Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3012460907

FEI Number

3012460907

Entity Name

MED CONTACT GMBH

City/State/Country

Burladingen-Salmendingen Baden-Wurttemberg, DE

Establishment Address

Kornbuehlstrasse 100-102, Burladingen-Salmendingen Baden-Wurttemberg 72393, DE

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

Med Contact GmbH (Owner Number: 10050456)

Owner / Operator Contact Address

Kornbuehlstrasse 100-102, Burladingen-Salmendingen, DE-BW 72393, DE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K100275

PMA Number

N/A

All Registered Proprietary Names

No proprietary names listed under this establishment.

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2018-02-13
HET	Laparoscope, Gynecologic (And Accessories)	Obstetrics/Gynecology	Class 2	884.1720	2015-11-19
GCP	Endoscope, Ac-Powered And Accessories	Gastroenterology, Urology	Class 2	876.1500	2015-11-19
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2015-11-19
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2015-11-19
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2015-11-19
FAS	Electrode, Electrosurgical, Active, Urological	Gastroenterology, Urology	Class 2	876.4300	2015-11-19

Official Correspondent

Michael Stier

US Agent Details

Kenneth Kleinhenz Business: QSR Consulting Email: kleinhenz64@gmail.com Phone: (619) 2449573

Related Public Records

Same Entity

Med Contact GmbH

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

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K970809	Somnus Medical Technologies, Inc.	BENDABLE TISSUE COAGULATING ELECTRODE WITH BENDING TOOL	1997-06-18
K222793	C.R. Bard, Inc.	WavelinQ Generator	2022-10-17
K002257	Tecno Instruments (Pvt.) , Ltd.	TECNO DISPOSABLE FINGERSWITCH PENCIL, MODEL 150-100	2000-10-19
K193591	Bowa-Electronics GmbH & Co. KG	ARC 400	2020-04-02
K192128	Sutter Medizintechnik GmbH	Sutter Arrowtip Monopolar Electrodes	2019-10-04

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0031-06	Rita Medical Systems	2	Rita Brand Habib 4X Electrosurgical Coagulator, Catalog Number: 4401US; Product is distributed by RITA Medical Systems, Inc., One Horizon Way. Manchester, GA 32826
Z-0023-2009	Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa	2	Applied Medical, Separator Abdominal Access System REF: C0604 15 x 100mm Non-threaded Separator System with Universal Seal, for laparoscopic procedures.
Z-0024-2009	Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa	2	Applied Medical, Separator Abdominal Access System REF:C0605 15x100mm Threaded Separator System with Universal Seal, for laparoscopic procedures.
Z-0025-2009	Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa	2	Applied Medical, Separator Abdominal Access System REF: C0606 15x150mm Non-threaded Separator System with Universal Seal, for laparoscopic procedures.
Z-0026-2009	Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa	2	Applied Medical, Separator Abdominal Access System REF: C0607 15x150mm Threaded Separator System with Universal Seal, for laparoscopic procedures.

Similar Registrations

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3012616488	BRERA MEDICAL INCORPORATED	Northborough, MA, US
3012940012	Sutter Medical Technologies USA Inc.	Alpharetta, GA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3012460907. Last updated year: 2026. Please use registration number 3012460907 when referencing this establishment in official correspondence.