FDA device listing
Integrated Continuous Glucose Monitoring System With Sensor Containing Dexamethasone Acetate
FDA device listing 1762181131 · Andersen Caledonia Ltd
Key facts
| Owner/operator | Andersen Caledonia Ltd |
|---|---|
| Owner/operator number | 10043114 |
| Product codes | SBA |
| Device names | SBA - Integrated Continuous Glucose Monitoring System With Sensor Containing Dexamethasone Acetate |
| Device class | Class II |
| Classification regulations (21 CFR) | 862.1357 |
| Review panels | Clinical Chemistry |
| Registered establishments | ANDERSEN CALEDONIA LTD |
| Establishment registrations | 3004530184 |
| FEI numbers | 3004530184 |
| Establishment operations | Contract Sterilizer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- None listed 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