FDA Registration
Active
🇮🇳 India
CombiDiagnost R90
Reg #: 3033527770
·
FEI: 3033527770
·
Expires 2025
Products
3
Proprietary Names
1
Establishment Types
1
Classifications
3
Registration Details
- Registration Name
- Philips India Limited - Diagnostic X-ray Business Unit
- Registration Number
- 3033527770
- FEI Number
- 3033527770
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Philips Innovation Campus, Embassy Business Hub, Venkatala Village, Yelahanka Hobli, Yelahanka
- City
- Bengaluru Karnataka
- Country
- IN
Regulatory Submissions
- 510(k) Number
- K163210
Owner / Operator
- Firm Name
- Philips Medical Systems International BV
- Operator Number
- 1217116
- Address
- Veenpluis 6
- City
- Best
- State
- NL-NOTA
- Postal Code
- 5684PC
- Country
- NL
US Agent
- Business Name
- PHILIPS MEDICAL SYSTEMS INTERNATIONAL BV
- Contact Name
- Maria Heiling
- Address
- 3721 Valley Centre Dr., Ste. 500
- City
- San Diego
- State
- CA
- ZIP
- 92130
- Country
- US
- [email protected]
- Phone
- 858 2487651
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| System, X-Ray, Fluoroscopic, Image-Intensified | JAA | Class 2 | Radiology | No | 2017-02-10 |
| System, X-Ray, Stationary | KPR | Class 2 | Radiology | No | 2017-02-10 |
| Solid State X-Ray Imager (Flat Panel/Digital Imager) | MQB | Class 2 | Radiology | No | 2017-02-10 |
Proprietary Names
CombiDiagnost R90
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility