FDA Registration
Active
🇺🇸 United States
S.I.M.E.O.N. MEDICAL USA, LLC
Reg #: 3012165496
·
FEI: 3012165496
·
Expires 2026
Products
7
Proprietary Names
27
Establishment Types
1
Classifications
7
Registration Details
- Registration Name
- S.I.M.E.O.N. MEDICAL USA, LLC
- Registration Number
- 3012165496
- FEI Number
- 3012165496
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 33 Market Point Drive
- City
- Greenville
- State
- SC
- ZIP
- 29607
- Country
- US
Owner / Operator
- Firm Name
- S.I.M.E.O.N. MEDICAL GmbH & Co. KG
- Operator Number
- 9093739
- Address
- In Grubenacker 18, --
- City
- TUTTLINGEN
- State
- Baden-Wurttemberg
- Postal Code
- 78532
- Country
- DE
- Correspondent
- Andreas - Muehlenbeck
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Table, Operating-Room, Electrical | GDC | Class 1 | General, Plastic Surgery | No | 2021-02-17 |
| Light, Surgical, Floor Standing | FSS | Class 2 | General, Plastic Surgery | No | 2014-09-08 |
| Light, Surgical, Accessories | FTA | Class 2 | General, Plastic Surgery | No | 2025-02-10 |
| Light, Examination, Medical, Battery Powered | KYT | Class 1 | General Hospital | No | 2021-11-25 |
| Light, Surgical, Ceiling Mounted | FSY | Class 2 | General, Plastic Surgery | No | 2014-09-08 |
| Device, Medical Examination, Ac Powered | KZF | Class 1 | General Hospital | No | 2012-12-20 |
| Camera, Surgical And Accessories | KQM | Class 1 | General, Plastic Surgery | No | 2012-12-20 |
Proprietary Names
Sim.MOVE 800
Sim.LED 7000 MC
Sim.LED 7000 SC
Sim.LED 4500
Sim.LED 5000 MC
Sim.LED 5000 SC
Sim.LED 500 MC
Sim.LED 500 SC
Sim.LED 700 SC
Sim.LED 700 MC
Sim.LED 450 SC
Sim.LED 450 MC
Sim.LED 8000 SC
Sim.LED 8000 MC
Light, Surgical_Wall Mounted
Sim.LED 3500+
Sim.LED 350
Sim. LED 5000 MC
Sim. LED 7000 MC
Sim. LED 5000 SC
Sim. LED 7000 SC
Sim.CAM SD
Sim.CAM HD TOUCH
Sim.CAM HD
Sim.CAM 4K
Sim.CAM HD Wireless
Sim.CAM 4K Wireless
Establishment Types
Complaint File Establishment per 21 CFR 820.198