FDA device listing
HMEs, Shower guard, StomaGrips, All starter and home kits, TouchFree HMEs
FDA device listing 1257129107 · Eon Meditech Pvt. Ltd.
Key facts
| Proprietary names | HMEs, Shower guard, StomaGrips, All starter and home kits, TouchFree HMEs |
|---|---|
| Owner/operator | Eon Meditech Pvt. Ltd. |
| Owner/operator number | 10085729 |
| Product codes | BYD |
| Device names | BYD - Condenser, Heat And Moisture (Artificial Nose) |
| Device class | Class I |
| Classification regulations (21 CFR) | 868.5375 |
| Review panels | Anesthesiology |
| Registered establishments | EON MEDITECH PVT. LTD. |
| Establishment registrations | 3023464160 |
| FEI numbers | 3023464160 |
| 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