Home›Taiwan›Apex Biotechnology Corporation

Apex Biotechnology Corporation

✓ Record-verifiedregistrations found in 6 markets

This company has registrations in United States, United Kingdom, Brazil, Australia, Hong Kong, Israel — 6 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

0UDI-DI device records

USUnited StatesFDA openFDA

9listed device types

Class I 5Class II 4Class III 0

plus 18 registration records and 35 510(k)

UKUnited KingdomMHRA PARD

12registered device records

IVD general 6IVD Devices for Self-Testing 6

BRBrazilANVISA

8registered devices

Class I 1Class II 7

16 including historic records

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

2active ARTG entries

IVD Class 1 1IVD Class 3 1

HKHong KongMDACS

1valid listings

IVD C 1

ILIsraelAMAR

1registrations

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 States18 registration records, 35 510(k), 0 PMA, 26 excluded

United Kingdom12 confirmed, 8 excluded

Brazil8 confirmed, 3 excluded

Canada0 confirmed, 2 excluded

Manufacturer names merged into this page: APEX BIOTECHNOLOGY CORP. · APEX BIOTECHNOLOGY CORPORATION · APEX BIOTECHNOLOGY CORP

Regulatory identity

UK responsible person: Obelis UK Ltd

FDA 510(k) clearances by year

32001

22007

22008

12009

22010

32011

52012

12014

42015

12016

12017

22018

22021

52022

12025

FDA listed device types

showing 8 of 9

Prescription Use Blood Glucose Meter For Near-Patient Testing 1Glucose Dehydrogenase, Glucose 1Glucose Oxidase, Glucose 1System, Test, Blood Glucose, Over The Counter 1Acid, Lactic, Enzymatic Method 1Calculator/Data Processing Module, For Clinical Use 1Nitroprusside, Ketones (Urinary, Non-Quant.) 1Uric Acid Test System For At Home Prescription Use 1

Registration details (sample)

Market	Identifier	Name	Class / date
UK	62740	Eclipse Plus Urine Control Solution	IVD general
UK	62741	Eclipse Plus ACR Reagent Kit	IVD general
UK	53252	Eclipse Plus Creatinine Reagent Kit	IVD general
US	K242209	UASure II Blood Uric Acid Monitoring System	2025-04-04
US	K222234	GlucoSure ADVANCE Link Blood Glucose Monitoring System	2022-12-21
US	K220421	BGM039 Blood Glucose Monitoring System, BGM039 Link Blood Glucose Monitoring System	2022-11-04
BR	80117580778	Família Tiras teste de Hemoglobina	Class II
BR	80117580752	Família ApexBio Eclipse A1c Hemoglobin A1c POC Analyzer	Class II
BR	80117580759	Família Medidor HemoSmart GOLD	Class II

Apex Biotechnology Corporation

Registrations by market

How these numbers were verified

Regulatory identity

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

Similar companies