FDA device listing
ALINA 6M, ALINA 6M WITH BATTERY BACK-UP,GALAXY INDIA Surgical Examination Light Mobile,KIARA 12M, KIARA 12M WITH BATTERY…
FDA device listing 2038383221 · GALAXY INDIA
Key facts
| Proprietary names | ALINA 6M, ALINA 6M WITH BATTERY BACK-UP,GALAXY INDIA Surgical Examination Light Mobile,KIARA 12M, KIARA 12M WITH BATTERY BACK-UP, KIARA 9M, KIARA 9M WITH BATTERY BACK-UP, KIARA 6M,,KIARA 6M WITH BATTERY BACK-UP, ALINA 12M, ALINA 12M WITH BATTERY BACK-UP, ALINA 9M, ALINA 9M WITH BATTERY BACK-UP |
|---|---|
| Owner/operator | GALAXY INDIA |
| Owner/operator number | 10059711 |
| Product codes | KZF |
| Device names | KZF - Device, Medical Examination, Ac Powered |
| Device class | Class I |
| Classification regulations (21 CFR) | 880.6320 |
| Review panels | General Hospital |
| Registered establishments | GALAXY INDIA |
| Establishment registrations | 3015223105 |
| FEI numbers | 3015223105 |
| Establishment operations | 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