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GenSure Biotech Inc.

✓ Record-verifiedregistrations found in 5 marketsEU SRN CN-MF-000028354

This company has registrations in European Union, United Kingdom, Hong Kong, Israel, Russia — 5 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

75UDI-DI device records

IVD B 44IVD C 31

USUnited StatesFDA openFDA

0listed device types

Class I 0Class II 0Class III 0

plus 0 registration records and 0 510(k)

UKUnited KingdomMHRA PARD

6registered device records

IVD general 2Class B – Self-testing or Near-patient Testing 2Class C – Self-testing or Near-patient Testing 2

BRBrazilANVISA

0registered devices

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

1valid listings

IVD C 1

ILIsraelAMAR

27registrations

RURussiaRoszdravnadzor

4active registrations

Class 3 4

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 Union75 raw hits, 0 excluded, 75 confirmed

United Kingdom6 confirmed, 0 excluded

Regulatory identity

EU manufacturer SRN: CN-MF-000028354
EU authorised representative: RIOMAVIX SOCIEDAD LIMITADA
UK responsible person: MedPath Limited

Registration details (sample)

Market	Identifier	Name	Class / date
EU	06976838234914	DIAGOTEC Strep A Rapid Test	IVD C
EU	06976838234907	GenSure Strep A Rapid Test	IVD C
EU	06976838234891	DyonStrepA Strep A Rapid Test	IVD C
EU	16976838235130	EuroGen HCG Pregnancy Rapid Test	IVD B
UK	66563	Strep A Rapid Test	Class C – Self-testing or Near-patient Testing
UK	49119	Flu A+B Ag Rapid Test	Class C – Self-testing or Near-patient Testing
UK	54255	LH Ovulation Rapid Test	Class B – Self-testing or Near-patient Testing

GenSure Biotech Inc.

Registrations by market

How these numbers were verified

Regulatory identity

Company information

Registration details (sample)

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