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
Phone
603 5702039

Products

Device Name Product Code
Light, Examination, Medical, Battery Powered KYT
Light, Surgical, Ceiling Mounted FSY
Camera, Surgical And Accessories KQM
Light, Surgical, Floor Standing FSS
Table, Operating-Room, Electrical GDC
Device, Medical Examination, Ac Powered KZF
Light, Surgical, Accessories FTA

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)