FDA Registration
Active
🇳🇱 Netherlands
BV Pulsera
Reg #: 3003768277
·
FEI: 3002807880
·
Expires 2025
Products
3
Proprietary Names
2
Establishment Types
1
Classifications
3
Registration Details
- Registration Name
- PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
- Registration Number
- 3003768277
- FEI Number
- 3002807880
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- VEENPLUIS 6
- City
- BEST Noord-Brabant
- Country
- NL
Regulatory Submissions
- 510(k) Number
- K010435
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 |
|---|---|---|---|---|---|
| System, X-Ray, Fluoroscopic, Image-Intensified | JAA | Class 2 | Radiology | No | 2006-02-21 |
| Interventional Fluoroscopic X-Ray System | OWB | Class 2 | Radiology | No | 2006-02-21 |
| Image-Intensified Fluoroscopic X-Ray System, Mobile | OXO | Class 2 | Radiology | No | 2006-02-21 |
Proprietary Names
BV Pulsera
BV Endura
Establishment Types
Manufacture Medical Device