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GENOBIO PHARMACEUTICAL CO., LTD.

China · Tianjin

✓ Record-verifiedregistrations found in 6 markets

This company has registrations in United States, Brazil, Canada, South Korea, Hong Kong, Israel — 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

1listed device types

Class I 0Class II 1Class III 0

plus 1 registration records and 0 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

9registered devices

Class II 9

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

8 including historic records

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

1GMP quality-system certificates

IVD import 1

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

1valid listings

IVD C 1

ILIsraelAMAR

1registrations

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.

United States1 registration records, 0 510(k), 0 PMA

Brazil9 confirmed, 0 excluded

Manufacturer names merged into this page: GENOBIO PHARMACEUTICAL CO., LTD. · GENOBIO PHARMACEUTICAL CO., LTD · GENOBIO PHARMACEUTICAL

Registration details (sample)

Market	Identifier	Name	Class / date
BR	80461910002	Kit de Detecção FungiXpert de Anticorpos IgG Aspergillus (Lateral Flow	Class II
BR	80461910003	Kit de Detecção FungiXpert Aspergillus Galactomannan (Lateral Flow Ass	Class II
BR	80461910005	Kit de Detecção ELISA FungiXpert Aspergillus Galactomannan	Class II

GENOBIO PHARMACEUTICAL CO., LTD.

Registrations by market

How these numbers were verified

Company information

FDA listed device types

Registration details (sample)

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