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ASCENSIA DIABETES CARE US INC.

US

Last updated September 17, 2026

Information

Country
US
Address
100 Summit Lake Drive, Valhalla, NY, 10595
Website
contournext.com
LinkedIn
—
Facebook
—
Email
[email protected]
Phone
18003488100
PRRC Contact
—
EUDAMED SRN
—
FDA FEI Number
1810909
DUNS Number
080028910

Catalogue (101)

Page 1 of 3
DeviceModel / ReferenceRegistriesClassStatus
Contour® 7110B
FDA UDI
Class IIUnknown
Contour® Plus 7594
FDA UDI
Class IIActive
Contour® 9556C
FDA UDI
Class IIActive
Contour® Next One 7818
FDA UDI
Class IIUnknown
Contour® Next One 9765
FDA UDI
Class IIActive
Microlet®next 6705
FDA UDI
Class IIActive
CONTOUR® NEXT and MICROLET® 7751
FDA UDI
Class IIUnknown
Contour® Next One 9766
FDA UDI
Class IIUnknown
Contour® 7070A
FDA UDI
Class IIUnknown
Contour® Next Ez 7553
FDA UDI
Class IIActive
Contour® Next Link 9624
FDA UDI
Class IUnknown
CONTOUR® NEXT ONE, CONTOUR® NEXT and MICROLET® 9780
FDA UDI
Class IIUnknown
Contour® Next Link 2.4 6262
FDA UDI
Class IIIActive
Breeze® 2 1490A
FDA UDI
Class IUnknown
Contour® 7097C
FDA UDI
Class IIUnknown
Diastix® 2803
FDA UDI
Class IIActive
Contour® Next Gen 7383
FDA UDI
Class IIActive
Contour® Diabetes App 3537
FDA UDI
Class IIActive
Contour® Next Link 9632
FDA UDI
Class IUnknown
Contour® 7098C
FDA UDI
Class IIActive
Contour® Next 7308
FDA UDI
Class IIUnknown
Contour® Next 9697
FDA UDI
Class IUnknown
Contour® Next One 9550
FDA UDI
Class IIUnknown
Contour® 7111B
FDA UDI
Class IIUnknown
Contour® Next Gen 9732
FDA UDI
Class IIUnknown
Contour® Next 7283
FDA UDI
Class IIIUnknown
Contour® Plus Blue 7035
FDA UDI
Class IIUnknown
Contour® Next Gen 9732
FDA UDI
Class IIActive
Microlet® 6586 / 6586W
FDA UDI
Class IIActive
Contour® 9545C
FDA UDI
Class IIUnknown
Contour® Next One 7828
FDA UDI
Class IIActive
Contour® Next 7377
FDA UDI
Class IActive
Contour® Next 7379
FDA UDI
Class IActive
CONTOUR® NEXT EZ, CONTOUR® NEXT GEN and CONTOUR® NEXT 9660
FDA UDI
Class IIUnknown
Contour® Plus 9563
FDA UDI
Class IIActive
Contour® 7109B
FDA UDI
Class IIUnknown
Contour® Plus 7584
FDA UDI
Class IIActive
Contour® Next One 9763
FDA UDI
Class IIUnknown
Contour® Next Gen 7922
FDA UDI
Class IIActive
Contour® Next Ez 9628
FDA UDI
Class IIActive
Ketostix® 2880
FDA UDI
Class IActive
Contour® 7080G
FDA UDI
Class IIActive
Breeze® 2 1466A
FDA UDI
Class IIUnknown
Contour® Next Gen 7917
FDA UDI
Class IIActive
Breeze® 2 1468A
FDA UDI
Class IIUnknown
Contour® Plus Blue 7035
FDA UDI
Class IIActive
CONTOUR®NEXT and MICROLET® 9782
FDA UDI
Class IIUnknown
Keto-Diastix® 2882
FDA UDI
Class IIActive
Abound® 7770
FDA UDI
Class IIUnknown
Keto-Diastix® 2883
FDA UDI
Class IIActive

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Notified Bodies

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Authorities

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FDA Recalls (1)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

DateRecall No.ClassStatusReason
May 19, 2023Z-2211-2023—open, classified

Ascensia Diabetes Care has determined through customer complaints that 580 of 2900 meters from lot number DM01T033P are reconfigured from mg/dL to mmol/L. Among them, 579 meters distributed in the United States were packaged into the meter kit and had incorrect factory-set unit of measure where the meters display glucose results in mmol/L rather than mg/dL. The standard unit of measurement for the United States is mg/dL. If a consumer does not notice the incorrect unit of measurement, it is possible that the meters glucose measurement will be read as a lower blood glucose measurement than expected, and this may result in the patients glucose level remaining high, which can potentially lead to an injury requiring immediate medical intervention.