FDA Registration
Active
🇺🇸 United States
HUEDX
Reg #: 3040090771
·
FEI: 3040090771
·
Expires 2026
Products
1
Proprietary Names
3
Establishment Types
2
Classifications
1
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Registration Details
- Registration Name
- HUEDX
- Registration Number
- 3040090771
- FEI Number
- 3040090771
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 2929 Arch St Fl 4
- City
- Philadelphia
- State
- PA
- ZIP
- 19104
- Country
- US
Owner / Operator
- Firm Name
- HueDx
- Operator Number
- 10093949
- Address
- 2929 Arch St, Fl 4
- City
- Philadelphia
- State
- PA
- Postal Code
- 19104
- Country
- US
- Correspondent
- Brianna Wronko
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Test, Luteinizing Hormone (Lh), Over The Counter | NGE | Class 1 | Clinical Chemistry | No | 2025-08-20 |
Proprietary Names
HueFertility Luteinizing hormone Dipstick (Urine)
LH Rapid Test Kit
HueFertility Ovulation
Establishment Types
Repack or Relabel Medical Device
Develop Specifications But Do Not Manufacture At This Facility