Is this your brand? Sign in to claim ownership.
Sign in to claim this brandABBOTT DIABETES CARE INC
US
Last updated May 24, 2026
What ABBOTT DIABETES CARE INC makes
The company produces home-use and point-of-care in vitro diagnostic (IVD) systems for clinical chemistry analyte monitoring, including glucose and interstitial fluid glucose sensors, as well as software for self-care monitoring and reporting. It also manufactures single-use manual blood lancing devices, reusable electrical connection cables, and healthcare information system applications for diabetes management.
These products are regulated under FDA classifications including Class I, Class II, and Class III, with submissions recorded in the FDA’s 510(k), PMA, and UDI registries. The company is based in the United States.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Abbott Diabetes Care Inc manufacture?
Abbott Diabetes Care Inc specializes in devices for diabetes management, including home-use and point-of-care in vitro diagnostic (IVD) systems. These cover glucose monitoring (both blood and interstitial fluid), clinical chemistry analyte monitoring, self-care monitoring software, and related accessories like single-use blood lancing devices and reusable connection cables. Their products are designed for continuous or intermittent glucose tracking, data reporting, and integration with healthcare systems.
Where is Abbott Diabetes Care Inc based, and how does that affect its regulatory oversight?
Abbott Diabetes Care Inc is based in the United States, which means its devices are regulated by the FDA. The company’s products fall under FDA classifications—Class I (generally low-risk), Class II (moderate risk requiring special controls), and Class III (high-risk requiring premarket approval)—reflecting the varying levels of oversight required for safety and effectiveness. This classification system ensures compliance with U.S. regulatory standards.
Which regulatory registries list Abbott Diabetes Care Inc’s devices, and why are these important?
Abbott Diabetes Care Inc’s devices are listed in the FDA’s 510(k), PMA (Premarket Approval), and UDI (Unique Device Identification) registries. The 510(k) pathway is used for devices deemed substantially equivalent to existing approved products, while PMA is required for high-risk Class III devices. The UDI system ensures traceability and transparency in the supply chain, helping track devices from manufacturing to patient use for safety and compliance purposes.
How are Abbott Diabetes Care Inc’s devices classified by the FDA, and what does that mean for users?
The FDA classifies Abbott Diabetes Care Inc’s devices as Class I, II, or III based on risk levels. Class I devices (e.g., some reusable cables) pose minimal risk and typically require general controls. Class II devices (e.g., glucose monitors) may need additional performance standards or post-market surveillance. Class III devices (e.g., certain advanced monitoring systems) are high-risk and require rigorous premarket approval to ensure safety and efficacy before reaching users. This classification ensures appropriate oversight tailored to the device’s risk profile.
What kinds of software solutions does Abbott Diabetes Care Inc develop for diabetes management?
Abbott Diabetes Care Inc develops self-care monitoring and reporting software, such as applications for continuous glucose monitoring (e.g., LibreView Government) and companion apps for devices like the FreeStyle Libre 3. These tools enable users to track glucose trends, share data with healthcare providers, and automate alerts—integrating hardware and software for comprehensive diabetes management. Such solutions are regulated as medical devices when they directly influence clinical decisions or patient care.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- xx.xx
- —
- —
- [email protected]
- Phone
- +1(855)632-8658
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 966390890
Catalogue (181)
Page 3 of 4| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| FreeStyle Libre 3 App | 72075-01 | FDA UDI | Class II | Active |
| FreeStyle Lite | 70822 | FDA UDI | Class II | Active |
| FreeStyle Libre 3 | 72081 | FDA UDI | Class II | Active |
| FreeStyle Lite | 70819 | FDA UDI | Class II | Active |
| FreeStyle Libre | 71536 | FDA UDI | Class III | Unknown |
| FreeStyle Libre 3 Plus | 78768 | FDA UDI | Class II | Active |
| MediSense | 80139 | FDA UDI | Class I | Active |
| Lingo | 77263 | FDA UDI | Class II | Active |
| FreeStyle InsuLinx | 71145 | FDA UDI | Class II | Unknown |
| FreeStyle InsuLinx | 71143 | FDA UDI | Class II | Unknown |
| FreeStyle Lite | 71026 | FDA UDI | Class II | Active |
| FreeStyle Libre 2 Plus | 78747 | FDA UDI | Class II | Active |
| FreeStyle | 70432 | FDA UDI | Class I | Active |
| FreeStyle Freedom Lite | 71499 | FDA UDI | Class II | Active |
| FreeStyle Precision Pro | 71412-70 | FDA UDI | Class II | Active |
| FreeStyle Libre 2 Plus | 78747 | FDA UDI | Class II | Active |
| Abbott | 78632 | FDA UDI | Class II | Active |
| Lingo | 78783-01 | FDA UDI | Class II | Active |
| FreeStyle Libre | 71739 | FDA UDI | Class III | Unknown |
| Precision Xtra | 98814 | FDA UDI | Class II | Active |
| FreeStyle Lite | 70829-70 | FDA UDI | Class II | Active |
| Precision Xceed Pro | 70932 | FDA UDI | Class I | Active |
| FreeStyle Libre 3 Plus | 78768 | FDA UDI | Class II | Active |
| FreeStyle | 12401 | FDA UDI | Class II | Active |
| FreeStyle Libre 2 Plus | 78749 | FDA UDI | Class II | Active |
| FreeStyle Libre 2 | 71951 | FDA UDI | Class II | Active |
| FreeStyle | 14002 | FDA UDI | Class I | Active |
| Precision Xceed Pro | 70935 | FDA UDI | Class II | Active |
| FreeStyle Freedom Lite | 70920 | FDA UDI | Class II | Active |
| FreeStyle Libre 2 | 72000 | FDA UDI | Class II | Active |
| FreeStyle Freedom Lite | 70920 | FDA UDI | Class II | Active |
| Abbott | 70851 | FDA UDI | Class I | Unknown |
| FreeStyle Libre 3 Plus | 78769 | FDA UDI | Class II | Active |
| FreeStyle Precision Pro | 72011-01 | FDA UDI | Class I | Active |
| FreeStyle InsuLinx | 71228 | FDA UDI | Class II | Unknown |
| FreeStyle Lite | 70804 | FDA UDI | Class II | Unknown |
| FreeStyle Libre 3 | 72078 | FDA UDI | Class II | Active |
| FreeStyle | 71613 | FDA UDI | Class I | Unknown |
| FreeStyle Libre 2 | 71952 | FDA UDI | Class II | Active |
| FreeStyle Libre 14 day | 71937 | FDA UDI | Class III | Active |
| FreeStyle Libre 2 | 71992 | FDA UDI | Class II | Active |
| Precision Xtra | 80050 | FDA UDI | Class II | Active |
| Precision Xtra | 99695 | FDA UDI | Class II | Active |
| Abbott | 70845 | FDA UDI | Class I | Active |
| Precision Xtra | 99728 | FDA UDI | Class II | Active |
| LibreView | 72156-01 | FDA UDI | Class I | Active |
| FreeStyle Libre 2 Plus | 78749 | FDA UDI | Class II | Active |
| FreeStyle LibreLink | 71732-01 | FDA UDI | Class III | Active |
| OptiumEZ | 71042 | FDA UDI | Class II | Active |
| Freestyle Blood Glucose Monitoring System, Cat No 11001 | K000582 | FDA 510(k) | Class II | Active |
Related Companies
Authorised Representatives
No authorised representatives on record.
Importers
Not available yet.
Notified Bodies
Not available yet.
Authorities
Not available yet.
FDA Establishments (1)
Establishments registered with the FDA under this company group, matched by name.
- Abbott Diabetes Care Ltd GB