FDA Registration
Active
🇹🇼 Taiwan
THE EDGE
Reg #: 9616936
·
FEI: 3002671736
·
Expires 2025
Products
1
Proprietary Names
6
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- APEX BIOTECHNOLOGY CORP.
- Registration Number
- 9616936
- FEI Number
- 3002671736
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- NO. 7, LI-HSIN ROAD V,, HSINCHU SCIENCE PARK
- City
- HSINCHU
- Country
- TW
Owner / Operator
- Firm Name
- APEX BIOTECHNOLOGY CORP.
- Operator Number
- 9034629
- Address
- NO. 7, LI-HSIN ROAD V,, HSINCHU SCIENCE PARK
- City
- HSINCHU
- State
- TW-NOTA
- Postal Code
- 30078
- Country
- TW
US Agent
- Business Name
- ARKRAY Factory USA, Inc.
- Contact Name
- Tom Speikers
- Address
- 8260 NW 27th Street, Suite 403
- City
- Miami
- State
- FL
- ZIP
- 33122
- Country
- US
- [email protected]
- Phone
- 952 6463168
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Single (Specified) Analyte Controls (Assayed And Unassayed) | JJX | Class 1 | Clinical Chemistry | No | 2017-06-28 |
Proprietary Names
THE EDGE
Pip glucose control solution V1
KETONECOACH
Embrace WAVE glucose control solution
Microlife SmartBG glucose control solution
UASure II uric acid control solution
Establishment Types
Manufacture Medical Device