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SEJOY BIOMEDICAL CO., LTD.

China · Hangzhou City

✓ Record-verifiedregistrations found in 6 markets

This company has registrations in United States, Brazil, Canada, Australia, Israel, Russia — 6 overseas markets. The China NMPA lookup is still pending.

Registrations by market

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

CNChinaNMPA

pendingnot queried

EUEuropean UnionEUDAMED

pendingnot queried

USUnited StatesFDA openFDA

5listed device types

Class I 3Class II 2Class III 0

plus 5 registration records and 1 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

13registered devices

Class II 13

19 including historic records

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

4active device licences

Class II 4

13 including historic records

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

4active ARTG entries

IVD Class 1 1IVD Class 2 1IVD Class 3 2

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

1registrations

RURussiaRoszdravnadzor

2active registrations

Class 2b 2

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.

United States5 registration records, 1 510(k), 0 PMA, 2 excluded

Brazil13 confirmed, 1 excluded

Canada4 confirmed, 0 excluded

Manufacturer names merged into this page: SEJOY BIOMEDICAL CO., LTD.

FDA 510(k) clearances by year

12024 · K240640

FDA listed device types

Test, Follicle Stimulating Hormone (Fsh), Over The Counter 1Single (Specified) Analyte Controls (Assayed And Unassayed) 1Test, Luteinizing Hormone (Lh), Over The Counter 1Kit, Test, Pregnancy, Hcg, Over The Counter 1System, Test, Blood Glucose, Over The Counter 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K240640	Sejoy Blood Glucose Monitoring System; Sejoy Advance Link Blood Glucose Monitoring System	2024-10-08
BR	82195300015	Teste de Menopausa FSH em uma etapa	Class II
BR	82195300021	Teste de Gravidez HCG em uma etapa	Class II
BR	82195300022	Teste de Ovulação LH em uma etapa	Class II
CA	81398	DIGITAL THERMOMETERS	Class II
CA	81399	WRIST-TYPE FULLY AUTOMATIC BLOOD PRESSURE MONITORS	Class II
CA	81400	ARM-TYPE FULLY AUTOMATIC BLOOD PRESSURE MONITORS	Class II

SEJOY BIOMEDICAL CO., LTD.

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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