FDA Registration
Active
🇭🇺 Hungary
MR Contour DL
Reg #: 3007120336
·
FEI: 3007120336
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- GE Healthcare Magyarorszag Kft.
- Registration Number
- 3007120336
- FEI Number
- 3007120336
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Bence utca 3
- City
- Budapest
- Country
- HU
Regulatory Submissions
- 510(k) Number
- K242925
Owner / Operator
- Firm Name
- GE HealthCare Technologies Inc.
- Operator Number
- 9912004
- Address
- 3000 N. Grandview Blvd
- City
- Waukesha
- State
- WI
- Postal Code
- 53188
- Country
- US
US Agent
- Business Name
- GE HealthCare Technologies, Inc
- Contact Name
- Tracey Holevas
- Address
- 3000 N. Grandview BLVD
- City
- Waukesha
- State
- WI
- ZIP
- 53188
- Country
- US
- [email protected]
- Phone
- 262 3092157
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Radiological Image Processing Software For Radiation Therapy | QKB | Class 2 | Radiology | No | 2025-04-15 |
Proprietary Names
MR Contour DL
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility