FDA Registration
Active
🇺🇸 United States
Winx Health Inc
Reg #: 3015729142
·
FEI: 3015729142
·
Expires 2026
Products
8
Proprietary Names
7
Establishment Types
1
Classifications
8
Registration Details
- Registration Name
- Winx Health Inc
- Registration Number
- 3015729142
- FEI Number
- 3015729142
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 184 Tuckerton Rd, Unit 2
- City
- Reading
- State
- PA
- ZIP
- 19605
- Country
- US
Regulatory Submissions
- 510(k) Number
- K041273
Owner / Operator
- Firm Name
- Winx Health Inc
- Operator Number
- 10061060
- Address
- 9450 Southwest Gemini Drive, PMB 53351
- City
- Beaverton
- State
- OR
- Postal Code
- 97008
- Country
- US
- Correspondent
- Cynthia Plotch
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Test, Luteinizing Hormone (Lh), Over The Counter | NGE | Class 1 | Clinical Chemistry | No | 2019-12-06 |
| Kit, Test, Pregnancy, Hcg, Over The Counter | LCX | Class 2 | Clinical Chemistry | No | 2019-08-07 |
| Test, Urine Leukocyte | LJX | Class 1 | Hematology | No | 2020-09-15 |
| Diazo (Colorimetric), Nitrite (Urinary, Non-Quant) | JMT | Class 1 | Clinical Chemistry | No | 2020-09-15 |
| Pad, Menstrual, Unscented | HHD | Class 1 | Obstetrics/Gynecology | No | 2021-05-04 |
| Paper, Obstetric Ph | LNW | Class 1 | Clinical Chemistry | No | 2021-05-04 |
| Visual, Pregnancy Hcg, Prescription Use | JHI | Class 2 | Clinical Chemistry | No | 2022-10-17 |
| Condom | HIS | Class 2 | Obstetrics/Gynecology | No | 2022-08-09 |
Proprietary Names
Stix Ovulation Test
stix pregnancy test
Stix UTI test
Stix Pantyliner
Stix Vaginal pH Test
Stix Early Pregnancy Test
Stix Condoms
Establishment Types
Repack or Relabel Medical Device