FDA Registration
Active
🇧🇪 Belgium
HP PRO Positioning Device
Reg #: 9613183
·
FEI: 1000227792
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- ORFIT INDUSTRIES NV
- Registration Number
- 9613183
- FEI Number
- 1000227792
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 9A, VOSVELD
- City
- WIJNEGEM Antwerpen
- Country
- BE
Regulatory Submissions
- 510(k) Number
- K171734
Owner / Operator
- Firm Name
- ORFIT INDUSTRIES NV
- Operator Number
- 9015000
- Address
- VOSVELD 9A, --
- City
- WIJNEGEM
- State
- BE-NOTA
- Postal Code
- 2110
- Country
- BE
US Agent
- Business Name
- Medes USA C/O Matan Arazy
- Contact Name
- Benny Arazy
- Address
- 15201 6th Ave NE, ,
- City
- Shoreline
- State
- WA
- ZIP
- 98155
- Country
- US
- [email protected]
- Phone
- 415 9921126
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Accelerator, Linear, Medical | IYE | Class 2 | Radiology | No | 2018-01-02 |
Proprietary Names
HP PRO Positioning Device
Establishment Types
Manufacture Medical Device