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Medcom GMBH: FDA-registered device maker in Darmstadt Hesse, Germany, 5 510(k) clearances

Name: Medcom GMBH FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Medcom GMBH is registered with the FDA (registration 3006579682) in Darmstadt Hesse, Germany. It lists 5 device types. The FDA files 5 510(k) clearances under its listings, the newest dated September 21, 2018. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3006579682
Address: Dolivostrasse 11, Darmstadt Hesse, Germany, 64293
Owner or operator: MedCom GmbH (10029901)
Roles: Manufacturer
First device listed: April 8, 2014
Registered through: 2026
Brand names listed: BiopSee, BiopSee, Mobile US, Mobile US, NaviSuite, NaviSuite SSI Edition, Prelude, VERISUITE, VERISUITE-PARTICLE and more

Devices it lists

Device	Product code	Class	Role	Source
Accelerator, Linear, Medical	IYE	2	Manufacturer	accessdata.fda.gov
Instrument, Quality-Assurance, Radiologic	LHO	1	Manufacturer	accessdata.fda.gov
System, Image Processing, Radiological	LLZ	2	Manufacturer	accessdata.fda.gov
System, Planning, Radiation Therapy Treatment	MUJ	2	Manufacturer	accessdata.fda.gov
System, Radiation Therapy, Charged-Particle, Medical	LHN	2	Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
September 21, 2018	K181789	VeriSuite	LHN	Substantially Equivalent	Medcom GmbH	accessdata.fda.gov
March 27, 2018	K180308	Prelude	MUJ	Substantially Equivalent	Medcom GmbH	accessdata.fda.gov
July 26, 2017	K170841	BiopSee, Mobile US	LLZ	Substantially Equivalent	Medcom GmbH	accessdata.fda.gov
May 1, 2017	K163119	NaviSuite SSI Edition	LLZ	Substantially Equivalent	Medcom GmbH	accessdata.fda.gov
April 3, 2014	K133914	VERISUITE 1.8, VERISUITE-PARTICLE 1.8, VERISUITE, VERISUITE-PARTICLE	LHN	Substantially Equivalent	Medcom GmbH	accessdata.fda.gov

Compare with other makers

Updated September 21, 2018. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.