FDA device listing
Sampler, Amniotic Fluid (Amniocentesis Tray) - DeRoyal
FDA device listing 1756141214 · DEROYAL INDUSTRIES, INC.
Key facts
| Proprietary names | Sampler, Amniotic Fluid (Amniocentesis Tray) - DeRoyal |
|---|---|
| Owner/operator | DEROYAL INDUSTRIES, INC. |
| Owner/operator number | 1044833 |
| Product codes | HIO |
| Device names | HIO - Sampler, Amniotic Fluid (Amniocentesis Tray) |
| Device class | Class I |
| Classification regulations (21 CFR) | 884.1550 |
| Review panels | Obstetrics/Gynecology |
| Registered establishments | DeRoyal Industries, Inc., DEROYAL INDUSTRIES, INC. |
| Establishment registrations | 1043214, 1054241, 1055236 |
| FEI numbers | 1043214, 1000112877, 1000112968 |
| Establishment operations | Complaint File Establishment, Specification Developer, 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