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Prodigy Diabetes Care LLC

USA · Huntersville NC · www.prodigymeter.com

✓ Record-verifiedregistrations found in 4 markets

This company has registrations in United States, Canada, Taiwan, Israel — 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

12listed device types

Class I 2Class II 10Class III 0

plus 19 registration records and 3 510(k)

UKUnited KingdomMHRA PARD

0registered device records

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

1 including historic records

TWTaiwanTFDA

1valid device licences

Class I 1

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.

European Union307 raw hits, 300 excluded, 0 confirmed. Large result set — only the first 300 verified

United States19 registration records, 3 510(k), 0 PMA, 1 excluded

United Kingdom0 confirmed, 8 excluded

Brazil0 confirmed, 3 excluded

Manufacturer names merged into this page: PRODIGY DIABETES CARE, LLC

FDA 510(k) clearances by year

12011 · K103115

22013 · K122340

FDA listed device types

showing 8 of 12

Single (Specified) Analyte Controls (Assayed And Unassayed) 1Calculator/Data Processing Module, For Clinical Use 1Glucose Oxidase, Glucose 1Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature 1Hearing Aid, Air-Conduction With Wireless Technology, Over The Counter 1Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature 1Nebulizer (Direct Patient Interface) 1Syringe, Piston 1

Market	Identifier	Name	Class / date
US	K122340	PRODIGY CHOICE	2013-11-26
US	K122338	PREFERRED BLOOD GLUCOSE MONITORING SYSTEM	2013-11-05
US	K103115	PRODIGY DIABETES MANAGEMENT SOFTWARE	2011-10-12

Prodigy Diabetes Care LLC

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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