FDA Registration
Active
🇺🇸 United States
BIOWY CORPORATION
Reg #: 3013233645
·
FEI: 3013233645
·
Expires 2026
Products
3
Proprietary Names
4
Establishment Types
2
Classifications
3
Registration Details
- Registration Name
- BIOWY CORPORATION
- Registration Number
- 3013233645
- FEI Number
- 3013233645
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 27031 Vista Terrace
- City
- Lake Forest
- State
- CA
- ZIP
- 92630
- Country
- US
Regulatory Submissions
- 510(k) Number
- K233658
Owner / Operator
- Firm Name
- Biowy Corporation
- Operator Number
- 10057786
- Address
- 27031 Vista Terrace, 27002 Vista Terrace
- City
- Lake Forest
- State
- CA
- Postal Code
- 92630
- Country
- US
- Correspondent
- Zhihua - Lu
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Tube, Tympanostomy | ETD | Class 2 | Ear, Nose, Throat | No | 2024-09-04 |
| Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days | LJS | Class 2 | General Hospital | No | 2018-05-25 |
| Container, Frozen Donor Tissue Storage | LPZ | Class U | Unknown | No | 2018-06-21 |
Proprietary Names
Biowy Tym Tube
Biowy Corporation
BIOWY FREEZING BAG
Biowy PICC-S Kit
Establishment Types
Manufacture Medical Device
Develop Specifications But Do Not Manufacture At This Facility