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Simple Diagnostics, Inc.

USA · Maspeth

✓ Record-verifiedregistrations found in 1 markets

This company has registrations in United States — 1 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

pendingnot queried

USUnited StatesFDA openFDA

9listed device types

Class I 2Class II 7Class III 0

plus 9 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

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 States9 registration records, 3 510(k), 0 PMA, 9 excluded

Brazil0 confirmed, 3 excluded

Saudi Arabia0 confirmed, 1 excluded

Canada0 confirmed, 2 excluded

Manufacturer names merged into this page: SIMPLE DIAGNOSTICS

FDA 510(k) clearances by year

32012 · K122787

FDA listed device types

showing 8 of 9

Holding Chambers, Direct Patient Interface 1Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature 1System, Measurement, Blood-Pressure, Non-Invasive 1Nebulizer (Direct Patient Interface) 1Syringe, Piston 1Needle, Hypodermic, Single Lumen 1System, Test, Blood Glucose, Over The Counter 1Humidifier, Non-Direct Patient Interface (Home-Use) 1

Market	Identifier	Name	Class / date
US	K122787	COMFORT EZ	2012-12-06
US	K120921	CLEVER CHOICE	2012-08-21
US	K121632	COMFORT EZ	2012-08-10

Simple Diagnostics, 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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