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Sign in to claim this brandBistos Co., Ltd.
South Korea·KR-MF-000035951
Last updated September 17, 2026
Information
- Country
- South Korea
- Address
- 5F and 1502ho, Building D, Gwacheon Pentaone, 117, Gwacheon-daero 12-gil, Gwacheon-si, Gyeonggi-do, South Korea
- Website
- www.bistos.co.kr
- —
- —
- [email protected]
- Phone
- +82 31 750 0340
- PRRC Contact
- Taijun Kang
- EUDAMED SRN
- KR-MF-000035951
- FDA FEI Number
- 3006179052
- DUNS Number
- 689908411
Catalogue (33)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Hi bebe super | BT-150L | FDA UDI | Class II | Active |
| Hi-bebe | BT-200S | FDA UDI | Class II | Active |
| Hi bebe super | BT-150S | FDA UDI | Class II | Active |
| BiliTouchTM | Motif Phototherapy Blanket | FDA UDI | Class II | Active |
| Hi bebe plus | BT-100 | FDA UDI | Class II | Active |
| Hi-bebe | BT-200L | FDA UDI | Class II | Active |
| Duo Double Electric Breast Pump | MD-20.2 | FDA UDI | Class II | Active |
| Infant Phototherapy Equipment | BT-450 | FDA UDI | Class II | Active |
| Hi-bebe | BT-200C | FDA UDI | Class II | Active |
| Hi-dop | BT-200V | FDA UDI | Class II | Active |
| Duo Double Electric Breast Pump | AAA0021 | FDA UDI | Class II | Active |
| Head-worn light | BT-410A | EUDAMEDFDA UDI | Class I | Active |
| Infant Phototherapy Equipment | K210289 | FDA 510(k) | Class II | Active |
| Bt-1000 | K232991 | FDA 510(k) | Class II | Active |
| Hi bebe super (Models BT-150S and BT-150L) | K200675 | FDA 510(k) | Class II | Active |
| Bt-200v Vascular Doppler | K121267 | FDA 510(k) | Class II | Active |
| Fetal Monitor, Models Bt-300 And Bt-200 | K052190 | FDA 510(k) | Class II | Active |
| Model BT-220L and BT-220C | K142799 | FDA 510(k) | Class II | Active |
| Hi bebe super (BT-150B) | K251512 | FDA 510(k) | Class II | Active |
| Fetal monitor | BT-350 | EUDAMED | Class IIa | Active |
| Gateway | BT-710 | EUDAMED | Class IIb | Active |
| Head-worn light | BT-410F | EUDAMEDFDA UDI | Class I | Active |
| Neonatal Phototherapy Unit | BT-400 | EUDAMED | Class IIa | Active |
| Fetal monitor | BT-300 | EUDAMED | Class IIa | Active |
| Fetal monitor | FM20 | EUDAMEDFDA 510(k) | Class IIa | Active |
| Infant warmer | BT-550 | EUDAMED | Class IIb | Active |
| Hi-dop | BT-200V | EUDAMED | Class IIa | Active |
| Hi bebe plus | BT-100 | EUDAMED | Class IIa | Active |
| Infant incubator | BT-500 | EUDAMED | Class IIb | Active |
| Ultrasound Doppler system with Probes | BT-250 | EUDAMED | Class IIa | Active |
| Patient Monitor | BT-780 | EUDAMED | Class IIb | Active |
| Patient Monitor | BT-770 | EUDAMED | Class IIb | Active |
| Hi-bebe | BT-200L | EUDAMED | Class IIa | Active |
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