FDA Registration
Active
🇰🇷 South Korea
BabyCare
Reg #: 3003681187
·
FEI: 3003681187
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- BIONET CO., LTD.
- Registration Number
- 3003681187
- FEI Number
- 3003681187
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 401, 34, LS-ro 91beon-gil, Dongan-gu
- City
- Anyang-si Gyeonggi
- Country
- KR
Regulatory Submissions
- 510(k) Number
- K023082
Owner / Operator
- Firm Name
- Bionet Co., Ltd.
- Operator Number
- 9052948
- Address
- 5F, 61 Digital-ro 31 gil, Guro-gu
- City
- Seoul
- State
- KR-11
- Postal Code
- 08375
- Country
- KR
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Monitor, Blood-Flow, Ultrasonic | HEP | Class 2 | Obstetrics/Gynecology | No | 2007-12-07 |
Proprietary Names
BabyCare
Establishment Types
Manufacture Medical Device