FDA device listing
GO PEE Kit,GO PEE Refill,Hygie Hy21 Urinal Support,Urinal Bag,Urinal Hygienic Cover,Urinal Kit,Uri ProHy21 Kit
FDA device listing 1650896165 · Hygie Canada Inc.
Key facts
| Proprietary names | GO PEE Kit,GO PEE Refill,Hygie Hy21 Urinal Support,Urinal Bag,Urinal Hygienic Cover,Urinal Kit,Uri ProHy21 Kit |
|---|---|
| Owner/operator | Hygie Canada Inc. |
| Owner/operator number | 10046551 |
| Product codes | FNP |
| Device names | FNP - Urinal |
| Device class | Class I |
| Classification regulations (21 CFR) | 880.6730 |
| Review panels | General Hospital |
| Registered establishments | Hygie Canada Inc. |
| Establishment registrations | 3008221237 |
| FEI numbers | 3008221237 |
| Establishment operations | Foreign Exporter, Manufacturer, Specification Developer |
| 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