Is this your brand? Sign in to claim ownership.
Sign in to claim this brandBAUI BIOTECH CO. LTD.
US
Last updated May 23, 2026
Information
- Country
- US
- Address
- —
- Website
- —
- —
- —
- —
- Phone
- —
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 656775504
Catalogue (592)
Page 12 of 12| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Facilis™ Spinal System | 660-7050 | FDA UDI | Class II | Active |
| Facilis™ Spinal System | 660-7030 | FDA UDI | Class II | Active |
| Facilis™ Spinal System | 661-8050 | FDA UDI | Class II | Active |
| Facilis™ Spinal System | 156-1216 | FDA UDI | Class II | Active |
| Facilis™ Spinal System | 661-7540 | FDA UDI | Class II | Active |
| Facilis™ Spinal System | 240-7030 | FDA UDI | Class II | Active |
| Orthopedic manual surgical instrument | 408-3201 | FDA UDI | Class I | Active |
| COMET Lumbar Interbody Fusion Cage | 595-12318 | FDA UDI | Class II | Active |
| Facilis™ Spinal System | 662-8045 | FDA UDI | Class II | Active |
| Orthopedic manual surgical instrument | 406-1207 | FDA UDI | Class I | Active |
| NOVA Minimally Invasive System | 663-6055Y | FDA UDI | Class II | Active |
| Facilis™ Spinal System | 661-8030 | FDA UDI | Class II | Active |
| Orthopedic manual surgical instrument | 409-1404 | FDA UDI | Class I | Active |
| COMET Lumbar Interbody Fusion Cage | 595-11318 | FDA UDI | Class II | Active |
| Orthopedic manual surgical instrument | 405-0801B | FDA UDI | Class I | Active |
| NOVA Minimally Invasive System | 663-5560C | FDA UDI | Class II | Active |
| NOVA Minimally Invasive System | 663-7045D | FDA UDI | Class II | Active |
| Facilis™ Spinal System | 240-7555 | FDA UDI | Class II | Active |
| Facilis™ Spinal System | 240-7045 | FDA UDI | Class II | Active |
| Facilis™ Spinal System | 662-6035 | FDA UDI | Class II | Active |
| COMET Lumbar Interbody Fusion Cage | 595-17308 | FDA UDI | Class II | Active |
| Orthopedic manual surgical instrument | 409-0829 | FDA UDI | Class I | Active |
| NOVA Minimally Invasive System | 663-7030C | FDA UDI | Class II | Active |
| Facilis™ Spinal System | 320-5504 | FDA UDI | Class II | Active |
| Facilis™ Spinal System | 661-5550 | FDA UDI | Class II | Active |
| NOVA Minimally Invasive System | 663-7035C | FDA UDI | Class II | Active |
| Facilis™ Spinal System | 320-5530 | FDA UDI | Class II | Active |
| NOVA Minimally Invasive System | 663-5525C | FDA UDI | Class II | Active |
| Facilis™ Spinal System | 660-6540 | FDA UDI | Class II | Active |
| Orthopedic manual surgical instrument | 409-2602 | FDA UDI | Class I | Active |
| Orthopedic manual surgical instrument | 420-0410C | FDA UDI | Class I | Active |
| Orthopedic manual surgical instrument | 420-0714A | FDA UDI | Class I | Active |
| Orthopedic manual surgical instrument | 406-0103 | FDA UDI | Class I | Active |
| Orthopedic manual surgical instrument | 409-0813B | FDA UDI | Class I | Active |
| Orthopedic manual surgical instrument | 420-0412C | FDA UDI | Class I | Active |
| Orthopedic manual surgical instrument | 406-3104 | FDA UDI | Class I | Active |
| Orthopedic manual surgical instrument | 420-0411C | FDA UDI | Class I | Active |
| COMET Lumbar Interbody Fusion Cage | K191353 | FDA 510(k) | Class II | Active |
| Facilis™ Spinal System | K161231 | FDA 510(k) | Class II | Active |
| NOVA Minimally Invasive System | K242899 | FDA 510(k) | Class II | Active |
| NOVA Minimally Invasive System | K182416 | FDA 510(k) | Class II | Active |
| Facilis™ Spinal System | K191494 | FDA 510(k) | Class II | Active |
Related Companies
Authorised Representatives
No authorised representatives on record.
Importers
Not available yet.
Notified Bodies
Not available yet.
Authorities
Not available yet.
FDA Establishments (1)
Establishments registered with the FDA under this company group, matched by name.
- Baui Biotech Co., Ltd. New Taipei City · TW FEI 3013514648