FDA Registration
Active
🇹🇼 Taiwan
WISTRON MEDICAL TECHNOLOGY CORPORATION
Reg #: 3008460104
·
FEI: 3008460104
·
Expires 2026
Products
3
Proprietary Names
11
Establishment Types
1
Classifications
3
Registration Details
- Registration Name
- WISTRON MEDICAL TECHNOLOGY CORPORATION
- Registration Number
- 3008460104
- FEI Number
- 3008460104
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 4F-1, 4F-2, 4F-3, 4F-5, 4F-6, No. 150, Sec. 2, Shengyi Rd.
- City
- Zhubei City Hsinchu
- Country
- TW
Owner / Operator
- Firm Name
- Wistron Medical Technology Corporation
- Operator Number
- 10056677
- Address
- 4F-1, 4F-2, 4F-3, 4F-5, 4F-6, No. 150, Sec. 2, Shengyi Rd.
- City
- Zhubei City
- State
- Hsinchu
- Postal Code
- 302058
- Country
- TW
- Correspondent
- Peggy Tsai
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Transmitters And Receivers, Physiological Signal, Radiofrequency | DRG | Class 2 | Cardiovascular | No | 2024-11-05 |
| Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) | DRT | Class 2 | Cardiovascular | No | 2024-11-05 |
| Calculator, Drug Dose | NDC | Class 2 | Anesthesiology | No | 2022-12-22 |
Proprietary Names
BioButton System (Multi-patient Use or MPU)
BioButton Rechargeable (BBR)
BioButton Rechargeable
BioButton MPU
BioButton v3
BioButton Charging Station
BioButton remote patient monitoring device
BioButton wearable device
BioButton Rechargeable
BioButton
BioButton wearable sensor
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)