FDA Registration
Active
🇺🇸 United States
ANDWIN SCIENTIFIC
Reg #: 2027344
·
FEI: 2027344
·
Expires 2026
Products
4
Proprietary Names
7
Establishment Types
4
Classifications
4
Registration Details
- Registration Name
- ANDWIN SCIENTIFIC
- Registration Number
- 2027344
- FEI Number
- 2027344
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 167 W. Cochran St.
- City
- Simi Valley
- State
- CA
- ZIP
- 93065
- Country
- US
Regulatory Submissions
- 510(k) Number
- K930955
Owner / Operator
- Firm Name
- THE ANDWIN CORP.
- Operator Number
- 2027344
- Address
- 167 W. COCHRAN ST.
- City
- Simi Valley
- State
- CA
- Postal Code
- 93065
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Spatula, Cervical, Cytological | HHT | Class 2 | Obstetrics/Gynecology | No | 2012-09-13 |
| Adaptor, Holder, Syringe | IQG | Class 1 | Physical Medicine | No | 2025-08-07 |
| Kit, Screening, Urine | JXA | Class 1 | Microbiology | No | 1992-12-22 |
| Filters, Cell Collection, Tissue Processing | KET | Class 1 | Pathology | No | 1992-12-22 |
Proprietary Names
Rovers Cervex-Brush
Safetex
SAFETEX CERVICAL SCRAPER
SealSafe
BORITEX
CYTEX ONE AND CYTEX TWO
SPECULITE CYALUME
Establishment Types
Repack or Relabel Medical Device
Remanufacture Medical Device
Develop Specifications But Do Not Manufacture At This Facility
Manufacture Medical Device