FDA device listing
Sim.LED 350,Sim.LED 3500+
FDA device listing 1896315202 · S.I.M.E.O.N. MEDICAL GmbH & Co. KG
Key facts
| Proprietary names | Sim.LED 350,Sim.LED 3500+ |
|---|---|
| Owner/operator | S.I.M.E.O.N. MEDICAL GmbH & Co. KG |
| Owner/operator number | 9093739 |
| Product codes | KYT |
| Device names | KYT - Light, Examination, Medical, Battery Powered |
| Device class | Class I |
| Classification regulations (21 CFR) | 880.6350 |
| Review panels | General Hospital |
| Registered establishments | S.I.M.E.O.N. MEDICAL GMBH & Co.KG, S.I.M.E.O.N. MEDICAL USA, LLC |
| Establishment registrations | 3006223081, 3012165496 |
| FEI numbers | 3006223081, 3012165496 |
| 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