FDA Registration Active 🇹🇼 Taiwan

GE Blood Glucose Monitoring System 180

Reg #: 3004183148 · FEI: 3004183148 · Expires 2025
Products
1
Proprietary Names
9
Establishment Types
1
Classifications
1

Registration Details

Registration Name
BIONIME CORPORATION
Registration Number
3004183148
FEI Number
3004183148
Status
Active
Expiry Year
2025
Initial Importer
No
Address
NO. 100, Sec. 2, Daqing St., South Dist.
City
Taichung City
Country
TW

Regulatory Submissions

510(k) Number
K170143

Owner / Operator

Firm Name
BIONIME CORPORATION
Operator Number
9059262
Address
NO. 100, Sec. 2, Daqing St., SOUTH DIST.
City
TAICHUNG CITY
State
TW-NOTA
Postal Code
40242
Country
TW

Products

Device Name Product Code
System, Test, Blood Glucose, Over The Counter NBW

Proprietary Names

GE Blood Glucose Monitoring System 180 Rightest Blood Glucose Monitoring System GM280B Rightest Blood Glucose Monitoring System GM280 GE Blood Glucose Monitoring System 182 Diathrive+ Bluetooth Blood Glucose Monitoring System Diathrive+ Blood Glucose Monitoring System GE GlucoCapture Cielo Blood Glucose Monitoring System GE GlucoCapture Cielo Plus Blood Glucose Monitoring System Diathrive Blood Glucose Test Strip

Establishment Types

Manufacture Medical Device