FDA Registration
Active
🇹🇼 Taiwan
VISGENEER, INC.
Reg #: 3005644014
·
FEI: 3005644014
·
Expires 2026
Products
7
Proprietary Names
12
Establishment Types
3
Classifications
7
Registration Details
- Registration Name
- VISGENEER, INC.
- Registration Number
- 3005644014
- FEI Number
- 3005644014
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- NO. 335, SEC. 6, Zhonghua ROAD
- City
- HSINCHU CITY Hsinchu (City)
- Country
- TW
Regulatory Submissions
- 510(k) Number
- K062555
Owner / Operator
- Firm Name
- VISGENEER, INC.
- Operator Number
- 9084502
- Address
- NO. 335, SEC. 6, Zhunghua ROAD
- City
- HSINCHU CITY
- State
- TW-NOTA
- Postal Code
- 30094
- Country
- TW
- Correspondent
- Ken-Shwo - Dai
US Agent
- Business Name
- Pragmatic Compliance dba FDAbasics
- Contact Name
- Emily Matorin
- Address
- 1 Prospect Park W Apt 4d
- City
- Brooklyn
- State
- NY
- ZIP
- 11215
- Country
- US
- [email protected]
- Phone
- 716 7750533
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| System, Test, Blood Glucose, Over The Counter | NBW | Class 2 | Clinical Chemistry | No | 2007-02-02 |
| Single (Specified) Analyte Controls (Assayed And Unassayed) | JJX | Class 1 | Clinical Chemistry | No | 2007-02-02 |
| Glucose Oxidase, Glucose | CGA | Class 2 | Clinical Chemistry | No | 2007-02-02 |
| Enzymatic Esterase--Oxidase, Cholesterol | CHH | Class 1 | Clinical Chemistry | No | 2021-07-13 |
| Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature | QRK | Class 2 | General, Plastic Surgery | No | 2022-11-08 |
| Multiple Use Blood Lancet For Single Patient Use Only | QRL | Class 2 | General, Plastic Surgery | No | 2022-11-08 |
| Nitroprusside, Ketones (Urinary, Non-Quant.) | JIN | Class 1 | Clinical Chemistry | No | 2018-09-07 |
Proprietary Names
eBsensor
eBsugar
eB-Tchol
eBmonitor eBchek
eBchek
eBcarryon
eBketone blood ketone test strip
eBketolife blood ketone test strip
eBketone blood ketone meter
eBketone blood ketone monitoring system
eBketolife blood ketone meter
eBketolife blood ketone monitoring system
Establishment Types
Manufacture Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)
Repack or Relabel Medical Device