FDA Registration
Active
🇲🇽 Mexico
HELIOS Collimator
Reg #: 9616047
·
FEI: 3003377038
·
Expires 2025
Products
1
Proprietary Names
6
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- GE MEDICAL SYSTEMS MONTERREY MEXICO, S.A. DE C.V.
- Registration Number
- 9616047
- FEI Number
- 3003377038
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- CALLE ESPANA No. 300, PARQUE INDUSTRIAL HUINALA
- City
- APODACA Nuevo Leon
- Country
- MX
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 |
|---|---|---|---|---|---|
| Collimator, Automatic, Radiographic | IZW | Class 2 | Radiology | No | 2014-12-02 |
Proprietary Names
HELIOS Collimator
X-Ray Collimator
Lunar iDXA series Collimator Assembly
Prodigy/DPX Series Collimator Assembly
Brivo OEC Beam Limiting Device
Wolverine Collimator
Establishment Types
Manufacture Medical Device