FDA Registration
Active
🇩🇪 Germany
S.I.M.E.O.N. MEDICAL GMBH & Co.KG
Reg #: 3006223081
·
FEI: 3006223081
·
Expires 2026
Products
7
Proprietary Names
27
Establishment Types
3
Classifications
7
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Registration Details
- Registration Name
- S.I.M.E.O.N. MEDICAL GMBH & Co.KG
- Registration Number
- 3006223081
- FEI Number
- 3006223081
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- In Grubenacker 18
- City
- TUTTLINGEN Baden-Wurttemberg
- Country
- DE
Regulatory Submissions
- 510(k) Number
- K060802
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
US Agent
- Business Name
- MEDAGENT Inc.
- Contact Name
- Franz Menean
- Address
- 264 Lafayette Rd Ste 7
- City
- Portsmouth
- State
- NH
- ZIP
- 03801
- Country
- US
- [email protected]
- Phone
- 603 5702039
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| 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 | 2012-12-12 |
| Camera, Surgical And Accessories | KQM | Class 1 | General, Plastic Surgery | No | 2012-12-20 |
| Light, Surgical, Floor Standing | FSS | Class 2 | General, Plastic Surgery | No | 2014-09-08 |
| Table, Operating-Room, Electrical | GDC | Class 1 | General, Plastic Surgery | No | 2021-02-17 |
| Device, Medical Examination, Ac Powered | KZF | Class 1 | General Hospital | No | 2012-12-20 |
| Light, Surgical, Accessories | FTA | Class 2 | General, Plastic Surgery | No | 2025-02-10 |
Proprietary Names
Sim.LED 3500+
Sim.LED 350
Sim.CAM SD
Sim.CAM HD TOUCH
Sim.CAM HD
Sim.CAM 4K
Sim.CAM HD Wireless
Sim.CAM 4K Wireless
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
Sim.MOVE 800
Sim. LED 5000 MC
Sim. LED 7000 MC
Sim. LED 5000 SC
Sim. LED 7000 SC
Light, Surgical_Wall Mounted
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Manufacture Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)