Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3006223081

FEI Number

3006223081

Entity Name

S.I.M.E.O.N. MEDICAL GMBH & Co.KG

City/State/Country

TUTTLINGEN Baden-Wurttemberg, DE

Establishment Address

In Grubenacker 18, TUTTLINGEN Baden-Wurttemberg 78532, DE

Establishment Type(s)

Manufacture Medical Device,Complaint File Establishment per 21 CFR 820.198

Owner / Operator

S.I.M.E.O.N. MEDICAL GmbH & Co. KG (Owner Number: 9093739)

Owner / Operator Contact Address

In Grubenacker 18, --, TUTTLINGEN, DE-BW 78532, DE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered 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 3500+ Sim.LED 350 Sim. LED 5000 MC Sim. LED 7000 MC Sim. LED 5000 SC Sim.LED 4500 Sim.LED 450 MC Sim. LED 7000 SC Sim.LED 700 MC Sim.LED 500 MC Sim.LED 450 SC Sim.LED 500 SC Sim.LED 700 SC Sim.LED 8000 MC Sim.LED 8000 SC

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KYT	Light, Examination, Medical, Battery Powered	General Hospital	Class 1	880.6350	2021-11-25
FSY	Light, Surgical, Ceiling Mounted	General, Plastic Surgery	Class 2	878.4580	2012-12-12
FSY	Light, Surgical, Ceiling Mounted	General, Plastic Surgery	Class 2	878.4580	2012-12-12
KQM	Camera, Surgical And Accessories	General, Plastic Surgery	Class 1	878.4160	2012-12-20
FSS	Light, Surgical, Floor Standing	General, Plastic Surgery	Class 2	878.4580	2014-09-08
GDC	Table, Operating-Room, Electrical	General, Plastic Surgery	Class 1	878.4960	2021-02-17
KZF	Device, Medical Examination, Ac Powered	General Hospital	Class 1	880.6320	2012-12-20
FSY	Light, Surgical, Ceiling Mounted	General, Plastic Surgery	Class 2	878.4580	2014-09-08

Official Correspondent

Andreas Muehlenbeck

US Agent Details

Franz Menean Business: MEDAGENT Inc. Email: mail@medagent-usa.com Phone: (603) 5702039

Related Public Records

Same Entity

S.I.M.E.O.N. MEDICAL GmbH & Co. KG

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3012165496	S.I.M.E.O.N. MEDICAL USA, LLC	Greenville, SC, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K780666	Castle Co.	DAYSTAR SELECTRA & SELECTRA/ORBITER	1978-04-27
K851742	Burton Medical Products Corp.	MEDICAL EXAMINATION LIGHTS	1985-05-13

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0028-2016	Resource Optimization & Innovation Llc	2	regard Item Number: 800091, Sterile, LD0692 - C Section - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical procedure
Z-0029-2016	Resource Optimization & Innovation Llc	2	regard Item Number: 800401, Sterile, GS0470 - Lap Pk - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical procedure
Z-0030-2016	Resource Optimization & Innovation Llc	2	regard Item Number: 800407, Sterile, OR0476 - Ortho Pk - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROI, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical procedure
Z-0031-2016	Resource Optimization & Innovation Llc	2	regard Item Number: 800408, Sterile, LD0477 - C-Section Pk - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROI, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical procedure
Z-0032-2016	Resource Optimization & Innovation Llc	2	regard Item Number: 800409, Sterile, GS0478 - LAP Chole Pk - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical procedure

Similar Registrations

Registration Number	Establishment Name	Location
3024680050	FIREFLY VEIN LIGHT LLC	Chattanooga, TN, US
3015438293	MACQUARIE MEDICAL SYSTEMS PVT. LTD	Leichhardt New South Wales, AU
3012499069	CANFIELD SCIENTIFIC, INC.	Parsippany, NJ, US
3012678246	TYTOCARE LTD.	Netanya Central, IL
1421873	XEMAX SURGICAL PRODUCTS, INC.	NAPA, CA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3006223081. Last updated year: 2026. Please use registration number 3006223081 when referencing this establishment in official correspondence.