FDA Registration
Active
🇲🇽 Mexico
Dexcom G6 Continuous Glucose Monitoring System
Reg #: 3010152118
·
FEI: 3010152118
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- OnCore de Mexico SA de CV dba NEOTech
- Registration Number
- 3010152118
- FEI Number
- 3010152118
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Blvd. Hector Teran Teran #20120, Nave 7-B Parque Industrial Prologis
- City
- Tijuana Baja California
- Country
- MX
Regulatory Submissions
- 510(k) Number
- K183206
Owner / Operator
- Firm Name
- ONCORE - MEXICO
- Operator Number
- 10042195
- Address
- 9340 Owensmouth Ave
- City
- Chatsworth
- State
- CA
- Postal Code
- 91311
- Country
- US
- Correspondent
- Jesus M Reyes
US Agent
- Business Name
- OnCore Manufacturing LLC dba NEO Tech
- Contact Name
- Marcos Reyes
- Address
- 9340 Owensmouth Ave
- City
- Chatsworth
- State
- CA
- ZIP
- 91311
- Country
- US
- [email protected]
- Phone
- 915 7915334
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Integrated Continuous Glucose Monitoring System, Factory Calibrated | QBJ | Class 2 | Clinical Chemistry | No | 2019-05-20 |
Proprietary Names
Dexcom G6 Continuous Glucose Monitoring System
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)
Export Device to the United States But Perform No Other Operation on Device