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HMD BioMedical Inc.

Taiwan · Hsinchu · www.hmdbio.com

✓ Record-verifiedregistrations found in 3 markets

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

0UDI-DI device records

USUnited StatesFDA openFDA

12listed device types

Class I 7Class II 4Class III 0unclassified 1

plus 17 registration records and 11 510(k)

UKUnited KingdomMHRA PARD

0registered device records

BRBrazilANVISA

23registered devices

Class I 11Class II 12

30 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

pendingnot queried

HKHong KongMDACS

pendingnot queried

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 States17 registration records, 11 510(k), 0 PMA, 1 excluded

Brazil23 confirmed, 1 excluded

Canada0 confirmed, 1 excluded

Manufacturer names merged into this page: HMD BIOMEDICAL, INC. · HMD BIOMEDICAL INC. · HMD BIOMEDICAL INC

FDA 510(k) clearances by year

22003

12008

32012

12013

12014

12015

12019

12022

FDA listed device types

showing 8 of 12

Glucose Dehydrogenase, Glucose 1Glucose Oxidase, Glucose 1Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature 1System, Test, Blood Glucose, Over The Counter 1Acid, Uric, Acid Reduction Of Ferric Ion 1Calculator/Data Processing Module, For Clinical Use 1Accessory, Surgical Apparel 1Nitroprusside, Ketones (Urinary, Non-Quant.) 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K212248	GlucoLeader Enhance 2 Blood Glucose Monitoring System	2022-08-29
US	K182428	GlucoLeader Enhance Blood Glucose Monitoring System	2019-05-08
US	K140150	Goodlife AC-300 Blood Glucose Monitoring System, Goodlife AC-301 Blood Glucose Monitoring System, Goodlife AC-302 Blood Glucose Monitoring System, Goodlife AC 303 Blood Glucose Monitoring System, Goodlife AC-304 Blood Glucose Monitoring System Goodlife AC-305 Blood Glucose Monitoring System, Goodlife AC-300 Professional Blood Glucose Monitoring System, Goodlife AC-301 Professional Blood Glucose Monitoring System Goodlife AC-30	2015-05-14
BR	82765289001	LANCETAS DE SEGURANÇA OK BIOTECH	Class II
BR	82765289002	LANCETA TWIST GLUCOLEADER HU	Class II
BR	80867159015	Agulha Descartável para Caneta de Insulina HMD	Class II

HMD BioMedical Inc.

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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