FDA device listing
LABOMED PRIMA mu,LABOMED PRIMA OPH,LABOMED STELLA OPH
FDA device listing 1980581182 · LABOTECH MICROSCOPES INDIA PRIVATE LIMITED
Key facts
| Proprietary names | LABOMED PRIMA mu,LABOMED PRIMA OPH,LABOMED STELLA OPH |
|---|---|
| Owner/operator | LABOTECH MICROSCOPES INDIA PRIVATE LIMITED |
| Owner/operator number | 9095581 |
| Product codes | HRM |
| Device names | HRM - Microscope, Operating & Accessories, Ac-Powered, Ophthalmic |
| Device class | Class I |
| Classification regulations (21 CFR) | 878.4700 |
| Review panels | General & Plastic Surgery |
| Registered establishments | LABOTECH MICROSCOPES INDIA PRIVATE LIMITED |
| Establishment registrations | 3005527296 |
| FEI numbers | 3005527296 |
| 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