Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3007427881

FEI Number

3007427881

Entity Name

MEDIKOMP GMBH

City/State/Country

Rastatt Baden-Wurttemberg, DE

Establishment Address

Kehler Strasse 31, Rastatt Baden-Wurttemberg 76437, DE

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

MediKomp GmbH (Owner Number: 10031001)

Owner / Operator Contact Address

KEHLER STRASSE 31, Rastatt, DE-BW 76437, DE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

ROTAFLOW Emergency Drive ROTAFLOW Console ROTAFLOW Drive Unit Heart Lung Machine HL-20 Twin Pump Heart Lung Machine HL-20 CARDIOHELP-I, CARDIOHELP Emergency Drive, Accessories

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KFM	Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type	Cardiovascular	Class 2	870.4360	2012-08-22
DPW	Flowmeter, Blood, Cardiovascular	Cardiovascular	Class 2	870.2100	2012-08-22
DTQ	Console, Heart-Lung Machine, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4220	2012-08-22
DTQ	Console, Heart-Lung Machine, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4220	2022-04-25

Official Correspondent

Tom Peters

US Agent Details

Emily Valerio Email: emily.valerio@getinge.com Phone: (862) 2215193

Related Public Records

Same Entity

MediKomp 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
K903633	Transonic Systems, Inc.	ADVANCE LASER FLOWMETER, ALF 21	1990-10-09
K182494	Laser Associated Sciences, Inc.	FlowMet-R	2019-02-27

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3007427881. Last updated year: 2026. Please use registration number 3007427881 when referencing this establishment in official correspondence.