FDA Registration
Active
🇸🇪 Sweden
LUCAS Battery, Dark Grey
Reg #: 3007275459
·
FEI: 3007275459
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- AMB INDUSTRI AB
- Registration Number
- 3007275459
- FEI Number
- 3007275459
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Kvarnvagen 26
- City
- Broakulla Kalmar
- Country
- SE
Regulatory Submissions
- 510(k) Number
- K161768
Owner / Operator
- Firm Name
- AMB Industri AB
- Operator Number
- 10054352
- Address
- Kvarnvagen 26
- City
- Broakulla
- State
- Kalmar
- Postal Code
- 36153
- Country
- SE
- Correspondent
- Maria Sundquist
US Agent
- Business Name
- Registrar Corp
- Contact Name
- David Lennarz
- Address
- 144 Research Drive
- City
- Hampton
- State
- VA
- ZIP
- 23666
- Country
- US
- [email protected]
- Phone
- 757 2240177
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Compressor, Cardiac, External | DRM | Class 2 | Cardiovascular | No | 2017-03-10 |
Proprietary Names
LUCAS Battery, Dark Grey
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)