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
- [email protected]
- Phone
- 888 6247764
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Stimulator, Electrical, Evoked Response | GWF | Class 2 | Neurology | No | 2006-01-11 |
| Transcranial Magnetic Stimulator | OBP | Class 2 | Neurology | No | 2018-11-06 |
| Transcranial Magnetic Stimulation System For Obsessive-Compulsive Disorder | QCI | Class 2 | Neurology | No | 2025-11-26 |
| Neurological Stereotaxic Instrument | HAW | Class 2 | Neurology | No | 2024-02-23 |
| Electromagnetic Stimulator, Pain Relief | QPL | Class 2 | Neurology | No | 2023-09-15 |
| Stimulator, Muscle, Powered | IPF | Class 2 | Physical Medicine | No | 2023-09-15 |
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)