FDA Registration
Active
🇸🇬 Singapore
186-0160 BIS Extend Sensor
Reg #: 3008202779
·
FEI: 3008202779
·
Expires 2025
Products
1
Proprietary Names
8
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- CELESTICA ELECTRONICS (S) PTE LTD.
- Registration Number
- 3008202779
- FEI Number
- 3008202779
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 6 Serangoon North Avenue 5, #05-03/04, #05-06/07/08
- City
- Singapore Central Singapore
- Country
- SG
Regulatory Submissions
- 510(k) Number
- K143506
Owner / Operator
- Firm Name
- Celestica Electronics (S) Pte Ltd.
- Operator Number
- 10037016
- Address
- 6 Serangoon North Avenue 5 #06-11
- City
- Singapore
- State
- Central Singapore
- Postal Code
- 554910
- Country
- SG
- Correspondent
- Chee Keong Yee
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Electrode, Cutaneous | GXY | Class 2 | Neurology | No | 2016-08-16 |
Proprietary Names
186-0160 BIS Extend Sensor
186-0106-PH Case, Sensor, Quatro, Philips
186-0106 BIS Quatro Sensor
186-0212 BIS Bilateral Sensor
186-0150-PH BIS Quatro Sensor Starter Kit, Philips
186-0150 Quatro Sensor Starter Kit
186-0212-PH Philips Bilateral Sensor Kit
186-0200 BIS Pediatric-XP Sensor
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)