FDA device listing
Fast Warm NX
FDA device listing 1529661586 · FUJIFILM Holdings America Corporation
Key facts
| Proprietary names | Fast Warm NX |
|---|---|
| Owner/operator | FUJIFILM Holdings America Corporation |
| Owner/operator number | 2022379 |
| Product codes | MQL |
| Device names | MQL - Media, Reproductive |
| Device class | Class II |
| Classification regulations (21 CFR) | 884.6180 |
| Review panels | Obstetrics/Gynecology |
| Registered establishments | FUJIFILM Biosciences INC. |
| Establishment registrations | 2022379 |
| FEI numbers | 2022379 |
| Establishment operations | Contract 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