FDA Registration
Active
🇳🇱 Netherlands
DEMCON PRODUCTION B.V.
Reg #: 3011790297
·
FEI: 3011790297
·
Expires 2026
Products
11
Proprietary Names
16
Establishment Types
1
Classifications
11
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Registration Details
- Registration Name
- DEMCON PRODUCTION B.V.
- Registration Number
- 3011790297
- FEI Number
- 3011790297
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Institutenweg 50
- City
- Enschede Overijssel
- Country
- NL
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 |
|---|---|---|---|---|---|
| System, Gastrointestinal Motility (Electrical) | FFX | Class 2 | Gastroenterology, Urology | No | 2024-09-19 |
| System, Image Processing, Radiological | LLZ | Class 2 | Radiology | No | 2019-05-27 |
| Device, Cystometric, Hydraulic | FEN | Class 2 | Gastroenterology, Urology | No | 2019-05-27 |
| Plethysmograph, Impedance | DSB | Class 2 | Cardiovascular | No | 2018-11-29 |
| Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) | DRT | Class 2 | Cardiovascular | No | 2018-11-29 |
| Oximeter | DQA | Class 2 | Cardiovascular | No | 2018-11-29 |
| System, Measurement, Blood-Pressure, Non-Invasive | DXN | Class 2 | Cardiovascular | No | 2018-11-29 |
| Cystometer, Electrical Recording | EXQ | Class 2 | Gastroenterology, Urology | No | 2019-05-27 |
| Device, Nerve Conduction Velocity Measurement | JXE | Class 2 | Neurology | No | 2019-05-27 |
| Stimulator, Electrical, Evoked Response | GWF | Class 2 | Neurology | No | 2019-05-27 |
| Humidifier, Respiratory Gas, (Direct Patient Interface) | BTT | Class 2 | Anesthesiology | No | 2015-12-14 |
Proprietary Names
Solar Compact
Solar GI with MMS Video option, network and DICOM (VID410, VID625)
Solar GI (G3-x)
Solar GI with MPP Plus
Nexam with MPP Plus
Solar GI with CIM-AUX (G3-9, G3-10, G3-15)
Ohmega (G2-x)
Solar Blue (U3-x)
Luna (U5-1)
Nexam (U8-x)
Finapres NOVA NanoCore
Flowmaster (U1-1)
Flowstar (U2-1)
Finapres NOVA Hemodynamic CNIBPM
Solar GI with Neuro Module
Medisize Gold Heater
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)