FDA Registration
Active
🇳🇱 Netherlands
ICX Series, INX Series
Reg #: 3006383214
·
FEI: 3006383214
·
Expires 2025
Products
1
Proprietary Names
24
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- Varex Imaging Nederland B.V.
- Registration Number
- 3006383214
- FEI Number
- 3006383214
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Fabriekstraat 41
- City
- Doetinchem Gelderland
- Country
- NL
Owner / Operator
- Firm Name
- Varex Imaging Corporation
- Operator Number
- 10053550
- Address
- 1678 South Pioneer Road
- City
- Salt Lake City
- State
- UT
- Postal Code
- 84104
- Country
- US
US Agent
- Business Name
- Varex Imaging Americas Corporation
- Contact Name
- Evangelina Garza
- Address
- 3835 Carnation St
- City
- Franklin Park
- State
- IL
- ZIP
- 60131
- Country
- US
- [email protected]
- Phone
- 847 2795100
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Generator, High-Voltage, X-Ray, Diagnostic | IZO | Class 1 | Radiology | No | 2018-12-07 |
Proprietary Names
ICX Series, INX Series
SolidStateMC 501 Series
SolidStateMC 510 Series
SolidStateMC 601 Series
SolidStateMC 613 Series
SolidStateMC 619 Series
SolidStateMC 609 Series
SolidStateMC 502 Series
AmpMC 1002 Series
AmpMC 1006 Series
AmpMC 1008 Series
SolidStateMC 508 Series
SolidStateMC 506 Series
SolidStateMC 625 Series
SolidStateMC 621 Series
AmpMC 1012 Series
SolidStateMC 610 Series
SolidStateMC 614 Series
AmpMC 1007 Series
SolidStateMC 616 Series
AmpMC 1001 Series
SolidStateMC 617 Series
SolidStateMC 521 Series
SolidStateMC 605 Series
Establishment Types
Manufacture Medical Device
Complaint File Establishment per 21 CFR 820.198