HomeChinaZYBIO INC.

ZYBIO INC.

China · Chongqing
✓ Record-verifiedregistrations found in 6 markets

This company has registrations in United States, Brazil, South Korea, Hong Kong, 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
2listed device types
Class I 2Class II 0Class III 0
plus 2 registration records and 0 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
117registered devices
Class I 48Class II 69
135 including historic records
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
1GMP quality-system certificates
IVD import 1
AUAustraliaTGA ARTG
pendingnot queried
HKHong KongMDACS
1valid listings
IVD C 1
ILIsraelAMAR
1registrations
RURussiaRoszdravnadzor
45active registrations
Class 1 6Class 2a 37Class 2b 1Class 3 1
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 States2 registration records, 0 510(k), 0 PMA
Brazil117 confirmed, 0 excluded
Manufacturer names merged into this page: ZYBIO INC. · ZYBIO INC

Company information

Country
China
City
Chongqing

Fields marked "pending" have not been obtained yet; that does not mean they do not exist. Risk records (litigation, penalties, operating anomalies) are kept internal and not published.

FDA listed device types

Clinical Sample Concentrator 1Analyzer, Chemistry (Photometric, Discrete), For Clinical Use 1

Registration details (sample)

MarketIdentifierNameClass / date
BR80258020117KIT DE EXTRAÇÃO DE ÁCIDO NUCLÉICOClass I
BR82533950011KIT DE PRÉ-TRATAMENTO DE AMOSTRA MALDI-TOFClass I
BR82533950109Família Sistema de Hemocultura EXBClass II

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