ReagentsInfectious diseasesInfectious immunology - rapid tests & point of care

Coronavirus RT & POC

EMDN code W01050905

59 manufacturers, 251 models including 240 on the market, 10 countries

On the market in Models on the market only Manufacturer country

Manufacturers registered in Europe (EUDAMED) 59

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
Wuhan Life Origin Biotech Joint Stock EU representative : SUNGO Europe B.V. (Netherlands)	China	COVID-19 Antigen Rapid Test Kit （Saliva) 1 test/kit98/79 COVID-19 Antigen Rapid Test Kit （Saliva) 10 tests/kit98/79 COVID-19 Antigen Rapid Test Kit （Saliva) 100 tests/kit98/79 COVID-19 Antigen Rapid Test Kit （Saliva) 25 tests/kit98/79 COVID-19 Antigen Rapid Test Kit （Saliva) 5 tests/kit98/79 17 others COVID-19 Antigen Rapid Test Kit （Saliva) 50 tests/kit98/79 COVID-19 Antigen Rapid Test Kit （Saliva) 7 tests/kit98/79 SARS-CoV -2 Neutralizing Antibody Assay Kit (Colloidal Gold) 1 test/kit98/79 SARS-CoV -2 Neutralizing Antibody Assay Kit (Colloidal Gold) 100 tests/kit98/79 SARS-CoV -2 Neutralizing Antibody Assay Kit (Colloidal Gold) 25 tests/kit98/79 SARS-CoV -2 Neutralizing Antibody Assay Kit (Colloidal Gold) 50 tests/kit98/79 SARS-CoV-2 Antigen Assay Kit (Immunochromatography) 1 test/kit98/79 SARS-CoV-2 Antigen Assay Kit (Immunochromatography) 10 tests/kit98/79 SARS-CoV-2 Antigen Assay Kit (Immunochromatography) 100 tests/kit98/79 SARS-CoV-2 Antigen Assay Kit (Immunochromatography) 25 tests/kit98/79 SARS-CoV-2 Antigen Assay Kit (Immunochromatography) 5 tests/kit98/79 SARS-CoV-2 Antigen Assay Kit (Immunochromatography) 50 tests/kit98/79 SARS-CoV-2 Antigen Assay Kit (Immunochromatography) SF24007298/79 SARS-CoV-2 Neutralizing Antibody Assay Kit (Immunochromatography) 1 test/kit98/79 SARS-CoV-2 Neutralizing Antibody Assay Kit (Immunochromatography) 100 tests/kit98/79 SARS-CoV-2 Neutralizing Antibody Assay Kit (Immunochromatography) 25 tests/kit98/79 SARS-CoV-2 Neutralizing Antibody Assay Kit (Immunochromatography) 50 tests/kit98/79	– 98/79	EUDAMED record Report an error
Hangzhou Alltest Biotech FDA EU representative : MedNet EC-REP GmbH (Germany) and 1 other	China	AUTOTESTE COVID-19 Ag(SALIVA)98/79 COVID-19 Antigen Rapid Test6 refs98/79 COVID-19 Antigen Rapid Test (Oral Fluid)98/79 COVID-19 Antigen Rapid Test Cassette(Oral Fluid)98/79 COVID-19 Antigen Rapid Test(Nasopharyngeal Swab)98/79 12 others COVID-19 Antigen Rapid Test-ITA98/79 COVID-19 Antigen Test Cassette(Swab)98/79 COVID-19 IgG/IgM Rapid Test2 refs98/79 SARS-CoV-2 (COVID-19) Antigen Rapid Test (Saliva)2 refs98/79 SARS-CoV-2 Antigen Rapid Test2 refs98/79 SARS-CoV-2 Antigen Rapid Test (Swab)98/79 SARS-CoV-2 Neutralization Antibody Rapid Test98/79 SARS-CoV-2 S-RBD Antibody Rapid Test98/79 SARS-CoV-2 S-RBD IgG Antibody Rapid Test2 refs98/79 SARS-COV-2(COVID-19) Antigen Rapid Test2 refs98/79 SARS-CoV-2-Antigen-Schnelltest (Nasenabstrich)98/79 Test Rapide de l’antigène SARS-CoV-2 (écouvillon nasal)98/79	– 98/79	info@alltests.com.cn EUDAMED record Report an error
Healgen FDA EU representative : CMC Medical Devices & Drugs SL (Spain) and 1 other	United States	Coronavirus Ag Rapid Test Cassette (Swab) GCCOV-502a98/79 Coronavirus Ag Rapid Test Cassette (Swab) GCCOV-502a-NA98/79 Coronavirus Ag Rapid Test Cassette (Swab) GCCOV-502a-NN98/79 COVID-19 Ag & B.1.1.7 Mutant Strain Combo Test Cassette (Swab) GCCOV(B117)-525a98/79 COVID-19 Ag Rapid Test Cassette (Oral Fluid) GCCOV-702a98/79 8 others COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) GCCOV-402a98/79 COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) GCCOV-402Ba98/79 Digital COVID-19 Ag Rapid Test (Swab) GCCOV-D503a98/79 Rapid COVID-19 Antigen Test Strip GCCOV-501a98/79 SARS-CoV-2 Ag Fluorescence Rapid Test Cassette (Swab) FCCOV-502a98/79 SARS-CoV-2 Delta-series Mutant Strain Ag Rapid Test Cassette (Swab) GCCOV(Del)-T502a98/79 SARS-CoV-2 Neutralizing Antibody Rapid Test Cassette (Whole Blood/Serum/Plasma) GCCOV(NAb)-402b98/79 Smart Rapid COVID-19 Ag Test Device GCCOV-503a98/79	– 98/79	quality@healgen.com EUDAMED record Report an error
Newlink Biotech EU representative : VidaQuick Biotech S.L. (Spain)	China	COVID-19 Antigen Assay98/79 COVID-19 S-RBD IgG Quantitative Assay98/79 One Step SARS-CoV-2 Antigen Test2 refs98/79 One Step SARS-CoV-2 Antigen Test (Oral Fluid)98/79 One Step SARS-CoV-2 IgG Test2 refs98/79 8 others One Step SARS-CoV-2 IgG/IgM Test2 refs98/79 One Step SARS-CoV-2 Neutralization Antibody Test98/79 SARS-CoV-2 Antigen Assay98/79 SARS-CoV-2 IgG/IgM Assay98/79 SARS-CoV-2 Rapid Antigen Test98/79 SARS-CoV-2 Rapid Antigen Test (Oral Fluid)98/79 SARS-CoV-2 S-RBD IgG Antibody Assay98/79 SARS-CoV-2 S-RBD IgG Antibody Rapid Test98/79	– 98/79	Website info@kylinew.com EUDAMED record Report an error
Orientgene FDA EU representative : CMC Medical Devices & Drugs SL (Spain) and 1 other	China	Coronavirus Ag Rapid Test Cassette (Swab) GCCOV-502a98/79 Coronavirus Ag Rapid Test Cassette (Swab) GCCOV-502a-NA98/79 Coronavirus Ag Rapid Test Cassette (Swab) GCCOV-502a-NN98/79 COVID-19 Ag & B.1.1.7 Mutant Strain Combo Test Cassette (Swab) GCCOV(B117)-525a98/79 COVID-19 Ag Rapid Test Cassette (Oral Fluid) GCCOV-702a98/79 8 others COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) GCCOV-402a98/79 COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) GCCOV-402Ba98/79 Digital COVID-19 Ag Rapid Test (Swab) GCCOV-D503a98/79 Rapid COVID-19 Antigen Test Strip GCCOV-501a98/79 SARS-CoV-2 Ag Fluorescence Rapid Test Cassette (Swab)98/79 SARS-CoV-2 Delta-series Mutant Strain Ag Rapid Test Cassette (Swab) GCCOV(Del)-T502a98/79 SARS-CoV-2 Neutralizing Antibody Rapid Test Cassette(Whole Blood/Serum/Plasma) GCCOV(NAb)-402b98/79 Smart Rapid COVID-19 Ag Test Device GCCOV-503a98/79	– 98/79	EUDAMED record Report an error
Tongzhoubio FDA EU representative : VidaQuick Biotech S.L. (Spain)	China	2019-nCoV IgG/IgM Rapid Test98/79 Coronavirus (SARS-CoV-2) Ag Self Test98/79 COVID-19 Antigen Test Kit98/79 COVID-19 S-RBD IgG Antibody Test Kit98/79 SARS-CoV-2 Antigen Test-Saliva98/79 5 others SARS-CoV-2 Antigen Test2 refs98/79 SARS-CoV-2 IgG Rapid Test98/79 SARS-CoV-2 Neutralization Antibody Rapid Test98/79 SARS-CoV-2 NPAb and NAb Combo Rapid Test98/79 SARS-CoV-2 S-RBD IgG Antibody Rapid Test98/79	– 98/79	EUDAMED record Report an error
Mpbio FDA	Germany	Rapid 2019-nCoV IgG/IgM Combo Test Card98/79 Rapid SARS-CoV-2 Antigen Test Card2 refs98/79 Rapid SARS-CoV-2 Antigen Test Card (1 Test Box)98/79 Rapid SARS-CoV-2 Antigen Test Card (1 test per box NL)98/79 Rapid SARS-CoV-2 Antigen Test Card (20 tests per box)98/79 4 others Rapid SARS-CoV-2 Antigen Test Card (5 tests per box)98/79 Rapid SARS-CoV-2 Antigen Test Card (5 tests per box, NL)98/79 Rapid SARS-CoV-2 Antigen Test Card (7 tests per box)98/79 Rapid SARS-CoV-2 Antigen Test Card (8 tests per box)98/79	– 98/79	Website EUDAMED record Report an error
Acro Biotech FDA EU representative : MedNet EC-REP GmbH (Germany) and 1 other	United States	COVID-19 Antigen Rapid Test (Oral Fluid)98/79 COVID-19 IgG Rapid Test (Whole Blood/Serum/Plasma)98/79 COVID-19 IgG/IgM Rapid Test (Whole Blood/Serum/Plasma)98/79 COVID-19 Nab Rapid Test (Whole Blood/Serum/Plasma)98/79 COVID-19 S-RBD Ab Rapid Test (Whole Blood/Serum/Plasma)98/79 3 others SARS-CoV-2 (COVID-19) Antigen Rapid Test (Swab)98/79 SARS-CoV-2 Neutralization Antibody Rapid Test (Whole Blood/Serum/Plasma)98/79 SARS-CoV-2 S-RBD IgG Antibody Rapid Test (Whole Blood/Serum/Plasma)98/79	– 98/79	info@acrobiotech.com EUDAMED record Report an error
Acesolab FDA EU representative : VidaQuick Biotech S.L. (Spain)	United States	COVID-19 Antigen FIA Test98/79 COVID-19 IgG/IgM FIA Test98/79 COVID-19 S-RBD IgG Antibody FIA Test98/79 SARS-CoV-2 Ag Test5 refs98/79 SARS-CoV-2 IgG/IgM Test3 refs98/79 2 others SARS-CoV-2 Neutralization Antibody Test98/79 SARS-CoV-2 S-RBD IgG Antibody Test98/79	– 98/79	info@acesolab.com EUDAMED record Report an error
Bitrumed EU representative : VidaQuick Biotech S.L. (Spain)	China	SARS-CoV-2 Ag Test3 refs98/79 SARS-CoV-2 Ag Test (Nasal Swab)98/79 SARS-CoV-2 Ag Test (Oral fluid)2 refs98/79 SARS-CoV-2 IgG Test2 refs98/79 SARS-CoV-2 IgG/IgM Test2 refs98/79 2 others SARS-CoV-2 Neutralization Antibody Test98/79 SARS-CoV-2 S-RBD IgG Antibody Test98/79	– 98/79	info@bitrumed.com.cn EUDAMED record Report an error
Wizbiotech EU representative : QbD RepS BV (Belgium)	China	SARS-CoV-2 Ab Rapid Test (Colloidal Gold)98/79 SARS-CoV-2 Antigen Rapid Test98/79 SARS-CoV-2 Antigen Rapid Test (Colloidal Gold)98/79 SARS-CoV-2 Antigen Rapid Test (Saliva)98/79 SARS-CoV-2 Antigen Rapid Test (Sputum/Saliva/Stool)98/79 2 others SARS-CoV-2 Neutralizing Antibodies Test98/79 Type A, Type B98/79	– 98/79	EUDAMED record Report an error
Aconbio EU representative : MedNet EC-REP GmbH (Germany)	China	ACON SARS-CoV-2 IgG/IgM Rapid Test2 refs98/79 FIAflex SARS-CoV-2 Antigen FIA98/79 Flowflex SARS-CoV-2 Antigen FIA98/79 Flowflex SARS-CoV-2 Antigen Rapid Test4 refs98/79 Flowflex SARS-CoV-2 Antigen Rapid Test (Nasal/Saliva)2 refs98/79 1 other Flowflex SARS-CoV-2 Antigen Rapid Test Slim2 refs98/79	– 98/79	Website EUDAMED record Report an error
Hangzhou Laihe Biotech FDA EU representative : Medunion S.L. (Spain) and 1 other	China	303034-0198/79 303034-0598/79 303034-4098/79 303057; 3030582 refs98/79 303059; 303060; 30306198/79 1 other LYHER ICO-502-01; ICO-502-05; ICO-502-20; ICO-502-25; ICO-502-403 refs	B IVDR, 98/79	office@lyher.com EUDAMED record Report an error
InTec PRODUCTS EU representative : QbD RepS BV (Belgium)	China	69361558COVID19-AG-BE**X5 ITP1601398/79 AQ+ COVID-19 Ag Rapid Test ITP160424 refs98/79 AQ+ COVID-19 Ag Rapid Test ITP1604498/79 AQ+ COVID-19 Ag Rapid Test ITP16044-TC25-98/79 Rapid SARS-CoV-2 Antigen Test ITP160103 refs98/79 1 other Rapid SARS-CoV-2 Antigen Test ITP1601398/79	– 98/79	Website EUDAMED record Report an error
Rapid Labs EU representative : Advena Limited (Malta) and 1 other	United Kingdom (ex Northern Ireland)	COVID-19 Antigen Rapid Test Device-Nasopharyngeal Swab2 refs98/79 COVID-19 IgG/IgM Test Device -Finger Prick WB, WB/S/P2 refs98/79 COVID-19 S-RBD IgG Antibody Test Device -WB/S/P2 refs98/79 SARS-CoV-2 Antigen Rapid Test Device – Swab2 refs98/79 SARS-CoV-2 Neutralization Antibody Rapid Test Devie-WB/S/P98/79	– 98/79	Website info@rapidlabs.co.uk EUDAMED record Report an error
Safecare FDA EU representative : NIC GmbH (Germany) and 1 other	China	COVID-19 Antigen FIA Test (Swab)98/79 COVID-19 Antigen Rapid Test Kit (Swab)98/79 COVID-19 IgG/IgM FIA Test (Serum/Plasma)98/79 COVID-19 IgG/IgM FIA Test (Whole blood/Serum/Plasma)98/79 Kit de Detección Rápida de Antígenos de COVID-19 (Hisopo)-Nasal98/79	– 98/79	EUDAMED record Report an error
Vivachek FDA EU representative : Lotus NL B.V. (Netherlands)	China	Pro SARS-CoV-2 Ag Rapid Test VCD1698/79 Quick MASTER SARS-CoV-2 Ag FIA Test VID442 refs98/79 SARS-CoV-2 Ag Rapid Test VCD0598/79 SARS-CoV-2 IgG Rapid Test VCD24-01-01398/79 SARS-CoV-2 S-RBD IgG Ab Rapid Test VCD25-01-01398/79	– 98/79	info@vivachek.com EUDAMED record Report an error
Xenta Biomedical Science FDA EU representative : CMC Medical Devices & Drugs SL (Spain)	China	COVID-19 Antigen Rapid Detection Kit (Nasal Swab)2 refs98/79 COVID-19 Antigen Rapid Detection Kit (NP Swab)2 refs98/79 COVID-19 Antigen Rapid Detection Kit (Saliva Lollipop)2 refs98/79 COVID-19 Antigen Rapid Detection Kit (Saliva)2 refs98/79 COVID-19 Antigen Rapid Detection Kit (Throat Swab)2 refs98/79	– 98/79	Website EUDAMED record Report an error
Bosonbio FDA EU representative : Lotus NL B.V. (Netherlands) and 1 other	China	Rapid SARS-CoV-2 Antigen Test Card3 refs Rapid SARS-CoV-2 Antigen Test Card 1N40C5-2598/79 SARS-CoV-2 Antigen Test (FIA)98/79 SARS-CoV-2 Neutralizing Antibody Test Card 1N42C298/79	C IVDR, 98/79	Website EUDAMED record Report an error
HangZhou Biotest Biotech FDA EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)	China	Rightsign ICOVN-C8198/79 Rightsign ICOVN-C81H98/79 Rightsign INCP-C8198/79 Rightsign INGM-MC4298/79	– 98/79	info@biotests.com.cn EUDAMED record Report an error
Vitrosens	Türkiye	RapidFor™ SARS-CoV-2 Test Kit2 refs RapidFor™ VSCD02SC98/79 RapidFor™ VSCD02SC0198/79 RapidFor™ VSCD02ST0198/79	B IVDR, 98/79	Website info@vitrosens.com EUDAMED record Report an error
Aaz Productions Le Materiel Biomedical	France	autotest COVID-VIRO ALL IN®5 refs98/79 autotest COVID-VIRO®9 refs98/79 COVID-VIRO98/79	– 98/79	EUDAMED record Report an error
Actest EU representative : VidaQuick Biotech S.L. (Spain)	China	SARS-CoV-2 Antibody rapid test98/79 SARS-CoV-2 Antigen rapid test4 refs98/79 SARS-CoV-2 neutralizing Antibody rapid test98/79	– 98/79	info@actest.com.cn EUDAMED record Report an error
Bioantibody Biotechnology EU representative : Medunion S.L. (Spain)	China	SARS-CoV-2 Antigen Rapid Detection Kit (Latex Chromatography) 1 Tests/Kit98/79 SARS-CoV-2 Antigen Rapid Detection Kit (Latex Chromatography) 25 Tests/Kit98/79 SARS-CoV-2 Antigen Rapid Detection Kit (Latex Chromatography) 5 Tests/Kit98/79	– 98/79	EUDAMED record Report an error
BioChain (Beijing) Science & Technology EU representative : Medunion S.L. (Spain)	China	10 tests/kit98/79 20 tests/kit98/79 5 tests/kit98/79	– 98/79	EUDAMED record Report an error
nal von minden	Germany	NADAL® COVID-19 Ag Test98/79 NADAL® COVID-19 Ag Test CE01979 refs98/79 NADAL® COVID-19 IgG/IgM Test98/79	– 98/79	Website info@nal-vonminden.com EUDAMED record Report an error
Vi̇si̇on Bi̇yoteknoloji̇ Araştirma Geli̇şti̇rme Laboratuvar Si̇stemleri̇ Sanayi̇ Ve Ti̇caret Şi̇rketi̇	Türkiye	COVID 19 HIZLI ANTİJEN TEST KİTİ COVID 19 RAPID ANTIGEN TEST KIT COVID 19 RAPID POC TEST KIT MYCOPLASMA PNEUMONIAE AB HIZLI TEST KİTİ SARS-CoV-2 NEUTRALIZING ANTIBODY RAPID TEST KIT	B IVDR	Website info@visionbiotechnology.com EUDAMED record Report an error
Zhejiang Greylynx Biotech EU representative : Lotus NL B.V. (Netherlands)	China	SARS-CoV-2 Ag Rapid Test GISARSg98/79 SARS-CoV-2 Ag Saliva Rapid Test GISARSg98/79 SARS-CoV-2 IgM/IgG Rapid Test GISARSgm98/79	– 98/79	info@vivachek.com EUDAMED record Report an error
Aichek FDA EU representative : Medunion S.L. (Spain)	China	COVID-19 Antigen Rapid Test98/79 COVID-19 IgG/IgM Rapid Test98/79	– 98/79	ra.rep@aichek.com EUDAMED record Report an error
Assure Tech. (Hangzhou) EU representative : Lotus NL B.V. (Netherlands)	China	COVID 19 Rapid Test98/79 Device COV-S23004H198/79	– 98/79	Website contact@diareagent.com EUDAMED record Report an error
Biobase FDA EU representative : Luxus Lebenswelt GmbH (Germany)	China	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
Biobase Diagnostic Technology (Shandong) EU representative : Luxus Lebenswelt GmbH (Germany)	China	Biobase COVID-19 Antigen Rapid Test 20 Tests/kit98/79 Biobase COVID-19 Antigen Rapid Test 25 Tests/kit98/79	– 98/79	EUDAMED record Report an error
Dezhou Guoke Medical Technology EU representative : MedPath GmbH (Germany)	China	MERS-CoV Antigen Rapid Test Kit98/79 SARS-CoV-2 Ag Detection Kit (Immunofluorescence Chromatography)98/79	– 98/79	office@guoke-medical.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	– 98/79	info@genesignbio.com EUDAMED record Report an error
Gensurebio EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain)	China	COVID-19 Ag Rapid Test P200498/79 COVID-19 IgG+IgM Rapid Test P200298/79	– 98/79	Website info@gensurebio.com EUDAMED record Report an error
HEALSTONE Biotech FDA EU representative : CMC Medical Devices & Drugs SL (Spain)	Canada	Human Parainfluenza Virus Type I / III and Adenovirus Detection Kit (Fluorescence PCR) APA0198/79 One Step Microalbumin Test Cassette (Urine) GIHSA-102a98/79	– 98/79	sales@orientgene.com EUDAMED record Report an error
Medotexbio EU representative : HUMISS TRADING S. L. (Spain) and 1 other	China	Medotex SARS-CoV-2 Antigen Rapid Test 40 Tests98/79 SARS-CoV-2 Antigen Rapid Test	B IVDR, 98/79	Website EUDAMED record Report an error
SD Biosensor FDA EU representative : Medical Technology Promedt Consulting GmbH (Germany)	South Korea	Q-NCOV-07G4 refs STANDARD™ Q COVID-19 Ag Home Test Q-NCOV-03G3 refs	B, C IVDR	Website EUDAMED record Report an error
Shenzhen Lvshiyuan Biotechnology EU representative : CMC Medical Devices & Drugs SL (Spain) and 1 other	China	SARS‐CoV‐2 Antigen Rapid Test Kit SARS‐CoV‐2 Antigen Rapid Test Kit (Colloidal Gold)	B IVDR	Website EUDAMED record Report an error
Türklab Tibbi̇ Mlz. San. Ve Ti̇c. Aş	Türkiye	Covid-19 Ag Test8 refs98/79 SARS-CoV-2 IgM/IgG Ab Test4 refs98/79	– 98/79	Website info@turklab.com.tr EUDAMED record Report an error
Vazyme EU representative : Obelis s.a. (Belgium) and 1 other	China	2019-nCoV IgG/IgM Detection Kit (Colloidal Gold-Based） C6603C98/79 Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Antigen Detection Kit (Colloidal Gold-Based) C8611C98/79	– 98/79	EUDAMED record Report an error
Zhejiang QL Biotech EU representative : CMC Medical Devices & Drugs SL (Spain)	China	QINGLI Device:20 Test/Kit2 refs98/79 QINGLI Strip: 25Tests/Kit2 refs98/79	– 98/79	EUDAMED record Report an error
Acmexbio EU representative : CMC Medical Devices & Drugs SL (Spain)	China	Acmex Cassette98/79	– 98/79	info@acmexbio.com EUDAMED record Report an error
Azubio Diagnostics EU representative : CMC Medical Devices & Drugs SL (Spain)	China	Pen A48410H11	C IVDR	EUDAMED record Report an error
Beijing Applied Biological Technologies EU representative : Luxus Lebenswelt GmbH (Germany)	China	SARS-CoV-2 Antigen Rapid Test Cassette98/79	– 98/79	EUDAMED record Report an error
BioFynder EU representative : SUNGO Europe B.V. (Netherlands)	United Kingdom (ex Northern Ireland)	TruVue COVID-19 Antigen Rapid Test (LFA)98/79	– 98/79	EUDAMED record Report an error
Biosynex EU representative : BIOSYNEX (France)	Switzerland	BIOSYNEX COVID-19 Ag BSS98/79	– 98/79	Website reglementaire@biosynex.com EUDAMED record Report an error
Certest	Spain	CerTest SARS-CoV-23 refs	B IVDR	Website quality@certest.es EUDAMED record Report an error
GC Medical Science EU representative : Medical Technology Promedt Consulting GmbH (Germany)	South Korea	GENEDIA W COVID-19 Ag3 refs98/79	– 98/79	EUDAMED record Report an error
Hightopbio FDA EU representative : MedNet EC-REP GmbH (Germany)	China	SARS-CoV-2 Antigen Rapid Test98/79	– 98/79	Website EUDAMED record Report an error
Labnovation EU representative : MedNet EC-REP GmbH (Germany)	China	SARS-CoV-2 Antigen Rapid Test Kit (Immunochromatography) 20 Tests/Kit98/79	– 98/79	Website info@labnovation.com EUDAMED record Report an error
Limingbio EU representative : Wellkang Ltd (Northern Ireland)	China	StrongStep®SARS-CoV-2 Antigen Rapid Test 25 Tests/box98/79	– 98/79	Website sales@limingbio.com EUDAMED record Report an error
Neo-nostics (Suzhou) Bioengineering EU representative : OSMUNDA Medical Technology Service GmbH (Germany)	China	COVID 19 Antigen Test Kit (Colloidal Gold Method) SVRAG8998/79	– 98/79	EUDAMED record Report an error
Nexlab EU representative : MedNet EC-REP GmbH (Germany)	China	POCBio SARS-CoV-2 Antigen Rapid Test LATR03-C2598/79	– 98/79	EUDAMED record Report an error
Ortho-Clinical Diagnostics Summers Ridge San Diego EU representative : MDSS GmbH (Germany)	United States	Sofia SARS FIA98/79	– 98/79	Website PRRC@quidelortho.com EUDAMED record Report an error
Roche FDA	Germany	cobas lumira SARS-CoV-2 Ag Ultra4 refs	B IVDR	Website EUDAMED record Report an error
Wondfo FDA EU representative : QbD RepS BV (Belgium)	China	2019-nCoV Antigen Test (Lateral Flow Method)3 refs	C IVDR	Website sales@wondfo.com.cn EUDAMED record Report an error
Wuhan Easydiagnosis Biomedicine EU representative : CMC Medical Devices & Drugs SL (Spain) and 1 other No model still on the market	China	100 tests/kit98/79 (no longer marketed) 25 tests/kit98/79 (no longer marketed) 50 tests/kit98/79 (no longer marketed) COVID-19 Ag Test Kit (Immunofluorescence Method) 40 tests/kit98/79 (no longer marketed) COVID-19 Neutralizing Antibody( COVID-19 NAb) Test Kit (Immunofluorescence Method) 20 tests/kit98/79 (no longer marketed) 4 others COVID-19 Neutralizing Antibody( COVID-19 NAb) Test Kit (Immunofluorescence Method) 40 tests/kit98/79 (no longer marketed) Freeze-dried：100 tests/kit98/79 (no longer marketed) Freeze-dried：25 tests/kit98/79 (no longer marketed) Freeze-dried：50 tests/kit98/79 (no longer marketed)	– 98/79	EUDAMED record Report an error
Zhejiang Anji Saianfu Biotechnology EU representative : Lotus NL B.V. (Netherlands) No model still on the market	China	COVID-19 Antigen Rapid Test98/79 (no longer marketed) COVID-19 IgG IgM Rapid Test Kit98/79 (no longer marketed)	– 98/79	EUDAMED record Report an error

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