79 Malaria pf/pan Test Kit Cassette98/79 Malaria pf/pv Test Kit Cassette4 refs98/79 Malaria pf/pv Test Kit Strip98/79	– 98/79	sales@dbluemedical.com EUDAMED record Report an error
Avioq Bio-tech EU representative : Lotus NL B.V. (Netherlands)	China	1 Test/Kit98/79 20 Tests/Kit98/79 25 Tests/Kit98/79 40 Tests/Kit98/79	– 98/79	EUDAMED record Report an error
Bgi	Denmark	BGI 10 tests/kit2 refs98/79 BGI 25 tests/kit2 refs98/79 BGI 5 tests/kit2 refs98/79 BGI 50 tests/kit2 refs98/79	– 98/79	Website EUDAMED record Report an error
Bosonbio FDA EU representative : Lotus NL B.V. (Netherlands)	China	Rapid Malaria pan Antigen Test Card 1Q05C298/79 Rapid Malaria pf Antigen Test Card 1Q06C298/79 Rapid Malaria pf/pan Antigen Test Card 1Q10C298/79 Rapid Malaria pf/pv Antigen Test Card 1Q07C298/79	– 98/79	Website EUDAMED record Report an error
Clongene FDA EU representative : HUMISS TRADING S. L. (Spain) and 1 other	China	Malaria P.f Antigen Rapid Test Cassette (WB) IPFGi00298/79 Malaria P.f/P.v Antigen Rapid Test Cassette (WB) IFVGi2198/79 Malaria P.f/Pan Antigen Rapid Test Cassette (WB) IFPGi212, IFPGi21898/79 Malaria Pan Antigen Rapid Test Cassette (WB) IPANi00298/79	– 98/79	Website marketing@clongene.com EUDAMED record Report an error
Genesignbio EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain) and 1 other	China	1 test/kit3 refs98/79 25 tests/kit3 refs98/79 GeneSign Malaria P.f/P.v Ab Rapid Test 1 test/kit98/79 GeneSign Malaria P.f/P.v Ab Rapid Test 25 tests/kit98/79	– 98/79	info@genesignbio.com EUDAMED record Report an error
Medotexbio EU representative : Llins Service & Consulting GmbH (Germany)	China	Malaria P.f. Rapid Test MAL-402b Malaria P.f./P.v. Rapid Test MALV-422b Malaria P.f./Pan Rapid Test MALN-422b MALV-422b98/79	C IVDR, 98/79	Website EUDAMED record Report an error
Newlink Biotech EU representative : VidaQuick Biotech S.L. (Spain)	China	Malaria P.f. Rapid Test L11-MAF01A498/79 Malaria P.f./P.v. /Pan Rapid Test L11-MPVF01C498/79 Malaria P.f./P.v./Pan Assay F11-MAL01C498/79 One Step Malaria Antibody Test98/79	– 98/79	Website info@kylinew.com EUDAMED record Report an error
Aichek FDA EU representative : Medunion S.L. (Spain)	China	Malaria P.f. Antigen Rapid Test MAL-D02a98/79 Malaria P.f./P.an. Rapid Test MAL-D22a98/79 Malaria P.f./P.v. Rapid Test MAL-D22b98/79	– 98/79	ra.rep@aichek.com EUDAMED record Report an error
Dezhou Guoke Medical Technology EU representative : MedPath GmbH (Germany)	China	Malaria P.f/P.v Ag Rapid Test Kit GKPD11498/79 Plasmodium falciparum and Pan-plasmodium Antigen Detection Kit (Immunofluorescence Chromatography)98/79 Plasmodium falciparum and Plasmodium vivax Antigen Detection Kit (Immunofluorescence Chromatography)98/79	– 98/79	office@guoke-medical.com EUDAMED record Report an error
InTec PRODUCTS EU representative : QbD RepS BV (Belgium)	China	ONE STEP Malaria(p.f.) Test ITP110022 refs98/79 ONE STEP Malaria(p.f/p.v) Tri-line Test ITP110032 refs98/79 Rapid Malaria Test (P.f/Pan) ITP110052 refs98/79	– 98/79	Website EUDAMED record Report an error
nal von minden	Germany	Lagaay Malaria Pf/Pan Ag 4 Species Test Malaria Pf/Pan Ag 4 SpeciesTest98/79 NADAL® Malaria Pf/Pan Ag 4 Species plus Test3 refs98/79 NADAL® Malaria Pf/Pan Ag 4 Species Test2 refs98/79	– 98/79	Website info@nal-vonminden.com EUDAMED record Report an error
Nano Diagnosis for Health Biotech (Guangzhou) EU representative : MedPath GmbH (Germany)	China	Malaria P.f./P.v. Rapid Test MALAC1-0298/79 Malaria P.f./P.v./Pan Rapid Test MALAC3-0298/79 Malaria P.f./Pan Rapid Test MALAC2-0298/79	– 98/79	EUDAMED record Report an error
Rapid Labs EU representative : Advena Limited (Malta) and 1 other	United Kingdom (ex Northern Ireland)	Malaria P.f./P.v./Pan Rapid Test Device – WB98/79 Malaria P.f./P.v./Pan Test Device--WB2 refs98/79 Malaria Pf Rapid Test Strip – WB98/79	– 98/79	Website info@rapidlabs.co.uk EUDAMED record Report an error
Sejoy FDA EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)	China	Malaria P.f ＆P.v Rapid Test (Whole Blood) Cassette98/79 Malaria P.f ＆Pan Rapid Test (whole blood) Cassette98/79 Malaria Plasmodium Falciparum Rapid Test (whole blood) Cassette98/79	– 98/79	Website EUDAMED record Report an error
Shenzhen Zijian Biotechnology EU representative : Lotus NL B.V. (Netherlands)	China	Malaria Pf/Pv Antigen Rapid Test Kit(Lateral Flow Method) 100 Tests/kit98/79 Malaria Pf/Pv Antigen Rapid Test Kit(Lateral Flow Method) 25 Tests/kit98/79 Malaria Pf/Pv Antigen Rapid Test Kit(Lateral Flow Method) 50 Tests/kit98/79	– 98/79	Website sales@szzijian.com EUDAMED record Report an error
Wizbiotech EU representative : QbD RepS BV (Belgium)	China	Malaria (P.F) Rapid Test (Colloidal Gold)98/79 Malaria P.F/P.V Rapid Test (Colloidal Gold)98/79 Malaria P.F/Pan Rapid Test(Colloidal Gold)98/79	– 98/79	EUDAMED record Report an error
Xenta Biomedical Science FDA EU representative : CMC Medical Devices & Drugs SL (Spain)	China	Malaria Antigen P.f Detection Reagent (Colloidal Gold method)2 refs98/79 Malaria Antigen P.f/P.v Detection Reagent (Colloidal Gold method)2 refs98/79 Malaria Antigen P.f/Pan Detection Reagent (Colloidal Gold method)2 refs98/79	– 98/79	Website EUDAMED record Report an error
Aconbio EU representative : MedNet EC-REP GmbH (Germany)	China	Flowflex98/79 Quik-Check2 refs98/79	– 98/79	Website EUDAMED record Report an error
Atlas Medical FDA	Germany	Atlas 8.04.37.0.002098/79 Atlas Malaria PF/PV , test cassette, Whole blood, Individually packed, 20 Test/Box 8.16.14.0.002098/79	– 98/79	Website info@atlas-medical.com EUDAMED record Report an error
Biobase FDA EU representative : Luxus Lebenswelt GmbH (Germany)	China	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
Gensurebio EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain)	China	Malaria P.f/P.v Antigen Rapid Test P204098/79 Malaria Pf/Pan Rapid Test P204198/79	– 98/79	Website info@gensurebio.com EUDAMED record Report an error
HEALSTONE Biotech FDA EU representative : CMC Medical Devices & Drugs SL (Spain)	Canada	Malaria P.f./P.v. Ag Rapid Test Cassette (Whole Blood) GCMAL(pf/pv)-402a98/79 Malaria P.f./Pan Ag Rapid Test Cassette (Whole Blood) GCMAL(pf/pan)-402a98/79	– 98/79	sales@orientgene.com EUDAMED record Report an error
Hightopbio FDA EU representative : MedNet EC-REP GmbH (Germany)	China	Malaria P.f (HRP2, pLDH) Rapid Test98/79 Malaria P.f/P.v/Pan Rapid Test H1433-41W98/79	– 98/79	Website EUDAMED record Report an error
Labnovation EU representative : MedNet EC-REP GmbH (Germany)	China	Malaria P.f (HRP-2) Antigen Rapid Test Kit (Immunochromatography) 20 Tests/Kit98/79 Malaria P.f (HRP-2)/P.v (LDH)/Pan (LDH) Antigen Rapid Test Kit (Immunochromatography) 20 Tests/Kit98/79	– 98/79	Website info@labnovation.com EUDAMED record Report an error
Shenzhen Chenghui Medical Technology EU representative : HUMISS TRADING S. L. (Spain)	China	Malaria Pathogen Nucleic Acid Detection Kit 1.198/79 Malaria Pathogen Nucleic Acid Detection Kit 2.198/79	– 98/79	EUDAMED record Report an error
Vi̇si̇on Bi̇yoteknoloji̇ Araştirma Geli̇şti̇rme Laboratuvar Si̇stemleri̇ Sanayi̇ Ve Ti̇caret Şi̇rketi̇	Türkiye	MALARYA Pf/Pv/Pan HIZLI TEST KİTİ Sıtma Pf Hızlı Test Kiti	C IVDR	Website info@visionbiotechnology.com EUDAMED record Report an error
Zhejiang QL Biotech EU representative : CMC Medical Devices & Drugs SL (Spain)	China	QINGLI Device:20 Test/Kit4 refs98/79 QINGLI Strip: 25Tests/Kit98/79	– 98/79	EUDAMED record Report an error
Arkray FDA EU representative : Arazy Group GmbH (Germany)	India	PARAHIT-F VER. 1.0 Rapid Test for P. falciparum Malaria Device	C IVDR	Website EUDAMED record Report an error
BioFynder EU representative : SUNGO Europe B.V. (Netherlands)	United Kingdom (ex Northern Ireland)	TruVue3 refs98/79	– 98/79	EUDAMED record Report an error
Biomaxima	Poland	Malaria P.f./Pan 1-352-K02098/79	– 98/79	Website info@biomaxima.com EUDAMED record Report an error
Biopanda	Northern Ireland	Malaria P.f. Rapid Test Cassette RAPG-MLR-00198/79	– 98/79	Website info@biopanda.co.uk EUDAMED record Report an error
Coyotebio EU representative : CMC Medical Devices & Drugs SL (Spain)	China	FlashDetect98/79	– 98/79	sales@coyotebio.com EUDAMED record Report an error
Genes2Me EU representative : Obelis s.a. (Belgium)	India	Malaria-Q Real-Time PCR Kit G2M70622198/79	– 98/79	Website EUDAMED record Report an error
Hangzhou Zhunxin Biotechnology EU representative : CMC Medical Devices & Drugs SL (Spain)	China	HA-01298/79	– 98/79	EUDAMED record Report an error
Hysenbiotech EU representative : Medunion S.L. (Spain)	South Korea	Malaria P.f./Pan Rapid Test Cassette HIMPN-40298/79	– 98/79	EUDAMED record Report an error
Kalians EU representative : MDSS GmbH (Germany)	Egypt	Malaria Antigen Test (Whole Blood) For Plasmodium falciparum & vivax98/79	– 98/79	EUDAMED record Report an error
Lifotronic FDA EU representative : Umedwings Netherlands B.V. (Netherlands)	China	Malaria P.f/Pan Test (GICA) 25T98/79	– 98/79	Website EUDAMED record Report an error
Lysunbio FDA EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain)	China	LYSUN MAL-W21- FV（25PCS）98/79	– 98/79	EUDAMED record Report an error
Microprofit EU representative : CMC Medical Devices & Drugs SL (Spain)	China	Malaria Pf/ Pv Antigen Test Kit (Immunochromatographic Assay)2 refs98/79	– 98/79	EUDAMED record Report an error
Shenzhen Huian Biosci Technology EU representative : SUNGO Europe B.V. (Netherlands)	China	20T/Kit2 refs98/79	– 98/79	info@huiantech.com EUDAMED record Report an error
Spectrum For Diagnostic Industries Joint Stock EU representative : MDSS GmbH (Germany)	Egypt	Malaria Antigen Test Card2 refs98/79	– 98/79	Website EUDAMED record Report an error
Zetmedikal	Türkiye	SOFTEC Malaria P.f/P.v Rapid Test Kit98/79	– 98/79	Website info@zetmedikal.com EUDAMED record Report an error
Zhongshan Bio-Tech EU representative : Lotus NL B.V. (Netherlands)	China	25 tests/kit3 refs98/79	– 98/79	EUDAMED record Report an error
Hangzhou Genesis Biodetection Biocontrol FDA EU representative : Lotus NL B.V. (Netherlands) No model still on the market	China	Malaria Pf Antigen Rapid Test Device P23110798/79 (no longer marketed) Malaria Pf/Pan Antigen Rapid Test Device P23110998/79 (no longer marketed) Malaria Pf/Pv Antigen Rapid Test Device P23110898/79 (no longer marketed)	– 98/79	Website EUDAMED record Report an error
Nantong EgensBiotechnology FDA EU representative : SUNGO Europe B.V. (Netherlands) No model still on the market	China	Diagnostic Kit for P.falciparum /P.vivax Antigen(Colloidal Gold) MA-Pf/Pv strip cassette98/79 (no longer marketed) Diagnostic Kit for P.falciparum Antigen （Colloidal Gold) MA-Pf strip cassette98/79 (no longer marketed) Diagnostic Kit for Pan/ P.falciparum Antigen (Colloidal Gold) MA-Pan/Pf strip cassette98/79 (no longer marketed)	– 98/79	qa@egens-bio.cn EUDAMED record Report an error
Zhejiang Anji Saianfu Biotechnology EU representative : Lotus NL B.V. (Netherlands) No model still on the market	China	Malaria pf/pan One Step Rapid Test98/79 (no longer marketed) Malaria pf/pv One Step Rapid Test98/79 (no longer marketed)	– 98/79	EUDAMED record Report an error
SD Biosensor FDA EU representative : Medical Technology Promedt Consulting GmbH (Germany) No model still on the market	India	STANDARD Q Malaria P.f/P.v Ag RK025-40 (no longer marketed)	C IVDR	Website EUDAMED record Report an error

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