FDA Registration
Active
🇮🇩 Indonesia
Disposable EEG Cup Electrode
Reg #: 3008892509
·
FEI: 3008892509
·
Expires 2025
Products
1
Proprietary Names
14
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- TECHNOMED ASIA, PT.
- Registration Number
- 3008892509
- FEI Number
- 3008892509
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- K.I. Trikencana Kav. 4-5, Jl. Kopo Katapang km 11
- City
- Bandung Jawa Barat
- Country
- ID
Regulatory Submissions
- 510(k) Number
- K072016
Owner / Operator
- Firm Name
- Technomed Europe
- Operator Number
- 9036062
- Address
- Wiebachstraat 25a
- City
- Kerkrade
- State
- Limburg
- Postal Code
- 6466NG
- Country
- NL
US Agent
- Business Name
- Technomed USA, Inc.
- Contact Name
- Jennifer Maahs
- Address
- 1626 Terrace Dr., Roseville
- City
- Minneapolis
- State
- MN
- ZIP
- 55413
- Country
- US
- [email protected]
- Phone
- 651 2880890
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Electrode, Cutaneous | GXY | Class 2 | Neurology | No | 2008-01-02 |
Proprietary Names
Disposable EEG Cup Electrode
Reusable Ear Clip Electrode
Reusable EEG Cup Electrode Au plated
Disposable EEG Cup+ Electrode
Disposable EEG Cup Electrode Ag/AgCl coated
Disposable EEG XS Cup Electrode
Reusable EEG Cup Electrode
Disposable EEG XS Cup Electrode Ag/Agcl coated
Reusable EEG Cup Electrode Ag plated
Reusable Ear clip Electrode Ag plated
Reusable EEG Cup Electrode Ag/AgCl coated
Disposable EEG Cup+ Electrode Ag/AgCl coated
Reusable Ear clip Electrode Ag/AgCl coated
Reusable Ear clip Electrode Au plated
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)