FDA device listing
Chest suction electrodes, Limb clamps electrodes, Disposable ECG monitoring electrodes, Prewired neonate ECG electrodes
FDA device listing 2025237967 · Orantech Inc.
Key facts
| Proprietary names | Chest suction electrodes, Limb clamps electrodes, Disposable ECG monitoring electrodes, Prewired neonate ECG electrodes |
|---|---|
| Owner/operator | Orantech Inc. |
| Owner/operator number | 10058634 |
| Product codes | DRX |
| Device names | DRX - Electrode, Electrocardiograph |
| Device class | Class II |
| Classification regulations (21 CFR) | 870.2360 |
| Review panels | Cardiovascular |
| Registered establishments | ORANTECH INC. |
| Establishment registrations | 3013783488 |
| FEI numbers | 3013783488 |
| Establishment operations | Foreign Exporter, Manufacturer |
| 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