HomeSpainCERTEST BIOTEC

CERTEST BIOTEC

Spain
✓ Record-verifiedregistrations found in 2 markets

This company has registrations in Brazil, Canada — 2 overseas markets. The China NMPA lookup is still pending.

Registrations by market

Each market counts a different unit; figures are not directly comparable
CNChinaNMPA
n/aThis registry lists domestic registrants only
EUEuropean UnionEUDAMED
pendingnot queried
USUnited StatesFDA openFDA
0listed device types
Class I 0Class II 0Class III 0
plus 0 registration records and 0 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
32registered devices
Class I 10Class II 22
109 including historic records
SASaudi ArabiaSFDA
0registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
0active device licences
10 including historic records
TWTaiwanTFDA
pendingnot queried
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
pendingnot queried
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
pendingnot queried
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.

Brazil32 confirmed, 0 excluded
Manufacturer names merged into this page: CERTEST BIOTEC S.L. · CERTEST BIOTEC, S.L. · CERTEST BIOTEC
Same-named companies — This database also contains companies with near-identical names: CERTEST BIOTEC, S.L.. Company name alone cannot separate their registrations, so the figures below may include either.

Company information

Country
Spain

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.

Registration details (sample)

MarketIdentifierNameClass / date
BR10355870423Kit de Detecção por PCR em Tempo Real VIASURE RotavírusClass II
BR82149920166VIASURE BK virus q Real Time PCR Detection KitClass II
BR82149920167VIASURE BK virus q Real Time PCR Detection Kit (Tube)Class II

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