FDA Registration
Active
🇵🇭 Philippines
HypeByte; SureSmile VPRO
Reg #: 3013423303
·
FEI: 3013423303
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- KAERTECH ELECTRONICS PHILIPPINES INC
- Registration Number
- 3013423303
- FEI Number
- 3013423303
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Building 3, EZP Compound, Laguna Technopark Annex
- City
- Binan Laguna
- Country
- PH
Regulatory Submissions
- 510(k) Number
- K183018
Owner / Operator
- Firm Name
- Kaertech Limited
- Operator Number
- 10052737
- Address
- Unit 15 6/F, Hong Kong Plaza, 188 Connaught Road West
- City
- Kennedy Town
- State
- HK-NOTA
- Postal Code
- 000
- Country
- HK
- Correspondent
- Marjorie L Cuevas
US Agent
- Business Name
- Kaertech Inc
- Contact Name
- Mathew John
- Address
- 295 Madison Ave., Suite 1130
- City
- New York
- State
- NY
- ZIP
- 10017
- Country
- US
- [email protected]
- Phone
- 212 9830890 ext. 201
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Orthodontic Vibratory Accessory | OYH | Class 2 | Dental | No | 2023-10-26 |
Proprietary Names
HypeByte; SureSmile VPRO
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)