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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 7 of 12

Device	Model / Reference	Registries	Class	Status
NOVA Minimally Invasive System	663-6030A	FDA UDI	Class II	Active
Facilis™ Spinal System	240-7545	FDA UDI	Class II	Active
COMET Lumbar Interbody Fusion Cage	595-17318	FDA UDI	Class II	Active
Facilis™ Spinal System	240-5040	FDA UDI	Class II	Active
Facilis™ Spinal System	240-8050	FDA UDI	Class II	Active
Orthopedic manual surgical instrument	406-1208	FDA UDI	Class I	Active
Facilis™ Spinal System	661-6035	FDA UDI	Class II	Active
Orthopedic manual surgical instrument	406-0103D	FDA UDI	Class I	Active
Facilis™ Spinal System	661-6530	FDA UDI	Class II	Active
NOVA Minimally Invasive System	320-5517C	FDA UDI	Class II	Active
Facilis™ Spinal System	662-7050	FDA UDI	Class II	Active
Facilis™ Spinal System	662-5540	FDA UDI	Class II	Active
Facilis™ Spinal System	281-6250	FDA UDI	Class II	Active
COMET Lumbar Interbody Fusion Cage	595-11308	FDA UDI	Class II	Active
Facilis™ Spinal System	660-6035	FDA UDI	Class II	Active
NOVA Minimally Invasive System	320-5585C	FDA UDI	Class II	Active
NOVA Minimally Invasive System	663-6250A	FDA UDI	Class II	Active
Orthopedic manual surgical instrument	406-0301A	FDA UDI	Class I	Active
Facilis™ Spinal System	661-8045	FDA UDI	Class II	Active
Orthopedic manual surgical instrument	409-0829B	FDA UDI	Class I	Active
Facilis™ Spinal System	240-7535	FDA UDI	Class II	Active
Facilis™ Spinal System	662-6550	FDA UDI	Class II	Active
NOVA Minimally Invasive System	663-6545D	FDA UDI	Class II	Active
Facilis™ Spinal System	281-7045	FDA UDI	Class II	Active
COMET Lumbar Interbody Fusion Cage	595-16288	FDA UDI	Class II	Active
Facilis™ Spinal System	281-5540	FDA UDI	Class II	Active
Facilis™ Spinal System	662-6245	FDA UDI	Class II	Active
Orthopedic manual surgical instrument	405-0904J	FDA UDI	Class I	Active
COMET Lumbar Interbody Fusion Cage	595-18328	FDA UDI	Class II	Active
Orthopedic manual surgical instrument	405-0555D	FDA UDI	Class I	Active
Orthopedic manual surgical instrument	420-1107B	FDA UDI	Class I	Active
Facilis™ Spinal System	281-6530	FDA UDI	Class II	Active
Facilis™ Spinal System	240-7040	FDA UDI	Class II	Active
NOVA Minimally Invasive System	663-6530D	FDA UDI	Class II	Active
Orthopedic manual surgical instrument	420-3207	FDA UDI	Class I	Active
NOVA Minimally Invasive System	663-5535D	FDA UDI	Class II	Active
NOVA Minimally Invasive System	320-5555C	FDA UDI	Class II	Active
NOVA Minimally Invasive System	663-6560Y	FDA UDI	Class II	Active
Facilis™ Spinal System	240-8030	FDA UDI	Class II	Active
Facilis™ Spinal System	281-6050	FDA UDI	Class II	Active
Facilis™ Spinal System	240-8060	FDA UDI	Class II	Active
Facilis™ Spinal System	660-7530	FDA UDI	Class II	Active
Orthopedic manual surgical instrument	420-3304A	FDA UDI	Class I	Active
COMET Lumbar Interbody Fusion Cage	595-10328	FDA UDI	Class II	Active
Facilis™ Spinal System	281-6545	FDA UDI	Class II	Active
NOVA Minimally Invasive System	663-7040C	FDA UDI	Class II	Active
Facilis™ Spinal System	661-7550	FDA UDI	Class II	Active
NOVA Minimally Invasive System	663-7030A	FDA UDI	Class II	Active
NOVA Minimally Invasive System	663-5545D	FDA UDI	Class II	Active
Facilis™ Spinal System	240-6560	FDA UDI	Class II	Active

Related Companies

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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