FDA device listing
Telligence,Unite Connect For Nurse Call,Unite View
FDA device listing 2030979417 · ASCOM SWEDEN AB
Key facts
| Proprietary names | Telligence,Unite Connect For Nurse Call,Unite View |
|---|---|
| Owner/operator | ASCOM SWEDEN AB |
| Owner/operator number | 10037837 |
| Product codes | IQA |
| Device names | IQA - System, Environmental Control, Powered |
| Device class | Class II |
| Classification regulations (21 CFR) | 890.3725 |
| Review panels | Physical Medicine |
| Registered establishments | ASCOM SWEDEN AB, ASCOM US, INC. |
| Establishment registrations | 3008855170, 3008952681 |
| FEI numbers | 3008855170, 3008952681 |
| Establishment operations | Complaint File Establishment, 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