Home›China›Bioteke Corporation (Wuxi) Co., Ltd.

Bioteke Corporation (Wuxi) Co., Ltd.

China · Wuxi City Jiangsu

✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Australia, Hong Kong — 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

21listed device types

Class I 17Class II 3Class III 0unclassified 1

plus 21 registration records and 1 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

0registered devices

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

4active ARTG entries

IVD Class 1 3IVD Class 2 1

HKHong KongMDACS

1valid listings

IVD C 1

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 States21 registration records, 1 510(k), 0 PMA, 1 excluded

Manufacturer names merged into this page: BIOTEKE CORPORATION (WUXI) CO., LTD

FDA 510(k) clearances by year

12022 · K211707

FDA listed device types

showing 8 of 21

Container, Specimen, Sterile 1Analyzer, Chemistry (Sequential Multiple, Continuous Flow) Clinical Use 1Container, Specimen Mailer And Storage, Sterile 1Immunoassay, Insulin-Like Growth Factor Binding Protein-1 1Test, Follicle Stimulating Hormone (Fsh), Over The Counter 1Clinical Sample Concentrator 1Culture Media, Single Biochemical Test 1Container, Specimen, Non-Sterile 1

Bioteke Corporation (Wuxi) Co., Ltd.

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

Similar companies