FDA Registration
Active
🇹🇼 Taiwan
TST BIOMEDICAL ELECTRONICS CO., LTD.
Reg #: 3023197868
·
FEI: 3023197868
·
Expires 2026
Products
7
Proprietary Names
11
Establishment Types
2
Classifications
7
Registration Details
- Registration Name
- TST BIOMEDICAL ELECTRONICS CO., LTD.
- Registration Number
- 3023197868
- FEI Number
- 3023197868
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 2F, No. 3, Industrial 2nd Rd., Pingzhen Dis., Taoyuan City, Taiwan
- City
- Taoyuan
- Country
- TW
Owner / Operator
- Firm Name
- tst Biomedical Electronics Co., Ltd.
- Operator Number
- 10087980
- Address
- 2F, No. 3, Industrial 2nd Rd., Pingzhen Dis., Taoyuan City, Taiwan
- City
- Taoyuan
- State
- TW-TAO
- Postal Code
- 324
- Country
- TW
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl | LBS | Class 1 | Clinical Chemistry | No | 2023-07-20 |
| Enzymatic Esterase--Oxidase, Cholesterol | CHH | Class 1 | Clinical Chemistry | No | 2023-07-20 |
| Apolipoproteins | MSJ | Class 1 | Clinical Chemistry | No | 2023-05-26 |
| Albumin, Antigen, Antiserum, Control | DCF | Class 2 | Immunology | No | 2023-07-20 |
| System, Test, Lipoprotein(A) | MSM | Class 1 | Clinical Chemistry | No | 2023-05-26 |
| Analyzer, Chemistry, Micro, For Clinical Use | JJF | Class 1 | Clinical Chemistry | No | 2023-05-26 |
| Analyzer, Chemistry, Centrifugal, For Clinical Use | JJG | Class 1 | Clinical Chemistry | No | 2023-07-20 |
Proprietary Names
iPro-Lab HDL Cholesterol Kit
iPro-Lab Lipid Panel
iProtin ApoA1 Assay Cartridge Kit
iProtin ApoB Assay Cartridge Kit
iProtin Albumin Assay Cartridge Kit
iProtin Microalbumin Assay Cartridge Kit
iPro-Lab Microalbumin(mALB) Test
iProtin Lp(a) Assay Cartridge Kit
iProtin Reader
iProtin Reader (BT ver.)
iPro-Lab Clinical Chemistry Analyzer
Establishment Types
Export Device to the United States But Perform No Other Operation on Device
Develop Specifications But Do Not Manufacture At This Facility