FDA device listing
Ambu BlueSensor,Ambu WhiteSensor,ECG Electrodes
FDA device listing 1029881618 · AMBU A/S
Key facts
| Proprietary names | Ambu BlueSensor,Ambu WhiteSensor,ECG Electrodes |
|---|---|
| Owner/operator | AMBU A/S |
| Owner/operator number | 8010067 |
| Product codes | DRX |
| Device names | DRX - Electrode, Electrocardiograph |
| Device class | Class II |
| Classification regulations (21 CFR) | 870.2360 |
| Review panels | Cardiovascular |
| Registered establishments | Ambu A/S, AMBU SDN.BHD. |
| Establishment registrations | 9610691, 3004040397 |
| FEI numbers | 3002806359, 3004040397 |
| Establishment operations | Contract Manufacturer, Foreign Exporter, Foreign Private Label Distributor, Specification Developer |
| 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