FDA Registration
Active
🇮🇳 India
Inito Fertility Monitor and Test Strips
Reg #: 3011878253
·
FEI: 3011878253
·
Expires 2025
Products
1
Proprietary Names
2
Establishment Types
3
Classifications
1
Registration Details
- Registration Name
- Ubio Biotechnology Systems Pvt.Ltd
- Registration Number
- 3011878253
- FEI Number
- 3011878253
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- ubio Biotechnology Systems Pvt ltd, #15A Biotechnology Zone, Kinfra Hi-Tech Park
- City
- Kalamassery Kerala
- Country
- IN
Owner / Operator
- Firm Name
- ubio Biotechnology Systems Pvt Ltd
- Operator Number
- 10089502
- Address
- No.15A, Biotechnology Zone, Kinfra Hi-Tech Park, Kalamassery
- City
- Ernakulam
- State
- Kerala
- Postal Code
- 683503
- Country
- IN
US Agent
- Business Name
- TechLink International LLC
- Contact Name
- Lilian Llull
- Address
- 16445 Collins Ave # 522, Sunny Isles, FL
- City
- Sunny Isles Beach
- State
- FL
- ZIP
- 33160
- Country
- US
- [email protected]
- Phone
- 305 2066777
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Test, Luteinizing Hormone (Lh), Over The Counter | NGE | Class 1 | Clinical Chemistry | No | 2023-12-13 |
Proprietary Names
Inito Fertility Monitor and Test Strips
Inito Fertility Test Strips
Establishment Types
Export Device to the United States But Perform No Other Operation on Device
Manufacture Medical Device for Another Party (Contract Manufacturer)
Manufacture Medical Device