FDA device listing
Contour Next Blood Glucose Test Strips,Contour Next Link 2.4 Wireless Blood Glucose Meter,Contour Next Link 2.4 Wireless…
FDA device listing 1492555049 · Ascensia Diabetes Care Holdings AG
Key facts
| Proprietary names | Contour Next Blood Glucose Test Strips,Contour Next Link 2.4 Wireless Blood Glucose Meter,Contour Next Link 2.4 Wireless Blood Glucose Monitoring System |
|---|---|
| Owner/operator | Ascensia Diabetes Care Holdings AG |
| Owner/operator number | 10050965 |
| Premarket submissions | P150001 |
| Product codes | OZO |
| Device names | OZO - Automated Insulin Dosing , Threshold Suspend |
| Device class | Class III |
| Classification regulations (21 CFR) | ORCA1.OZO |
| Review panels | Clinical Chemistry |
| Registered establishments | ASCENSIA DIABETES CARE HOLDINGS AG, Ascensia Diabetes Care Poland Sp. z o.o., Ascensia Diabetes Care US Inc. |
| Establishment registrations | 1810909, 3011121740, 3012118659, 3038419886 |
| FEI numbers | 1810909, 3010700165, 3012118659, 3038419886 |
| Establishment operations | Complaint File Establishment, Specification Developer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- 100–999 UDI devices (GUDID) under the same submission
- 1–9 Device listings citing the same submission
- Yes Premarket submission listed
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device listings
Establishments that make or process devices for the U.S. market must list each device with the FDA. A listing records the device's proprietary names, product codes and premarket submission, and every registered establishment that handles it.
Source: U.S. Food and Drug Administration (FDA), Establishment Registration and Device Listing database