FDA Registration
Active
🇮🇳 India
Zenition 30/718076
Reg #: 3010685285
·
FEI: 3010685285
·
Expires 2025
Products
3
Proprietary Names
1
Establishment Types
1
Classifications
3
Registration Details
- Registration Name
- Philips India Limited
- Registration Number
- 3010685285
- FEI Number
- 3010685285
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Plot no. B-79, MIDC, Phase-II, Chakan, Taluka - khed, Village - Savardari
- City
- Pune Maharashtra
- Country
- IN
Regulatory Submissions
- 510(k) Number
- K232420
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
- 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 |
|---|---|---|---|---|---|
| Interventional Fluoroscopic X-Ray System | OWB | Class 2 | Radiology | No | 2024-02-20 |
| System, X-Ray, Fluoroscopic, Image-Intensified | JAA | Class 2 | Radiology | No | 2024-02-20 |
| Image-Intensified Fluoroscopic X-Ray System, Mobile | OXO | Class 2 | Radiology | No | 2024-02-20 |
Proprietary Names
Zenition 30/718076
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)