FDA Registration
Active
🇳🇱 Netherlands
Finapres NOVA NanoCore
Reg #: 3011790297
·
FEI: 3011790297
·
Expires 2025
Products
4
Proprietary Names
1
Establishment Types
1
Classifications
4
Registration Details
- Registration Name
- DEMCON PRODUCTION B.V.
- Registration Number
- 3011790297
- FEI Number
- 3011790297
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Institutenweg 50
- City
- Enschede Overijssel
- Country
- NL
Regulatory Submissions
- 510(k) Number
- K173916
Owner / Operator
- Firm Name
- Demcon Production B.V.
- Operator Number
- 10049517
- Address
- Institutenweg 50
- City
- Enschede
- State
- Overijssel
- Postal Code
- 7521 PK
- Country
- NL
US Agent
- Business Name
- ADINSTRUMENTS, INC.
- Contact Name
- Marissa Theorin
- Address
- 4360 Arrowswest Dr
- City
- Colorado Springs
- State
- CO
- ZIP
- 80907
- Country
- US
- [email protected]
- Phone
- 719 3060305
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Plethysmograph, Impedance | DSB | Class 2 | Cardiovascular | No | 2018-11-29 |
| Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) | DRT | Class 2 | Cardiovascular | No | 2018-11-29 |
| System, Measurement, Blood-Pressure, Non-Invasive | DXN | Class 2 | Cardiovascular | No | 2018-11-29 |
| Oximeter | DQA | Class 2 | Cardiovascular | No | 2018-11-29 |
Proprietary Names
Finapres NOVA NanoCore
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)