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Sign in to claim this brandASCENSIA DIABETES CARE US INC.
US
Last updated September 17, 2026
Information
- Country
- US
- Address
- 100 Summit Lake Drive, Valhalla, NY, 10595
- Website
- contournext.com
- —
- —
- [email protected]
- Phone
- 18003488100
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- 1810909
- DUNS Number
- 080028910
Catalogue (101)
Page 2 of 3| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Ketostix® | 2881 | FDA UDI | Class I | Active |
| Contour® Next Gen | 9658 | FDA UDI | Class II | Unknown |
| Contour® Plus | 7593 | FDA UDI | Class II | Active |
| Contour® Next Ez | 7252 | FDA UDI | Class II | Active |
| CONTOUR® NEXT and MICROLET® | 9769 | FDA UDI | Class II | Unknown |
| Contour® Next | 7314 | FDA UDI | Class I | Active |
| Contour® Next Link | 9740 | FDA UDI | Class I | Unknown |
| Abound® | 7750 | FDA UDI | Class II | Unknown |
| Contour® Next Ez | 9628 | FDA UDI | Class II | Unknown |
| Contour® Next One | 7825 | FDA UDI | Class II | Active |
| CONTOUR® NEXT EZ and CONTOUR® NEXT | 5534 | FDA UDI | Class II | Unknown |
| Microlet®next | 6721 | FDA UDI | Class II | Active |
| Contour® Next Link | 6201 | FDA UDI | Class I | Unknown |
| Breeze® 2 | 1467A | FDA UDI | Class II | Unknown |
| Contour®next | 7550 | FDA UDI | Class III | Active |
| Contour® Next | 7277 | FDA UDI | Class II | Active |
| Contour® Next | 7312 | FDA UDI | Class III | Active |
| Contour® Next Link | 6207 | FDA UDI | Class I | Unknown |
| Microlet®next | 6702 | FDA UDI | Class II | Active |
| Contour® Next | 7311 | FDA UDI | Class II | Active |
| Contour® | 7099C | FDA UDI | Class II | Unknown |
| Contour® | 7151H | FDA UDI | Class II | Unknown |
| CONTOUR® NEXT and MICROLET® | 7771 | FDA UDI | Class II | Unknown |
| CONTOUR® NEXT ONE, CONTOUR® NEXT EZ, and CONTOUR® NEXT | 9647 | FDA UDI | Class II | Unknown |
| CONTOUR® NEXT ONE, CONTOUR® NEXT and MICROLET® | 9768 | FDA UDI | Class II | Unknown |
| Contour® Next One | 7824 | FDA UDI | Class II | Unknown |
| Contour® Next | 7310 | FDA UDI | Class II | Active |
| Contour® | 9507C | FDA UDI | Class II | Unknown |
| Contour® Plus Blue | 7036 | FDA UDI | Class II | Active |
| Diastix® | 2806 | FDA UDI | Class II | Active |
| Contour® Next Link 2.4 | 6260 | FDA UDI | Class III | Active |
| Contour® Next | 7278 | FDA UDI | Class II | Active |
| Contour® Next | 7313 | FDA UDI | Class II | Active |
| Contour® Next | 7309 | FDA UDI | Class III | Active |
| Contour® | 7189 | FDA UDI | Class II | Unknown |
| Breeze® 2 | 1489A | FDA UDI | Class I | Unknown |
| Contour® Next | 7315 | FDA UDI | Class I | Active |
| Contour® Next One | 9767 | FDA UDI | Class II | Unknown |
| Contour® Next Link | 6203 | FDA UDI | Class I | Unknown |
| Glucofacts® Deluxe | 3515 | FDA UDI | Class I | Active |
| Breeze® 2 | 1491A | FDA UDI | Class I | Unknown |
| CONTOUR®NEXT and MICROLET® | 9781 | FDA UDI | Class II | Unknown |
| Contour® Diabetes App | 3536 | FDA UDI | Class II | Active |
| Breeze® 2 | 1465A | FDA UDI | Class II | Unknown |
| MICROLET NEXT lancing device, MICROLET Lancet | K220633 | FDA 510(k) | Class II | Active |
| Contour Next Link Wireless Blood Glucose Monitoring System, Contour Next Blood Glucose Monitoring System | K160430 | FDA 510(k) | Class II | Active |
| CONTOUR® NEXT GEN Blood Glucose Monitoring System | K223293 | FDA 510(k) | Class II | Active |
| MICROLET®NEXT Lancet | K241810 | FDA 510(k) | Class II | Active |
| CONTOUR® PLUS BLUE Blood Glucose Monitoring System; CONTOUR® NEXT GEN Blood Glucose Monitoring System | K241787 | FDA 510(k) | Class II | Active |
| MICROLET®NEXT 2 Lancing Device | K250813 | FDA 510(k) | Class II | Active |
Related Companies
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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.
| Date | Recall No. | Class | Status | Reason |
|---|---|---|---|---|
| May 19, 2023 | Z-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. |