Manufacturer

Hysenbiotech

South KoreaLegal entities : Hysen Biotech.Inc

Markets : Italy · Spain

Approvals : EU – class A

EU representative : Medunion S.L. (Spain)

22 categories, 32 models including 32 on the market, 1 country

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

Category	EMDN code	Registered models	Class	Contact
Blood stream infection/sepsis (bacteria & fungi) - multiplex NA reagents	W0105070202	Blood Pathogens and Drug Resistance Genes Digital PCR Detection Kit Plus98/79 Drug Resistance Genes Digital PCR Detection Kit98/79 Multiplex Infection Pathogens & Resistance Genes Detection Kit DMIR0198/79	– 98/79	EUDAMED record Report an error
STIS / STDS (c.trachomatis, n.gonorrhoeae ,m.genitalium, t.vaginalis, ureaplasma spp….) combination - multiplex NA reagents	W0105070501	Sexually Transmitted Disease (STD) Pathogen Multiplex Detection Kit98/79 Sexually Transmitted Disease (STD) Pathogens Multiplex Detection Kit98/79 Sexually Transmitted Disease (STD) Pathogens Multiplex Detection Kit II98/79	– 98/79	EUDAMED record Report an error
Dengue - RT & POC	W0105099007	Dengue IgG/IgM Rapid Test Cassette HIDC-402A98/79 Dengue NS1 Rapid Test Cassette98/79	– 98/79	EUDAMED record Report an error
Gastrointestinal infections - multiplex NA reagents	W0105070504	Gastrointestinal Pathogens Multiplex Detection Kit MAA-17E98/79 Gastrointestinal Pathogens Nucleic acid Detection Kit (Microfluic Chip)98/79	– 98/79	EUDAMED record Report an error
H. pylori - RT & POC	W0105090102	H. pylori Antibody Rapid Test Cassette/Strip HIHP-402/HIHP-40198/79 H. pylori Antigen Rapid Test Cassette HIHPG-60298/79	– 98/79	EUDAMED record Report an error
Nucleic acid testing instruments except micro-arrays - consumables	W02050185	Digital PCR Universal Kit Microfluidic chip	A IVDR	EUDAMED record Report an error
Respiratory tract infections - multiplex NA reagents	W0105070503	Lower Respiratory Pathogens Multiplex Detection Kit MLR-19E98/79 Respiratory Pathogens Multiplex Detection Kit MUR-24E98/79	– 98/79	EUDAMED record Report an error
Tropical fever - multiplex NA reagents	W0105070506	Arbovirus Multiplex Detection Kit98/79 Tropical Pathogens Multiplex Detection Kit MAA-1898/79	– 98/79	EUDAMED record Report an error
Adenovirus	W0105040601	Adenovirus Rapid Test Cassette HIAD-60298/79	– 98/79	EUDAMED record Report an error
Gram+ - gram- - fungi - multiplex NA reagents	W0105070201	Fungal Digital PCR Detection Kit98/79	– 98/79	EUDAMED record Report an error
Influenza a and /or b - RT & POC	W0105099004	Influenza A+B Rapid Test Cassette HIFL-52298/79	– 98/79	EUDAMED record Report an error
Meningitis / encephalitis infections - multiplex NA reagents	W0105070505	Meningitis/Encephalitis (ME) Pathogens Multiplex Detection Kit98/79	– 98/79	EUDAMED record Report an error
Nucleic acid testing apparatuses - rapid and point of care tests	W02050301	HysenDx 200	A IVDR	EUDAMED record Report an error
Nucleic acid testing integrated extraction /amplification /detection systems	W02050116	HysenD30H	A IVDR	EUDAMED record Report an error
Other multiple infectious - multiplex NA reagents	W0105070502	Blood Pathogens and Drug Resistance Genes Digital PCR Detection Kit98/79	– 98/79	EUDAMED record Report an error
Other virus combinations - multiplex NA reagents	W0105070302	Human Herpesvirus Digital PCR Detection Kit98/79	– 98/79	EUDAMED record Report an error
Plasmodium (malaria) - RT & POC	W0105090401	Malaria P.f./Pan Rapid Test Cassette HIMPN-40298/79	– 98/79	EUDAMED record Report an error
Reagents for DNA and/or RNA extraction and preparation: bacteria and/or virus	W0105900101	cfNDA-P1	A IVDR	EUDAMED record Report an error
Rotavirus	W0105040606	Rotavirus Rapid Test Cassette HIRO-60298/79	– 98/79	EUDAMED record Report an error
Strep. a - RT & POC	W0105090103	Strep A Rapid Test Cassette/Strip HISTA-502/HISTA-50198/79	– 98/79	EUDAMED record Report an error
Syphilis - RT & POC	W0105090105	Syphilis Rapid Test Cassette/Strip HISY-402/HISY-40198/79	– 98/79	EUDAMED record Report an error
Various sample processing instruments - other	W02069099	Auto-Pure 10B	A IVDR	EUDAMED record Report an error

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