Hysen Biotech.Inc

Active in EUDAMED

South Koreafrom SRN EUDAMED SRN KR-MF-000048224

Devices: 47
Registrations: EUDAMED

At a glance

Counted by deviCERTS from registry records

Market reach

European Union: EUDAMED actor

Catalogue47

Newest first, rows 1-47 of 47

Search and filter all 47 devices

Rows 1-47 of 47

Company details

EUDAMED SRN: KR-MF-000048224
EUDAMED status: Active
EUDAMED registered name: Hysen Biotech.Inc
Registered address: 401, Yangcheon-ro, 07528, Seoul, South Korea
Email: [email protected]
PRRC contact: Cindy Heng(public in EUDAMED)

Frequently asked questions

How many devices does Hysen Biotech.Inc have in the registry?

The registry currently lists 47 devices for Hysen Biotech.Inc. Devices recorded under merged duplicate company entries are counted once.

Which registries list Hysen Biotech.Inc's devices?

Among its 47 most recently registered devices, Hysen Biotech.Inc has devices listed in EUDAMED (47 devices).

What risk classes do Hysen Biotech.Inc's devices fall under?

Among its 47 most recently registered devices, the classes recorded for Hysen Biotech.Inc's devices are IVDR Class A and IVD general. Each device page shows its own class and authorisation.

What are the newest devices from Hysen Biotech.Inc in the registry?

The most recently registered devices listed for Hysen Biotech.Inc include Nucleic Acid Purification System, FOB Rapid Test Cassette/Strip, Vitamin D Rapid Test Cassette and Strep A Rapid Test Cassette/Strip.

Generated automatically from registry data and not verified by a human reviewer.

At a glance

Market reach

Catalogue47

Nucleic Acid Purification System Ref Auto-Pure 10B

FOB Rapid Test Cassette/Strip Ref HTFO-602/HTFO-601

Vitamin D Rapid Test Cassette Ref HSVD-402

Strep A Rapid Test Cassette/Strip Ref HISTA-502/HISTA-501

Urinalysis Reagent Strips (Urine) Ref HURS-1X1 (X:1~11)

H. pylori Antigen Rapid Test Cassette Ref HIHPG-602

HysenD30H

Adenovirus Rapid Test Cassette Ref HIAD-602

Calprotectin semi-quantitative Rapid Test Cassette Ref HCAL-602Q

Gastrointestinal Pathogens Multiplex Detection Kit Ref MAA-17E

Gastrointestinal Pathogens Nucleic acid Detection Kit (Microfluic Chip) Ref MGI-26E

Amyloid β Protein (Aβ) Rapid Test Cassette Ref HAM-102

Blood Pathogens and Drug Resistance Genes Digital PCR Detection Kit Ref DBP01

Vitamin B12 Test Kit Ref HVB-402

Digital PCR Universal Kit Ref DUK01

HysenDx 200

Influenza A+B Rapid Test Cassette Ref HIFL-522

Troponin I Rapid Test Cassette Ref HCTI-402A

Nucleic Acid Extraction or Purification Reagent Ref DNE01

Breast Cancer–associated Gene Mutation Digital PCR Detection Kit Ref DBC01

Dengue NS1 Rapid Test Cassette Ref HIDN-402A

Human Herpesvirus Digital PCR Detection Kit Ref DHV01

Rotavirus Rapid Test Cassette Ref HIRO-602

Sexually Transmitted Disease (STD) Pathogens Multiplex Detection Kit II Ref MAA-16E

Multiplex Infection Pathogens & Resistance Genes Detection Kit Ref DMIR01

Meningitis/Encephalitis (ME) Pathogens Multiplex Detection Kit Ref MME-14E

hCG One Step Pregnancy Test Device (Urine/Serum) Ref HFHC-202

Malaria P.f./Pan Rapid Test Cassette Ref HIMPN-402

Dengue IgG/IgM Rapid Test Cassette Ref HIDC-402A

Lung Cancer Digital PCR Detection Kit Plus Ref DLC02

Arbovirus Multiplex Detection Kit Ref MAV-10

BCR-ABL p190/p210/p230 Digital PCR Detection Kit Ref DBA03

EGFR Mutations Digital PCR Detection Kit Ref DEG02

Drug Resistance Genes Digital PCR Detection Kit Ref DDR01

Vitamin D FIA Test Kit Ref HSVD-F402

G6PD Test Kit Ref HG6PD-402

Fungal Digital PCR Detection Kit Ref DFG01

Syphilis Rapid Test Cassette/Strip Ref HISY-402/HISY-401

H. pylori Antibody Rapid Test Cassette/Strip Ref HIHP-402/HIHP-401

TERT/BRAF Mutations Digital PCR Detection Kit Ref DTE01

Multi-Drug Rapid Test Panel Ref HDOA-1X4 (X:1~12)

Spinal Muscular Atrophy (SMA) Digital PCR Detection Kit Ref DSM01

Blood Pathogens and Drug Resistance Genes Digital PCR Detection Kit Plus Ref DBP02

Sexually Transmitted Disease (STD) Pathogens Multiplex Detection Kit Ref MST-14E

Microfluidic chip Ref DMC01

Lower Respiratory Pathogens Multiplex Detection Kit Ref MLR-19E

Respiratory Pathogens Multiplex Detection Kit Ref MUR-24E

Company details

Frequently asked questions