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BAUI BIOTECH CO. LTD.

Last updated May 23, 2026

Information

Country: US
Address: —
Website: —
LinkedIn: —
Facebook: —
Email: —
Phone: —
PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: —
DUNS Number: 656775504

Catalogue (592)

Page 6 of 12

Device	Model / Reference	Registries	Class	Status
COMET Lumbar Interbody Fusion Cage	595-09318	FDA UDI	Class II	Active
Facilis™ Spinal System	660-8060	FDA UDI	Class II	Active
Facilis™ Spinal System	281-8050	FDA UDI	Class II	Active
NOVA Minimally Invasive System	663-5540D	FDA UDI	Class II	Active
Facilis™ Spinal System	281-8045	FDA UDI	Class II	Active
NOVA Minimally Invasive System	663-6030Y	FDA UDI	Class II	Active
Facilis™ Spinal System	662-6040	FDA UDI	Class II	Active
Orthopedic manual surgical instrument	420-0407C	FDA UDI	Class I	Active
Facilis™ Spinal System	320-5548	FDA UDI	Class II	Active
Facilis™ Spinal System	660-5535	FDA UDI	Class II	Active
Facilis™ Spinal System	662-8050	FDA UDI	Class II	Active
Facilis™ Spinal System	240-5530	FDA UDI	Class II	Active
Facilis™ Spinal System	240-7540	FDA UDI	Class II	Active
NOVA Minimally Invasive System	663-5530C	FDA UDI	Class II	Active
Facilis™ Spinal System	660-4540	FDA UDI	Class II	Active
NOVA Minimally Invasive System	663-6250C	FDA UDI	Class II	Active
Facilis™ Spinal System	240-7530	FDA UDI	Class II	Active
NOVA Minimally Invasive System	663-5555C	FDA UDI	Class II	Active
COMET Lumbar Interbody Fusion Cage	595-14318	FDA UDI	Class II	Active
NOVA Minimally Invasive System	663-6045A	FDA UDI	Class II	Active
Facilis™ Spinal System	661-7530	FDA UDI	Class II	Active
NOVA Minimally Invasive System	663-5560A	FDA UDI	Class II	Active
NOVA Minimally Invasive System	663-6040A	FDA UDI	Class II	Active
Facilis™ Spinal System	662-7035	FDA UDI	Class II	Active
NOVA Minimally Invasive System	663-6565C	FDA UDI	Class II	Active
Facilis™ Spinal System	662-5530	FDA UDI	Class II	Active
Facilis™ Spinal System	662-8060	FDA UDI	Class II	Active
NOVA Minimally Invasive System	663-6520A	FDA UDI	Class II	Active
NOVA Minimally Invasive System	663-5570C	FDA UDI	Class II	Active
Orthopedic manual surgical instrument	420-1401	FDA UDI	Class I	Active
Facilis™ Spinal System	661-7030	FDA UDI	Class II	Active
Facilis™ Spinal System	662-6560	FDA UDI	Class II	Active
Facilis™ Spinal System	240-8055	FDA UDI	Class II	Active
Orthopedic manual surgical instrument	420-1107A	FDA UDI	Class I	Active
NOVA Minimally Invasive System	663-6545C	FDA UDI	Class II	Active
Orthopedic manual surgical instrument	420-1302	FDA UDI	Class I	Active
COMET Lumbar Interbody Fusion Cage	595-18288	FDA UDI	Class II	Active
NOVA Minimally Invasive System	663-6240C	FDA UDI	Class II	Active
NOVA Minimally Invasive System	663-5535C	FDA UDI	Class II	Active
Orthopedic manual surgical instrument	409-0815A	FDA UDI	Class I	Active
NOVA Minimally Invasive System	663-6240Y	FDA UDI	Class II	Active
NOVA Minimally Invasive System	663-5530A	FDA UDI	Class II	Active
NOVA Minimally Invasive System	663-5550C	FDA UDI	Class II	Active
Facilis™ Spinal System	560-3006	FDA UDI	Class II	Active
Facilis™ Spinal System	240-6535	FDA UDI	Class II	Active
NOVA Minimally Invasive System	663-5540C	FDA UDI	Class II	Active
Facilis™ Spinal System	662-7550	FDA UDI	Class II	Active
NOVA Minimally Invasive System	320-5510C	FDA UDI	Class II	Active
NOVA Minimally Invasive System	663-6525A	FDA UDI	Class II	Active
Facilis™ Spinal System	660-6535	FDA UDI	Class II	Active

Related Companies

Authorised Representatives

No authorised representatives on record.

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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