Infectious diseasesOther virology tests (infect. immunology/NAT)Other virology antigen/antibody detection

Rotavirus

EMDN code W0105040606

46 manufacturers, 69 models including 65 on the market, 11 countries

On the market in Models on the market only Manufacturer country

Manufacturers registered in Europe (EUDAMED) 46

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
Türklab Tibbi̇ Mlz. San. Ve Ti̇c. Aş	Türkiye	Rotavirus Test IROV0198/79 Rotavirus Test RTROV0198/79 Rotavirus Test TIROV0198/79 Rotavirus Test TIROV0100198/79 Rotavirus Test TIROV0101098/79 1 other Rotavirus Test TROV0198/79	– 98/79	Website info@turklab.com.tr EUDAMED record Report an error
Keyubio EU representative : CMC Medical Devices & Drugs SL (Spain) and 1 other	China	KEYU Rotavirus (RV) Group A Antigen Test Kit (Colloidal gold method) ARV-I98/79 KEYU Rotavirus (RV) Group A Antigen Test Kit (Colloidal gold method) ARV-II98/79 KEYU Rotavirus (RV) Group A Antigen Test Kit (Colloidal gold method) ARV-III98/79 KEYU Rotavirus Group A Antigen Rapid Test (Colloidal Gold) RV-R-F98/79 KEYU Rotavirus Group A Antigen Rapid Test (Colloidal Gold) RV-R-G98/79	– 98/79	Website export@keyubio.com EUDAMED record Report an error
Abbott FDA EU representative : Medical Technology Promedt Consulting GmbH (Germany)	South Korea	Bioline™ Rotavirus98/79 Bioline™ Rotavirus 14FK1098/79 SD BIOLINE Rotavirus 14FK1098/79	– 98/79	Website EUDAMED record Report an error
Koroglu Medikal Tibbi Malzemeleri Kozmetik Ithalat Ihracat Sanayi Ve Ticaret Sti	Türkiye	CERTAIN98/79 LABOQUICK98/79 SURELAB98/79	– 98/79	Website info@koroglugroup.com EUDAMED record Report an error
Acro Biotech FDA EU representative : MedNet EC-REP GmbH (Germany) and 1 other	United States	Rotavirus Rapid Test Cassette (Feces) IRO-60298/79 Rotavirus Rapid Test Cassette ROT2F98/79	– 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	Rotavirus Antigen Rapid Test A49930125, A49930225 Rotavirus FIA ROTA-F23F398/79	B IVDR, 98/79	Website contact@diareagent.com EUDAMED record Report an error
Hangzhou Alltest Biotech FDA EU representative : MedNet EC-REP GmbH (Germany) and 1 other	China	Rotavirus Rapid Test Cassette IRO-60298/79 Rotavirus Rapid Test Cassette IRO-R60298/79	– 98/79	info@alltests.com.cn EUDAMED record Report an error
Healgen FDA EU representative : CMC Medical Devices & Drugs SL (Spain)	United States	Rotavirus Rapid Test Cassette (Feces) GCROA-602a98/79 Rotavirus Rapid Test Cassette (Feces) GCROA-602Ca98/79	– 98/79	quality@healgen.com EUDAMED record Report an error
R-Biopharm FDA	Germany	RIDASCREEN® Rotavirus3 refs RIDA®QUICK Rotavirus98/79	B IVDR, 98/79	Website EUDAMED record Report an error
Shenzhen Huian Biosci Technology EU representative : SUNGO Europe B.V. (Netherlands)	China	1T/Kit98/79 20T/Kit98/79	– 98/79	info@huiantech.com EUDAMED record Report an error
Vitrosens	Türkiye	RapidFor™ Rotavirus Rapid Test Kit (FIA) VMPO642 refs98/79 RapidFor™ VMPO64GD98/79	– 98/79	Website info@vitrosens.com EUDAMED record Report an error
Zhejiang QL Biotech EU representative : CMC Medical Devices & Drugs SL (Spain)	China	QINGLI IRO-60298/79 QINGLI Strip(IRO-601)98/79	– 98/79	EUDAMED record Report an error
Aconbio EU representative : MedNet EC-REP GmbH (Germany)	China	Flowflex98/79	– 98/79	Website EUDAMED record Report an error
Anhui Deepblue Medical Technology FDA EU representative : Medunion S.L. (Spain)	China	Rotavirus Antigen Test Kit(Colloidal Gold) Cassette2 refs98/79	– 98/79	sales@dbluemedical.com EUDAMED record Report an error
Anhui Formaster Biosci EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain)	China	Rotavirus Rapid Test (Feces) IRO-301398/79	– 98/79	Website EUDAMED record Report an error
Arcdia	Finland	mariPOC® Rotavirus test reagent98/79	– 98/79	Website office@arcdia.com EUDAMED record Report an error
Atlas Medical FDA	Germany	Atlas Rotavirus Antigen Test Cassette, Stool Sample, Individually Pouched, 20 Tests/Box (Buffer to be supplied in Extraction Tubes) 8.04.69.0.002098/79	– 98/79	Website info@atlas-medical.com EUDAMED record Report an error
AVE Science & Technology FDA EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)	China	1piece/box, 5 pieces/box, 25 pieces /box, 50 pieces /box, 100 pieces /box.98/79	– 98/79	EUDAMED record Report an error
Beijing Jinwofu Bioengineering Technology EU representative : CMC Medical Devices & Drugs SL (Spain)	China	JWF98/79	– 98/79	EUDAMED record Report an error
Beijing Wantai Biological Pharmacy Enterprise EU representative : QbD RepS BV (Belgium)	China	Rotavirus Group A Diagnostic Kit (Colloidal Gold Device)2 refs98/79	– 98/79	EUDAMED record Report an error
BioFynder EU representative : SUNGO Europe B.V. (Netherlands)	United Kingdom (ex Northern Ireland)	TruVue98/79	– 98/79	EUDAMED record Report an error
Boditech FDA EU representative : Obelis s.a. (Belgium)	South Korea	AFIAS ROTA98/79	– 98/79	Website marketing@boditech.co.kr EUDAMED record Report an error
Campmedica	Romania	See Now98/79	– 98/79	Website EUDAMED record Report an error
Certest	Spain	CerTest CLIA Rotavirus Ag2 refs	B IVDR	Website quality@certest.es EUDAMED record Report an error
Clonit	Italy	Rotavirus Card CLZC19402298/79	– 98/79	Website info@clonit.it EUDAMED record Report an error
Cybereagen EU representative : CMC Medical Devices & Drugs SL (Spain)	China	Rotavirus Rapid Test Device (feces) A440401D98/79	– 98/79	info@cybereagen.com EUDAMED record Report an error
DiaSorin FDA EU representative : DiaSorin Italia S.p.A. (Italy)	United States	LIAISON® Rotavirus98/79	– 98/79	Website ivdr_dsu@diasorin.com EUDAMED record Report an error
Encode EU representative : CMC Medical Devices & Drugs SL (Spain)	China	Rotavirus Group A Antigen Rapid Test W010504060698/79	– 98/79	Website EUDAMED record Report an error
Fanttest EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain)	China	25 tests/kit98/79	– 98/79	info@fanttest.com EUDAMED record Report an error
Genesignbio EU representative : SUNGO Europe B.V. (Netherlands)	China	1 test/kit98/79	– 98/79	info@genesignbio.com EUDAMED record Report an error
Gensurebio EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain)	China	Rotavirus Ag Rapid Test P202298/79	– 98/79	Website info@gensurebio.com EUDAMED record Report an error
HangZhou Biotest Biotech FDA EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)	China	Rightsign IROT-C6198/79	– 98/79	info@biotests.com.cn EUDAMED record Report an error
Hangzhou Immuno Biotech EU representative : CMC Medical Devices & Drugs SL (Spain)	China	Rotavirus Antigen Rapid Test HROTA027G98/79	– 98/79	info@jgbiotech.com EUDAMED record Report an error
Hysenbiotech EU representative : Medunion S.L. (Spain)	South Korea	Rotavirus Rapid Test Cassette HIRO-60298/79	– 98/79	EUDAMED record Report an error
InTec PRODUCTS EU representative : QbD RepS BV (Belgium)	China	Rapid Rotavirus Test ITP1400198/79	– 98/79	Website EUDAMED record Report an error
Kangmei Tianhong Biotech (Beijing) EU representative : Lotus NL B.V. (Netherlands)	China	Diagnostic Kit for Group A Rotavirus (Colloidal Gold) 10 Tests/box98/79	– 98/79	Website info@kindmay.com EUDAMED record Report an error
Medotexbio EU representative : Llins Service & Consulting GmbH (Germany)	China	Rotavirus Rapid Test ROTA-602a98/79	– 98/79	Website EUDAMED record Report an error
Neomedica EU representative : Wellkang Ltd (Northern Ireland)	Serbia	Rotavirus C1809V24ROTV98/79	– 98/79	Website EUDAMED record Report an error
Orientgene FDA EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)	China	Rotavirus Rapid Test Cassette (Feces) GCROA-602a98/79	– 98/79	EUDAMED record Report an error
Oxoid FDA EU representative : Thermo Fisher Diagnostics B.V. (Netherlands)	United Kingdom (ex Northern Ireland)	ProSpecT Rotavirus Microplate Assay98/79	– 98/79	Website EUDAMED record Report an error
Seramun	Germany	Serazym® Rotavirus98/79	– 98/79	info@seramun.com EUDAMED record Report an error
Vivachek FDA EU representative : Lotus NL B.V. (Netherlands)	China	Rotavirus Test Kit (FIA) VID12398/79	– 98/79	info@vivachek.com EUDAMED record Report an error
Wizbiotech EU representative : QbD RepS BV (Belgium)	China	Diagnostic Kit for Antigen to Rotavirus (Latex)98/79	– 98/79	EUDAMED record Report an error
Wondfo FDA EU representative : QbD RepS BV (Belgium)	China	Diagnostic Kit for Rotavirus Antigen (Colloidal Gold)2 refs98/79	– 98/79	Website sales@wondfo.com.cn EUDAMED record Report an error
Wuhan Easydiagnosis Biomedicine EU representative : CMC Medical Devices & Drugs SL (Spain) No model still on the market	China	20 tests/kit98/79 (no longer marketed) Rota/Adeno Combo Test Kit (Immunofluorescence Method) 20 tests/kit98/79 (no longer marketed) Rotavirus (ROTA) Test Kit (Immunofluorescence Method) 40 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	Rotavirus Rapid Test98/79 (no longer marketed)	– 98/79	EUDAMED record Report an error

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