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Ascensia Diabetes Care U.S., Inc.

USA · Parsippany

✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Saudi Arabia, Canada — 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

n/aThis registry lists domestic registrants only

EUEuropean UnionEUDAMED

pendingnot queried

USUnited StatesFDA openFDA

10listed device types

Class I 3Class II 5Class III 2

plus 112 registration records and 12 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

0registered devices

this export covers Class I / II only (the cadastro route)

SASaudi ArabiaSFDA

1registered imported devices

low-risk imported devices only; a 2023 snapshot, not updated since

CACanadaMDALL

6active device licences

Class II 4Class III 2

20 including historic records

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 States112 registration records, 12 510(k), 0 PMA

Saudi Arabia1 confirmed, 0 excluded

Canada6 confirmed, 0 excluded

Manufacturer names merged into this page: Ascensia Diabetes Care US Inc. · Ascensia Diabetes Care Poland Sp. z o.o. · ASCENSIA DIABETES CARE HOLDINGS AG · Ascensia Diabetes Care Holdings AG

Same-named companies — This database also contains companies with near-identical names: ASCENSIA DIABETES CARE HOLDINGS AG, Ascensia Diabetes Care Poland Sp. z o.o.. Company name alone cannot separate their registrations, so the figures below may include either.

FDA 510(k) clearances by year

22016

12017

12019

22021

22022

32024

12025

FDA listed device types

showing 8 of 10

Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature 1Method, Enzymatic, Glucose (Urinary, Non-Quantitative) 1Multiple Use Blood Lancet For Single Patient Use Only 1System, Test, Blood Glucose, Over The Counter 1Glucose Dehydrogenase, Glucose 1Automated Insulin Dosing , Threshold Suspend 1Automated Insulin Dosing Device System, Single Hormonal Control 1Single (Specified) Analyte Controls (Assayed And Unassayed) 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K250813	MICROLET®NEXT 2 Lancing Device	2025-05-14
US	K241787	CONTOUR® PLUS BLUE Blood Glucose Monitoring System; CONTOUR® NEXT GEN Blood Glucose Monitoring System	2024-08-27
US	K241810	MICROLET®NEXT Lancet	2024-08-15
SA	ME0000013127SFDAA00001	Contour Diabetes app	—
CA	63019	GLUCOLET 2	Class II
CA	63050	FINGERSTIX LANCETS	Class II
CA	73607	BREEZE 2 BLOOD GLUCOSE MONITORING SYSTEM	Class III

Ascensia Diabetes Care U.S., 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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