FDA Registration
Active
🇺🇸 United States
EZ Level Pregnancy Test Strips
Reg #: 3013679502
·
FEI: 3013679502
·
Expires 2025
Products
1
Proprietary Names
6
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- PREGMATE LLC
- Registration Number
- 3013679502
- FEI Number
- 3013679502
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 3804 N 29th Ave
- City
- Hollywood
- State
- FL
- ZIP
- 33020
- Country
- US
Regulatory Submissions
- 510(k) Number
- K213808
Owner / Operator
- Firm Name
- PREGMATE LLC
- Operator Number
- 10055200
- Address
- 2268 ANCHOR CT
- City
- Fort Lauderdale
- State
- FL
- Postal Code
- 33312
- Country
- US
- Correspondent
- VIKTAR MAROZAU
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Kit, Test, Pregnancy, Hcg, Over The Counter | LCX | Class 2 | Clinical Chemistry | No | 2023-01-17 |
Proprietary Names
EZ Level Pregnancy Test Strips
Pregmate Pregnancy Test Strips
Pregmate Ovulation and Pregnancy Midstream Test
Pregmate Ovulation and Pregnancy Test Strips
EZ Level Ovulation and Pregnancy Test Strips
Pregmate Pregnancy Midsream Test
Establishment Types
Repack or Relabel Medical Device