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Allmedicus Co., Ltd.

Korea, Republic · Anyang-si Gyeonggi-do · www.allmedicus.com

✓ Record-verifiedregistrations found in 4 markets

This company has registrations in United States, Brazil, Canada, 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

n/aThis registry lists domestic registrants only

EUEuropean UnionEUDAMED

0UDI-DI device records

USUnited StatesFDA openFDA

6listed device types

Class I 1Class II 5Class III 0

plus 5 registration records and 5 510(k)

UKUnited KingdomMHRA PARD

0registered device records

BRBrazilANVISA

1registered devices

Class II 1

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

1active device licences

Class III 1

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

pendingnot queried

RURussiaRoszdravnadzor

3active registrations

Class 2a 2Class 2b 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 States5 registration records, 5 510(k), 0 PMA, 4 excluded

Brazil1 confirmed, 0 excluded

Canada1 confirmed, 0 excluded

Manufacturer names merged into this page: All Medicus Co., Ltd. · ALL MEDICUS CO., LTD. · ALL MEDICUS CO., LTD

FDA 510(k) clearances by year

12005 · K050985

22009 · K083628

12013 · K130657

12017 · K170241

FDA listed device types

Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature 1Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature 1Multiple Use Blood Lancet For Single Patient Use Only 1System, Test, Blood Glucose, Over The Counter 1Glucose Dehydrogenase, Glucose 1Single (Specified) Analyte Controls (Assayed And Unassayed) 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K170241	GlucoDr.S Blood Glucose Monitoring System, GlucoDr.S BLE Blood Glucose Monitoring System, GlucoDr.S NFC Blood Glucose Monitoring System	2017-10-13
US	K130657	LINKDR 2.0 DIABETES MANAGEMENT SOFTWARE	2013-07-15
US	K083628	GLUCODR AUTO SYSTEM	2009-05-01
BR	80133200043	SOLUÇÃO DE CONTROLE GLUCO DR SUPER SENSOR	Class II
CA	92218	GLUCODR AUTO BLOOD GLUCOSE MONITORING SYSTEM	Class III

Allmedicus 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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