FDA device listing
Fast Flex,Histoplast,Histoplast IM Paraffin,Histoplast LP Paraffin,Histoplast PE Paraffin,Paraffin Type 1,Paraffin Type…
FDA device listing 1675695104 · Epredia Holdings Ltd.
Key facts
| Proprietary names | Fast Flex,Histoplast,Histoplast IM Paraffin,Histoplast LP Paraffin,Histoplast PE Paraffin,Paraffin Type 1,Paraffin Type 3,Paraffin Type 6,Paraffin Type 9,Paraffin Type H,Paraffin Type L,Precision Cut Paraffin |
|---|---|
| Owner/operator | Epredia Holdings Ltd. |
| Owner/operator number | 10062642 |
| Product codes | KEO |
| Device names | KEO - Formulations, Paraffin, All |
| Device class | Class I |
| Classification regulations (21 CFR) | 864.4010 |
| Review panels | Pathology |
| Registered establishments | RICHARD-ALLAN SCIENTIFIC LLC |
| Establishment registrations | 1831638 |
| FEI numbers | 1831638 |
| Establishment operations | Contract Manufacturer, 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