Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3012352782

FEI Number

3012352782

Entity Name

MAGVENTURE A/S

City/State/Country

Farum Hovedstaden, DK

Establishment Address

Lucernemarken 15, Farum Hovedstaden 3520, DK

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device

Owner / Operator

MagVenture A/S (Owner Number: 10049990)

Owner / Operator Contact Address

Lucernemarken 15, Farum, DK-84 3520, DK

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K171481

PMA Number

N/A

All Registered Proprietary Names

MagVenture TMS Therapy for MDD with Comorbid Anxiety MagVenture TMS Therapy MagVita TMS Therapy MagVenture TMS Atlas Neuro Navigation System MagPro MagVita TMS Therapy MagVenture TMS Therapy MagVenture TMS Therapy MagVita TMS Therapy MagVita TMS Therapy System w/ Theta Burst Stimulation Express TMS Therapy MagVenture TMS Therapy for MDD in adolescents MagVita TMS Therapy MagVenture TMS Therapy MEP Monitor MagVita TMS Therapy - w/MagPro R20 MagVenture TMS Therapy MagPro MagVita TMS Therapy System MagPro MagVenture TMS Therapy MagVita TMS Therapy

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
QCI	Transcranial Magnetic Stimulation System For Obsessive-Compulsive Disorder	Neurology	Class 2	882.5802	2025-12-11
OBP	Transcranial Magnetic Stimulator	Neurology	Class 2	882.5805	2025-12-11
OBP	Transcranial Magnetic Stimulator	Neurology	Class 2	882.5805	2018-11-30
HAW	Neurological Stereotaxic Instrument	Neurology	Class 2	882.4560	2023-06-08
GWF	Stimulator, Electrical, Evoked Response	Neurology	Class 2	882.1870	2015-10-05
OBP	Transcranial Magnetic Stimulator	Neurology	Class 2	882.5805	2018-11-30
OBP	Transcranial Magnetic Stimulator	Neurology	Class 2	882.5805	2018-11-30
OBP	Transcranial Magnetic Stimulator	Neurology	Class 2	882.5805	2025-12-11
OBP	Transcranial Magnetic Stimulator	Neurology	Class 2	882.5805	2020-12-14
QCI	Transcranial Magnetic Stimulation System For Obsessive-Compulsive Disorder	Neurology	Class 2	882.5802	2020-12-14
GWF	Stimulator, Electrical, Evoked Response	Neurology	Class 2	882.1870	2017-04-07
OBP	Transcranial Magnetic Stimulator	Neurology	Class 2	882.5805	2019-11-06
GWF	Stimulator, Electrical, Evoked Response	Neurology	Class 2	882.1870	2026-01-06
OBP	Transcranial Magnetic Stimulator	Neurology	Class 2	882.5805	2015-10-05
GWF	Stimulator, Electrical, Evoked Response	Neurology	Class 2	882.1870	2015-10-05
OBP	Transcranial Magnetic Stimulator	Neurology	Class 2	882.5805	2018-11-30

Official Correspondent

Jan Kjoeller

US Agent Details

Kerry Rome Business: MagVenture, Inc. Email: infousa@magventure.com Phone: (888) 6247764

Related Public Records

Same Entity

MagVenture A/S

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
K243700	Mag & More GmbH	Apollo TMS Therapy System	2025-09-04
K231926	Neuronetics, Inc.	NeuroStar Advanced Therapy System (All previously cleared models)	2024-03-22
K010427	Walter Lorenz Surgical, Inc.	LORENZ FIDUCAIL SCREW	2001-03-15
K812744	Progress Mankind Technology	LEVY BIOTAC #LX001 BIOPSY PROBE HOLDER	1981-12-03
K092467	Brainlab AG	VECTORVISION CRANIAL, VECTORVISION ENT, KOLIBRI CRANIAL, KOLIBRI ENT, CRANIAL ESSENTIAL, CRANIAL UNLIMITED	2010-05-06

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0001-2012	Medtronic Navigation, Inc	2	Probe, Tactile, Left, ASM, Long, Part #962009S, Medtronic Navigation, Louisville, CO 80027. Trackable hand held instruments used in spine surgeries for preparation of the pedicle. These instruments are used in conjunction with the Medtronic Navigation StealthStation platform and various software applications.
Z-0002-2012	Medtronic Navigation, Inc	2	Probe, Tactile, Right, ASM, Long, Part #962011S, Medtronic Navigation, Louisville, CO 80027. Trackable hand held instruments used in spine surgeries for preparation of the pedicle. These instruments are used in conjunction with the Medtronic Navigation StealthStation platform and various software applications.
Z-0005-2007	Stryker Instruments Div. of Stryker Corporation	2	Stryker Navigation System, eNlite System with Dell laptop computer model D800, Stryker # 7700-300-000.
Z-0006-2007	Stryker Instruments Div. of Stryker Corporation	2	Stryker Navigation System Remote Planning Stations with Dell laptop computer model D800, Stryker # 7700-010-000 and 6000-300-000.
Z-0007-2007	Stryker Instruments Div. of Stryker Corporation	2	Stryker Navigation System Dell Model D800 laptop computers (only), Stryker # 7700-309-010 and 6000-200-064.

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3006418479	NEUROSOFT LTD	Ivanovo Ivanovskaya Oblast', RU
3014680784	Domico Med-Device, LLC	Fenton, MI, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3012352782. Last updated year: 2026. Please use registration number 3012352782 when referencing this establishment in official correspondence.