HomeChinaABON BIOPHARM (HANGZHOU) CO., LTD.

ABON BIOPHARM (HANGZHOU) CO., LTD.

China · Hangzhou
✓ Record-verifiedregistrations found in 9 markets

This company has registrations in United States, Brazil, Canada, Taiwan, Singapore, South Korea, Australia, Hong Kong, Russia — 9 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
17listed device types
Class I 3Class II 13Class III 0unclassified 1
plus 30 registration records and 0 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
22registered devices
Class II 22
32 including historic records
SASaudi ArabiaSFDA
0registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
0active device licences
1 including historic records
TWTaiwanTFDA
4valid device licences
Class I 3Class II 1
SGSingaporeHSA SMDR
6device registrations
CLASS B 5CLASS C 1
KRSouth KoreaMFDS GMP
2GMP quality-system certificates
IVD import 2
AUAustraliaTGA ARTG
7active ARTG entries
IVD Class 1 3IVD Class 2 4
HKHong KongMDACS
6valid listings
IVD C 1IVD D 5
ILIsraelAMAR
pendingnot queried
RURussiaRoszdravnadzor
14active registrations
Class 1 2Class 2a 1Class 2b 6Class 3 5
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 States30 registration records, 0 510(k), 0 PMA
Brazil22 confirmed, 0 excluded
Manufacturer names merged into this page: ABON BIOPHARM (HANGZHOU) CO., LTD. · ABON BIOPHARM (HANGZHOU) CO LTD · ABON BIOPHARM CO. LTD · ABON BIOPHARM CO, LTD. · ABON BIOPHARM (HANGZHOU) CO., LTD
Same-named companies — This database also contains companies with near-identical names: ABON BIOPHARM CO., LTD.. Company name alone cannot separate their registrations, so the figures below may include either.

Company information

Country
China
City
Hangzhou

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

showing 8 of 17
Visual, Pregnancy Hcg, Prescription Use 1Enzyme Immunoassay, Opiates 1Test, Opiates, Over The Counter 1Enzyme Immunoassay, Benzodiazepine 1Enzyme Immunoassay, Amphetamine 1Enzyme Immunoassay, Methadone 1Enzyme Immunoassay, Cannabinoids 1Gas Chromatography, Methamphetamine 1

Registration details (sample)

MarketIdentifierNameClass / date
BR10071779015Lancetas de segurança Tianjin ABONClass II
BR10071770878MET One Step Methamphetamine TestClass II
BR10071770936Clearview One Step H. pylori Antigen TestClass II

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