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Home›China›Biobase Scientific (Shandong) Co., Ltd.

Biobase Scientific (Shandong) Co., Ltd.

China · Jinan
✓ Record-verifiedregistrations found in 2 markets

This company has registrations in United States, Brazil — 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
pendingnot queried
EUEuropean UnionEUDAMED
pendingnot queried
USUnited StatesFDA openFDA
70listed device types
Class I 56Class II 14Class III 0
plus 70 registration records and 1 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
31registered devices
Class I 6Class II 25
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
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.

United States70 registration records, 1 510(k), 0 PMA, 1 excluded
Brazil31 confirmed, 3 excluded
Manufacturer names merged into this page: BIOBASE BIODUSTRY(SHANDONG)CO., LTD · BIOBASE BIODUSTRY (SHANDONG) CO., LTD · BIOBASE BIODUSTRY (SHANDONG) CO., LTD. · BIOBASE SCIENTIFIC (SHANDONG) CO., LTD
Same-named companies — This database also contains companies with near-identical names: Biobase Biodustry (Shandong)Co.,Ltd. Company name alone cannot separate their registrations, so the figures below may include either.

Company information

Country
China
City
Jinan

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 510(k) clearances by year

12021 · K210815

FDA listed device types

showing 8 of 70
Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine 1Biuret (Colorimetric), Total Protein 1Lowry (Colorimetric), Total Protein 1Factor B, Antigen, Antiserum, Control 1System, Test, Beta-2-Microglobulin Immunological 1Differential Rate Kinetic Method, Lactate Dehydrogenase Isoenzymes 1Real Time Nucleic Acid Amplification System 1Radioassay, Angiotensin Converting Enzyme 1

Registration details (sample)

MarketIdentifierNameClass / date
USK210815Disposable Face Mask2021-05-13
BR80805750003Família Analisador HematológicoClass II
BR80805750002Analisador HematológicoClass II
BR82832860049ANALISADOR AUTOMÁTICO DE HEMATOLOGIA BK-3200Class II

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