HomeChinaINNOVITA (TANGSHAN) BIOLOGICAL TECHNOLOGY Co., Ltd.

INNOVITA (TANGSHAN) BIOLOGICAL TECHNOLOGY Co., Ltd.

China · Qian'An Hebei
✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Brazil, Russia — 3 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
5listed device types
Class I 1Class II 3Class III 0unclassified 1
plus 5 registration records and 3 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
4registered devices
Class II 4
7 including historic records
SASaudi ArabiaSFDA
0registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
0active device licences
TWTaiwanTFDA
0valid device licences
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
pendingnot queried
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
pendingnot queried
RURussiaRoszdravnadzor
4active registrations
Class 2b 4
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 States5 registration records, 3 510(k), 0 PMA
Brazil4 confirmed, 0 excluded
Manufacturer names merged into this page: INNOVITA (TANGSHAN) BIOLOGICAL TECHNOLOGY Co., Ltd. · INNOVITA (TANGSHAN) BIOLOGICAL TECHNOLOGY CO., LTD. · INNOVITA (TANGSHAN) BIOLOGICAL TECHNOLOGY CO., LTD · INNOVITA (TANGSHAN) BIOLOGICAL TECHNOLOGY CO, LTD.

Company information

Country
China
City
Qian'An Hebei

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

12019 · K192843
12024 · K241919
12025 · K250398

FDA listed device types

Kit, Test, Pregnancy, Hcg, Over The Counter 1Devices Detecting Influenza A, B, And C Virus Antigens 1Visual, Pregnancy Hcg, Prescription Use 1Reagent, Coronavirus Serological 1Test, Luteinizing Hormone (Lh), Over The Counter 1

Registration details (sample)

MarketIdentifierNameClass / date
USK250398Innovita Flu A/B Antigen Rapid Test2025-07-03
USK241919Innovita HCG Pregnancy Rapid Combo Test2024-08-02
USK192843INNOVITA HCG Pregnancy Rapid Test Strip, INNOVITA HCG Pregnancy Rapid Test Cassette, INNOVITA HCG Pregnancy Rapid Test Midstream2019-11-22
BR82948680007Teste de Ovulação FamivitaClass II
BR82948680003Teste de Gravidez FamivitaClass II
BR80002670093TESTE DE OVULAÇÃO FAMIVITAClass II

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