FDA device listing
Ambu Mini Perfit Ace,Ambu Perfit,Ambu Perfit Ace,Ambu Redi Ace Adult,Ambu Redi Ace Mini
FDA device listing 1080107972 · AMBU A/S
Key facts
| Proprietary names | Ambu Mini Perfit Ace,Ambu Perfit,Ambu Perfit Ace,Ambu Redi Ace Adult,Ambu Redi Ace Mini |
|---|---|
| Owner/operator | AMBU A/S |
| Owner/operator number | 8010067 |
| Product codes | IQK |
| Device names | IQK - Orthosis, Cervical |
| Device class | Class I |
| Classification regulations (21 CFR) | 890.3490 |
| Review panels | Physical Medicine |
| Registered establishments | Ambu A/S, AMBU Limited |
| Establishment registrations | 9610691, 3003924186 |
| FEI numbers | 3002806359, 3003924186 |
| Establishment operations | Contract 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