Infectious diseasesInfectious immunology - rapid tests & point of careHepatitis viruses - RT & POC

Hbsag - RT & POC

EMDN code W0105090201

11 manufacturers, 31 models including 31 on the market, 6 countries

On the market in Manufacturer country

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	HBsAg Test Eco TIHB0498/79 HBsAg Test IHB0398/79 HBsAg Test IHB0498/79 HBsAg Test Plus TIHB0414098/79 HBsAg Test Pro TIHB0434098/79 7 others HBsAg Test RTHB0398/79 HBsAg Test RTHB0498/79 HBsAg Test Single TIHB0420598/79 HBsAg Test Single TIHB0422098/79 HBsAg Test THB0398/79 HBsAg Test THB0498/79 HBsAg Test TIHB0398/79	– 98/79	Website info@turklab.com.tr EUDAMED record Report an error
Wuhan Life Origin Biotech Joint Stock EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain)	China	Hepatitis B Virus Surface Antigen Assay Kit (Fluorescence Immunochromatographic Assay) 10 tests/kit98/79 Hepatitis B Virus Surface Antigen Assay Kit (Fluorescence Immunochromatographic Assay) 100 tests/kit98/79 Hepatitis B Virus Surface Antigen Assay Kit (Fluorescence Immunochromatographic Assay) 20 tests/kit98/79 Hepatitis B Virus Surface Antigen Assay Kit (Fluorescence Immunochromatographic Assay) 25 tests/kit98/79 Hepatitis B Virus Surface Antigen Assay Kit (Fluorescence Immunochromatographic Assay) 50 tests/kit98/79	– 98/79	EUDAMED record Report an error
Hangzhou Alltest Biotech EU representative : MedNet EC-REP GmbH (Germany)	China	HBsAg Rapid Test Cassette (Whole Blood/Serum/Plasma) IHBSG-40298/79 HBsAg Rapid Test Cassette IHBSG-40298/79 Prueba Rápida de HBsAg en Casete98/79	– 98/79	info@alltests.com.cn EUDAMED record Report an error
Artronlab EU representative : MedNet EC-REP GmbH (Germany)	Canada	Acmex Hepatitis B Surface Antigen (HBsAg) Test Cassette2 refs Artron Hepatitis B Virus Surface Antigen (HBsAg) Test Cassette98/79	D IVDR, 98/79	Website info@artronlab.com EUDAMED record Report an error
Mpbio EU representative : MP Biomedicals Germany GmbH (Germany)	Singapore	MP Diagnostics HBsAg ELISA 4.1 23470-096 (96 wells)98/79 MP Diagnostics HBsAg ELISA 4.1 23470-480 (480 wells)98/79	– 98/79	EUDAMED record Report an error
Rapid Labs EU representative : Advena Limited (Malta)	United Kingdom (ex Northern Ireland)	HAV IgM Rapid Test Device – WB/S/P98/79 HAV IgM Rapid Test S/P D-HAVMD2098/79	– 98/79	Website info@rapidlabs.co.uk EUDAMED record Report an error
Abon Biopharm(Hangzhou) EU representative : Medical Technology Promedt Consulting GmbH (Germany)	China	IHBsg-40298/79	– 98/79	EUDAMED record Report an error
Cupidlimited EU representative : Amstermed B.V. (Netherlands)	India	CupiKIT	D IVDR	Website qa@cupidlimited.com EUDAMED record Report an error
HangZhou Biotest Biotech EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)	China	RightSign IHBSG-C3198/79	– 98/79	info@biotests.com.cn EUDAMED record Report an error
Koroglu Medikal Tibbi Malzemeleri Kozmetik Ithalat Ihracat Sanayi Ve Ticaret Sti	Türkiye	LABOQUICK98/79	– 98/79	Website info@koroglugroup.com EUDAMED record Report an error
Premier Medical EU representative : Obelis s.a. (Belgium)	India	First Response HBsAg Card Test PI10FRC4 refs98/79	– 98/79	Website info@premiermedcorp.com EUDAMED record Report an error

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