FDA Registration
Active
🇳🇴 Norway
NeoBeat, NeoBeat Mini
Reg #: 3031563234
·
FEI: 3031563234
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Laerdal Medical AS, Stavanger Manufacturing
- Registration Number
- 3031563234
- FEI Number
- 3031563234
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Vestre Svanholmen 3
- City
- Sandnes Rogaland
- Country
- NO
Regulatory Submissions
- 510(k) Number
- K232111
Owner / Operator
- Firm Name
- LAERDAL MEDICAL A/S
- Operator Number
- 9038993
- Address
- Tanke Svilandsgate 30, --
- City
- Stavanger
- State
- Rogaland
- Postal Code
- 4007
- Country
- NO
US Agent
- Business Name
- Laerdal Medical Corporation
- Contact Name
- Gina Beshai
- Address
- 167 MYERS CORNERS RD., --
- City
- Wappingers Falls
- State
- NY
- ZIP
- 12590
- Country
- US
- [email protected]
- Phone
- 845 6853187
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) | MWI | Class 2 | Cardiovascular | No | 2024-09-05 |
Proprietary Names
NeoBeat, NeoBeat Mini
Establishment Types
Manufacture Medical Device