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ACON Laboratories, Inc.

✓ Record-verifiedregistrations found in 9 markets

This company has registrations in United States, United Kingdom, Brazil, Canada, Taiwan, Singapore, Hong Kong, Israel, Russia — 9 overseas markets. The China NMPA lookup is still pending.

Registrations by market

Each market counts a different unit; figures are not directly comparable

CNChinaNMPA

n/aThis registry lists domestic registrants only

EUEuropean UnionEUDAMED

0UDI-DI device records

USUnited StatesFDA openFDA

31listed device types

Class I 19Class II 11Class III 0unclassified 1

plus 32 registration records and 93 510(k)

UKUnited KingdomMHRA PARD

75registered device records

Class I 1Class IIa 1IVD A 4IVD general 43IVD Annex II List B 3IVD Devices for Self-Testing 23

BRBrazilANVISA

12registered devices

Class I 2Class II 10

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

15 including historic records

TWTaiwanTFDA

2valid device licences

Class II 2

SGSingaporeHSA SMDR

7device registrations

CLASS B 6CLASS C 1

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

1valid listings

IVD B 1

ILIsraelAMAR

12registrations

RURussiaRoszdravnadzor

2active registrations

Class 2b 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.

European Union3,289 raw hits, 300 excluded, 0 confirmed. Large result set — only the first 300 verified

United States32 registration records, 93 510(k), 0 PMA, 2 excluded

United Kingdom75 confirmed, 9 excluded

Brazil12 confirmed, 5 excluded

Manufacturer names merged into this page: ACON LABORATORIES, INC. · ACON LABORATORIES, INC

Regulatory identity

UK responsible person: MDSS-UK RP LIMITED

FDA 510(k) clearances by year

102004

72005

42006

32007

12009

22010

32011

62012

32013

22014

32015

12016

22017

32018

22019

12020

12023

22024

42025

12026

FDA listed device types

showing 8 of 31

Test, Luteinizing Hormone (Lh), Over The Counter 1Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.) 1Refractometer For Clinical Use 1Ldl & Vldl Precipitation, Hdl 1Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.) 1Colorimetric Method, Triglycerides 1Single (Specified) Analyte Controls (Assayed And Unassayed) 1Automated Urinalysis System 1

Registration details (sample)

Market	Identifier	Name	Class / date
UK	62740	On Call MultiPro ACR Controls	IVD general
UK	62751	OnCall MultriPro ACR Test Kit	IVD general
UK	61579	Insight Lancets	Class IIa
US	K261212	Flowflex Plus RSV + Flu A/B + COVID Rapid Test	2026-07-10
US	K251697	Flowflex® Plus Strep A Rapid Test Cassette; Flowflex® Plus Strep A Rapid Test Strip	2025-11-26
US	K251749	Flowflex Plus RSV + Flu A/B + COVID Home Test	2025-10-22
BR	81327670103	Dispositivo de Controle da hemoglobina (Hb) Mission® Plus	Class II
BR	81327670104	Medidor de Hemoglobina Hb Mission Plus	Class II
BR	81327670105	Solução Controle de Hemoglobina Hb Mission®	Class II