FDA Registration Active 🇩🇰 Denmark

TONICA ELEKTRONIK A/S

Reg #: 3005545216 · FEI: 3005545216 · Expires 2026
Products
6
Proprietary Names
18
Establishment Types
2
Classifications
6

Registration Details

Registration Name
TONICA ELEKTRONIK A/S
Registration Number
3005545216
FEI Number
3005545216
Status
Active
Expiry Year
2026
Initial Importer
No
Address
LUCERNEMARKEN 15
City
FARUM Hovedstaden
Country
DK

Regulatory Submissions

510(k) Number
K926516

Owner / Operator

Firm Name
TONICA ELEKTRONIK A/S
Operator Number
9081660
Address
LUCERNEMARKEN 15, --
City
FARUM
State
DK-NOTA
Postal Code
3520
Country
DK
Correspondent
JAN - KJOELLER

US Agent

Business Name
MagVenture, Inc.
Contact Name
Kerry Rome
Address
1525 Bluegrass LakesParkway, Suite B
City
Alpharetta
State
GA
ZIP
30004
Country
US
Phone
888 6247764

Products

Device Name Product Code
Stimulator, Electrical, Evoked Response GWF
Transcranial Magnetic Stimulator OBP
Transcranial Magnetic Stimulation System For Obsessive-Compulsive Disorder QCI
Neurological Stereotaxic Instrument HAW
Electromagnetic Stimulator, Pain Relief QPL
Stimulator, Muscle, Powered IPF

Proprietary Names

MAGLITE MAGNETIC STIMULATOR MAGPRO MAGNETIC STIMULATOR MagPro Magnetic Stimulator MagVita TMS Therapy MagVenture TMS Therapy MagVita TMS Therapy System Coil for MagPro MagVenture TMS Therapy for MDD with Comorbid Anxiety SAINT neuromodulation system MagPro R20 Express TMS Xpress TMS MagVita TMS Therapy System w/ Theta Burst Stimulation Express TMS Therapy MagVita TMS Therapy - w/MagPro R20 Coil T65 MEP Monitor MagVenture TMS Atlas Neuro Navigation System

Establishment Types

Manufacture Medical Device Manufacture Medical Device for Another Party (Contract Manufacturer)