FDA device listing
MTI; Lumerus Exam Light, Clarus 4 Exam Light, Clarus 7 Exam Light, Halogen Exam Light
FDA device listing 1116144286 · Medical Technology Industries, Inc.
Key facts
| Proprietary names | MTI; Lumerus Exam Light, Clarus 4 Exam Light, Clarus 7 Exam Light, Halogen Exam Light |
|---|---|
| Owner/operator | Medical Technology Industries, Inc. |
| Owner/operator number | 9041680 |
| 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 | MEDICAL TECHNOLOGY INDUSTRIES, INC. |
| Establishment registrations | 1724810 |
| FEI numbers | 3003057333 |
| Establishment operations | Repackager/Relabeler |
| 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