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SHENZHEN DAKEWE BIO-ENGINEERING CO., LTD.

China · Shenzhen Guangdong

✓ Record-verifiedregistrations found in 4 markets

This company has registrations in United States, Brazil, Israel, Russia — 4 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

7listed device types

Class I 7Class II 0Class III 0

plus 7 registration records and 3 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

8registered devices

Class I 8

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

1registrations

RURussiaRoszdravnadzor

2active registrations

Class 2a 2

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 States7 registration records, 3 510(k), 0 PMA, 1 excluded

Brazil8 confirmed, 1 excluded

Manufacturer names merged into this page: SHENZHEN DAKEWE BIO-ENGINEERING CO., LTD.

FDA 510(k) clearances by year

22023 · K230035

12024 · K240235

FDA listed device types

Clinical Sample Concentrator 1Immunohistochemistry Reagents And Kits 1General Purpose Reagent 1Hematoxylin 1Eosin Y 1Mounting Media 1Culture Media, Non-Selective And Non-Differential 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K240235	OmniTrans Transport System	2024-08-19
US	K230035	BioSci Disposable Virus Sampling Tubes	2023-04-05
US	K220059	Biosci Inactivated Transport Medium, Biosci ITM	2023-01-19
BR	80430080026	Família Reagente Imunocromogênico	Class I
BR	80430080029	Família Solução de Lavagem	Class I
BR	80430080027	Família Solução para Recuperação de Antígenos	Class I

SHENZHEN DAKEWE BIO-ENGINEERING 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)

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