FDA device listing
HF0024,HF0025,AGF65,HF0028,HF0029,HF0031,HF0032,HF0033,HF0034,HF0035,HF0036,HF0037,,HF0038,HF0039,HF0040,HF0041,HF0042,H…
FDA device listing 1572443910 · HEBEI MITA BIOTECHNOLOGY LIMITED
Key facts
| Proprietary names | HF0024,HF0025,AGF65,HF0028,HF0029,HF0031,HF0032,HF0033,HF0034,HF0035,HF0036,HF0037,,HF0038,HF0039,HF0040,HF0041,HF0042,HF0043,HF008,HF0023,HF009,HF0010,HF0011,HF0012,HF0013,HF0014,OMG135,HF0016,HF0018,HF0019,HF0020,,High Intensity Focused Ultrasound System:OM18,OM32… |
|---|---|
| Owner/operator | HEBEI MITA BIOTECHNOLOGY LIMITED |
| Owner/operator number | 10094693 |
| Product codes | ITX |
| Device names | ITX - Transducer, Ultrasonic, Diagnostic |
| Device class | Class II |
| Classification regulations (21 CFR) | 892.1570 |
| Review panels | Radiology |
| Registered establishments | HEBEI MITA BIOTECHNOLOGY LIMITED |
| Establishment registrations | 3043011436 |
| FEI numbers | 3043011436 |
| Establishment operations | 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