FDA Registration
Active
🇳🇴 Norway
HOLBERG EEG AS
Reg #: 3030646118
·
FEI: 3030646118
·
Expires 2026
Products
1
Proprietary Names
2
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- HOLBERG EEG AS
- Registration Number
- 3030646118
- FEI Number
- 3030646118
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Fjosangerveien 70 A, 5068 Bergen
- City
- Bergen Hordaland
- Country
- NO
Regulatory Submissions
- 510(k) Number
- K243743
Owner / Operator
- Firm Name
- Holberg EEG AS
- Operator Number
- 10090411
- Address
- Fjosangerveien 70 A, 5068 Bergen
- City
- Bergen
- State
- NO-NOTA
- Postal Code
- 5068
- Country
- NO
- Correspondent
- Smriti Franklin
US Agent
- Business Name
- Natus Neuro
- Contact Name
- Courtney Walton
- Address
- 3610 County Road 101 South
- City
- Deephaven
- State
- MN
- ZIP
- 55391
- Country
- US
- [email protected]
- Phone
- 651 4215870
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Automatic Event Detection Software For Full-Montage Electroencephalograph | OMB | Class 2 | Neurology | No | 2025-06-17 |
Proprietary Names
autoSCORE (V 2)
autoSCORE
Establishment Types
Manufacture Medical Device