FDA Registration
Active
🇰🇷 South Korea
BIONET CO., LTD.
Reg #: 3003681187
·
FEI: 3003681187
·
Expires 2026
Products
9
Proprietary Names
25
Establishment Types
1
Classifications
8
Registration Details
- Registration Name
- BIONET CO., LTD.
- Registration Number
- 3003681187
- FEI Number
- 3003681187
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 401, 34, LS-ro 91beon-gil, Dongan-gu
- City
- Anyang-si Gyeonggi
- Country
- KR
Regulatory Submissions
- 510(k) Number
- K102767
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 |
|---|---|---|---|---|---|
| Electrocardiograph | DPS | Class 2 | Cardiovascular | No | 2011-07-22 |
| Spirometer, Diagnostic | BZG | Class 2 | Anesthesiology | No | 2023-12-18 |
| Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) | MWI | Class 2 | Cardiovascular | No | 2013-12-10 |
| Monitor, Blood-Flow, Ultrasonic | HEP | Class 2 | Obstetrics/Gynecology | No | 2007-12-07 |
| LOS | No | 2007-12-07 | |||
| System, Monitoring, Perinatal | HGM | Class 2 | Obstetrics/Gynecology | No | 2006-06-30 |
| Transducer, Ultrasonic, Diagnostic | ITX | Class 2 | Radiology | No | 2022-10-27 |
| System, Imaging, Pulsed Echo, Ultrasonic | IYO | Class 2 | Radiology | No | 2022-10-27 |
| System, Imaging, Pulsed Doppler, Ultrasonic | IYN | Class 2 | Radiology | No | 2022-10-27 |
Proprietary Names
CardioXP
Cardio Q70
Cardio Q50
CardioExpress 4012
CardioExpress 5012
BM3
BM3 Plus
BabyCare
Cardio7
CardioCare2000
SX2000
CardioTouch3000
SX3000
BMS Plus
EKG-PLUS ll
Cardio7-S
CardioTouch3000-S
SpiroCare
SPM-300
FC1400
FC700
Cardio P1
SONOFINDER
SonoMe
Cardio10
Establishment Types
Manufacture Medical Device