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B&E BIO-TECHNOLOGY CO., LTD.

China · Yantai Shandong

✓ 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

9listed device types

Class I 7Class II 2Class III 0

plus 9 registration records and 0 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

4registered devices

Class II 4

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

1active registrations

Class 2a 1

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 States9 registration records, 0 510(k), 0 PMA, 288 excluded

Brazil4 confirmed, 122 excluded

Saudi Arabia0 confirmed, 23 excluded

Canada0 confirmed, 42 excluded

Manufacturer names merged into this page: B&E BIO-TECHNOLOGY CO., LTD.

FDA listed device types

showing 8 of 9

Diluent, Blood Cell 1Detergent 1Nitroprusside, Ketones (Urinary, Non-Quant.) 1General Purpose Reagent 1Stains, Dye Solution 1Products, Red-Cell Lysing Products 1Stains, Hematology 1Calibrator For Cell Indices 1

Registration details (sample)

Market	Identifier	Name	Class / date
BR	81154840012	Família de Analisadores de Eletrólitos Iontech	Class II
BR	81154840014	Pack de reagentes para analisador de eletrólitos Iontech 400	Class II
BR	81154840015	Pack de reagentes para analisador de eletrólitos Iontech 500	Class II

B&E BIO-TECHNOLOGY CO., LTD.

Registrations by market

How these numbers were verified

Company information

FDA listed device types

Registration details (sample)

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