FDA Registration
Active
🇰🇷 South Korea
Bistos co., ltd.
Reg #: 3006179052
·
FEI: 3006179052
·
Expires 2026
Products
8
Proprietary Names
33
Establishment Types
3
Classifications
8
Registration Details
- Registration Name
- Bistos co., ltd.
- Registration Number
- 3006179052
- FEI Number
- 3006179052
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 522, Geumeo-ro, Pogok-eup,, Cheoin-gu,
- City
- Yongin-si Gyeonggi
- Country
- KR
Regulatory Submissions
- 510(k) Number
- K121267
Owner / Operator
- Firm Name
- Bistos Co., Ltd.
- Operator Number
- 10023402
- Address
- 7th Fl., A Bldg., Woolim Lions Valley, 5-cha, 302 Galmachi-ro, Jungwon-gu,
- City
- Seongnam
- State
- Gyeonggi
- Postal Code
- 13201
- Country
- KR
US Agent
- Business Name
- Bistos America
- Contact Name
- Daniel Lim
- Address
- 22941 Triton Way, Suite 242
- City
- Laguna Hills
- State
- CA
- ZIP
- 92653
- Country
- US
- [email protected]
- Phone
- 949 6148745
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| System, Monitoring, Perinatal | HGM | Class 2 | Obstetrics/Gynecology | No | 2012-08-23 |
| Transducer, Ultrasonic, Obstetric | HGL | Class 2 | Obstetrics/Gynecology | No | 2011-05-19 |
| Pump, Breast, Powered | HGX | Class 2 | Obstetrics/Gynecology | No | 2016-09-07 |
| Incubator, Neonatal | FMZ | Class 2 | General Hospital | No | 2014-08-05 |
| Colposcope (And Colpomicroscope) | HEX | Class 2 | Obstetrics/Gynecology | No | 2025-04-30 |
| Unit, Neonatal Phototherapy | LBI | Class 2 | General Hospital | No | 2021-05-31 |
| Light, Examination, Medical, Battery Powered | KYT | Class 1 | General Hospital | No | 2021-03-21 |
| Transcutaneous Nerve Stimulator For Adhd | QGL | Class 2 | Neurology | No | 2024-09-03 |
Proprietary Names
Hi-dop
BT-200V
Fetal Doppler
FM-3000 Plus
BT-350
Hi bebe plus, BT-100
Duo Double Electric Breast Pump, MD-20.2
Duo Double Electric Breast Pump, AAA0021
Duo Double Electric Breast Pump, AAA0021-05
BT-300
Hi-bebe
BT-200
ENCORE
ENCORE PLUS
BT-200T
BT-500 Infant Incubator
NeoGenesis
LT-300 HD
BiliTouchTM
Infant phototherapy equipment
Motif Phototherapy Blanket
BT-450
BT-410F
BT-410A
Head-worn light
EYESCOPE
BT-220C Prenatal Monitoring System
Hi-bebe S
BT-220L Prenatal Monitoring System
PT-5000 NeoLight
BT-400 Neonatal Phototherapy
Hi bebe super
BT-1000
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Manufacture Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)