Hysen Biotech. Inc

Korea, Republic · Seoul · www.hysentech.com

✓ Record-verifiedregistrations found in 3 marketsEU SRN KR-MF-000048224

This company has registrations in European Union, United Kingdom, Brazil — 3 overseas markets. The China NMPA lookup is still pending.

Registrations by market

Each market counts a different unit; figures are not directly comparable

CNChinaNMPA

n/aThis registry lists domestic registrants only

EUEuropean UnionEUDAMED

5UDI-DI device records

IVD A 5

USUnited StatesFDA openFDA

0listed device types

Class I 0Class II 0Class III 0

plus 0 registration records and 0 510(k)

UKUnited KingdomMHRA PARD

30registered device records

IVD general 30

BRBrazilANVISA

8registered devices

Class II 8

this export covers Class I / II only (the cadastro route)

SASaudi ArabiaSFDA

0registered imported devices

low-risk imported devices only; a 2023 snapshot, not updated since

CACanadaMDALL

0active device licences

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

pendingnot queried

RURussiaRoszdravnadzor

pendingnot queried

Not yet connected: India CDSCO, Indonesia Kemenkes. The public search for Japan PMDA and Vietnam IMDA does not return manufacturer names, so entries cannot be linked to companies coming — where there is no data it is shown as "pending", never estimated.

How these numbers were verified

record-verified

Company-name search in every official database is a substring match and returns same-named but different companies. Each figure below is the count after re-checking every record against the manufacturer name.

European Union7 raw hits, 2 excluded, 5 confirmed

United States0 registration records, 0 510(k), 0 PMA, 1 excluded

United Kingdom30 confirmed, 0 excluded

Brazil8 confirmed, 0 excluded

Manufacturer names merged into this page: HYSEN BIOTECH.LNC

Regulatory identity

EU manufacturer SRN: KR-MF-000048224
EU authorised representative: Medunion S.L.
UK responsible person: Clinical-Care.co.uk

Registration details (sample)

Market	Identifier	Name	Class / date
EU	08809975891024	—	IVD A
EU	08809975891215	—	IVD A
EU	08809975891208	—	IVD A
EU	08809975891017	—	IVD A
UK	49856	Adenovirus Antigen Test	IVD general
UK	58768	CRP	IVD general
UK	63718	Chikungunya lgG lgM Rapid Test	IVD general
BR	80464810916	Norovirus (GI/GII) Rapid Test Device	Class II
BR	80464810921	Lactoferrin Rapid Test Cassette	Class II
BR	80464810922	Entamoeba Histolytica Rapid Test Cassette	Class II

Hysen Biotech. Inc

Registrations by market

How these numbers were verified

Regulatory identity

Company information

Registration details (sample)

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