FDA Registration
Active
🇭🇷 Croatia
EEG ELECTRODE
Reg #: 3021192567
·
FEI: 3021192567
·
Expires 2025
Products
1
Proprietary Names
3
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- PAMEL D.O.O.
- Registration Number
- 3021192567
- FEI Number
- 3021192567
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Dubravica 41f
- City
- Zagreb Zagreb, Grad
- Country
- HR
Regulatory Submissions
- 510(k) Number
- K211315
Owner / Operator
- Firm Name
- Pamel d.o.o.
- Operator Number
- 10083725
- Address
- Dubravica 41f
- City
- Zagreb
- State
- Zagreb, Grad
- Postal Code
- 10090
- Country
- HR
- Correspondent
- Marko Pavic
US Agent
- Business Name
- BEE Systems, Inc
- Contact Name
- Bernhard Wandernoth
- Address
- 7724 SW Nimbus Ave, Bldg 10 S
- City
- Beaverton
- State
- OR
- ZIP
- 97008
- Country
- US
- [email protected]
- Phone
- 818 6481773
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Electrode, Cutaneous | GXY | Class 2 | Neurology | No | 2021-12-14 |
Proprietary Names
EEG ELECTRODE
COMBY EEG CAP ACCESSORIE
COMBY EEG CAP
Establishment Types
Manufacture Medical Device