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VISGENEER, INC.

Taiwan · Hsinchu City

✓ Record-verifiedregistrations found in 2 markets

This company has registrations in United States, Russia — 2 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

7listed device types

Class I 3Class II 4Class III 0

plus 6 registration records and 3 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

0registered devices

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

2active registrations

Class 2a 1Class 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 States6 registration records, 3 510(k), 0 PMA

Manufacturer names merged into this page: VISGENEER, INC.

FDA 510(k) clearances by year

12006 · K062555

12010 · K091765

12013 · K122181

FDA listed device types

Multiple Use Blood Lancet For Single Patient Use Only 1Glucose Oxidase, Glucose 1Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature 1System, Test, Blood Glucose, Over The Counter 1Single (Specified) Analyte Controls (Assayed And Unassayed) 1Enzymatic Esterase--Oxidase, Cholesterol 1Nitroprusside, Ketones (Urinary, Non-Quant.) 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K122181	EBCHEK BLOOD GLUCOSE MONITORING SYSTEM	2013-08-15
US	K091765	EBCARRYON BLOOD GLUCOSE MONITORING SYSTEM	2010-01-19
US	K062555	EBSENSOR BLOOD GLUCOSE MONITORING SYSTEM, MODEL EB-G	2006-12-27

VISGENEER, 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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