FDA Registration
Active
🇳🇱 Netherlands
MASENA INVEST, BV
Reg #: 3012312061
·
FEI: 3012312061
·
Expires 2026
Products
7
Proprietary Names
3
Establishment Types
1
Classifications
7
Registration Details
- Registration Name
- MASENA INVEST, BV
- Registration Number
- 3012312061
- FEI Number
- 3012312061
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Burgemeester de Raadtsingel 71
- City
- Dordrecht Zuid-Holland
- Country
- NL
Regulatory Submissions
- 510(k) Number
- K092447
Owner / Operator
- Firm Name
- Masena Invest, BV
- Operator Number
- 10052668
- Address
- Burgemeester de Raadtsingel 71
- City
- Dordrecht
- State
- NL-NOTA
- Postal Code
- 3311 JG
- Country
- NL
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 |
|---|---|---|---|---|---|
| Continuous Measurement Thermometer | FLL | Class 2 | General Hospital | No | 2019-01-04 |
| System, Measurement, Blood-Pressure, Non-Invasive | DXN | Class 2 | Cardiovascular | No | 2018-01-03 |
| Oximeter | DQA | Class 2 | Cardiovascular | No | 2018-04-17 |
| Kit, Test, Pregnancy, Hcg, Over The Counter | LCX | Class 2 | Clinical Chemistry | No | 2018-04-17 |
| Visual, Pregnancy Hcg, Prescription Use | JHI | Class 2 | Clinical Chemistry | No | 2019-08-09 |
| Thermometer, Clinical Mercury | FLK | Class 2 | General Hospital | No | 2016-09-06 |
| Test, Luteinizing Hormone (Lh), Over The Counter | NGE | Class 1 | Clinical Chemistry | No | 2017-09-11 |
Proprietary Names
iProven NCT- 336BLUE
NCT-336BLACK
FK-127-co
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility