FDA Registration
Active
🇹🇼 Taiwan
LensHooke CA1 Sperm Separation Device
Reg #: 3014053517
·
FEI: 3014053517
·
Expires 2025
Products
1
Proprietary Names
2
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- BONRAYBIO CO., LTD.
- Registration Number
- 3014053517
- FEI Number
- 3014053517
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 4F., No. 118, Gongye 9th Rd., Dali Dist.
- City
- Taichung
- Country
- TW
Regulatory Submissions
- 510(k) Number
- K221810
Owner / Operator
- Firm Name
- Bonraybio Co., LTD.
- Operator Number
- 10055998
- Address
- 4F., No. 118, Gongye 9th Rd., Dali Dist.
- City
- Taichung
- State
- TW-TXG
- Postal Code
- 41280
- Country
- TW
US Agent
- Business Name
- Dynamic Biotech Inc.
- Contact Name
- Feng-Yu Lee
- Address
- 29122 Rancho Viejo Rd., Suite 212
- City
- San Juan Capistrano
- State
- CA
- ZIP
- 92675
- Country
- US
- [email protected]
- Phone
- 949 2180929
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Labware, Assisted Reproduction | MQK | Class 2 | Obstetrics/Gynecology | No | 2022-11-16 |
Proprietary Names
LensHooke CA1 Sperm Separation Device
LensHooke CA0 Sperm Separation Device
Establishment Types
Manufacture Medical Device