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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 5 of 12

Device	Model / Reference	Registries	Class	Status
Facilis™ Spinal System	661-5540	FDA UDI	Class II	Active
NOVA Minimally Invasive System	663-6540C	FDA UDI	Class II	Active
Facilis™ Spinal System	661-5535	FDA UDI	Class II	Active
COMET Lumbar Interbody Fusion Cage	595-08288	FDA UDI	Class II	Active
Facilis™ Spinal System	662-6050	FDA UDI	Class II	Active
NOVA Minimally Invasive System	663-6240A	FDA UDI	Class II	Active
NOVA Minimally Invasive System	663-6555Y	FDA UDI	Class II	Active
Facilis™ Spinal System	662-6250	FDA UDI	Class II	Active
Facilis™ Spinal System	660-5540	FDA UDI	Class II	Active
Facilis™ Spinal System	560-3012	FDA UDI	Class II	Active
NOVA Minimally Invasive System	663-6555A	FDA UDI	Class II	Active
Facilis™ Spinal System	281-5535	FDA UDI	Class II	Active
Facilis™ Spinal System	281-6030	FDA UDI	Class II	Active
NOVA Minimally Invasive System	663-5520D	FDA UDI	Class II	Active
Orthopedic manual surgical instrument	420-0707A	FDA UDI	Class I	Active
NOVA Minimally Invasive System	320-5508C	FDA UDI	Class II	Active
Facilis™ Spinal System	240-6250	FDA UDI	Class II	Active
Facilis™ Spinal System	662-7540	FDA UDI	Class II	Active
Facilis™ Spinal System	281-7550	FDA UDI	Class II	Active
Facilis™ Spinal System	662-7535	FDA UDI	Class II	Active
Facilis™ Spinal System	662-5535	FDA UDI	Class II	Active
Orthopedic manual surgical instrument	420-0409C	FDA UDI	Class I	Active
COMET Lumbar Interbody Fusion Cage	595-13318	FDA UDI	Class II	Active
Facilis™ Spinal System	661-6040	FDA UDI	Class II	Active
COMET Lumbar Interbody Fusion Cage	595-15268	FDA UDI	Class II	Active
NOVA Minimally Invasive System	320-5506C	FDA UDI	Class II	Active
Facilis™ Spinal System	662-6530	FDA UDI	Class II	Active
Facilis™ Spinal System	281-6535	FDA UDI	Class II	Active
Facilis™ Spinal System	240-5035	FDA UDI	Class II	Active
COMET Lumbar Interbody Fusion Cage	595-15318	FDA UDI	Class II	Active
NOVA Minimally Invasive System	663-6535D	FDA UDI	Class II	Active
COMET Lumbar Interbody Fusion Cage	595-10308	FDA UDI	Class II	Active
NOVA Minimally Invasive System	663-6555C	FDA UDI	Class II	Active
Facilis™ Spinal System	560-3009	FDA UDI	Class II	Active
Facilis™ Spinal System	662-7055	FDA UDI	Class II	Active
Facilis™ Spinal System	240-7060	FDA UDI	Class II	Active
NOVA Minimally Invasive System	663-6525C	FDA UDI	Class II	Active
NOVA Minimally Invasive System	663-5530D	FDA UDI	Class II	Active
Facilis™ Spinal System	281-5545	FDA UDI	Class II	Active
Facilis™ Spinal System	660-4545	FDA UDI	Class II	Active
COMET Lumbar Interbody Fusion Cage	595-08308	FDA UDI	Class II	Active
Orthopedic manual surgical instrument	190-0402	FDA UDI	Class I	Active
Facilis™ Spinal System	662-5550	FDA UDI	Class II	Active
Facilis™ Spinal System	660-6545	FDA UDI	Class II	Active
Orthopedic manual surgical instrument	420-0708A	FDA UDI	Class I	Active
Facilis™ Spinal System	662-6045	FDA UDI	Class II	Active
NOVA Minimally Invasive System	663-7055Y	FDA UDI	Class II	Active
COMET Lumbar Interbody Fusion Cage	595-11288	FDA UDI	Class II	Active
COMET Lumbar Interbody Fusion Cage	595-12268	FDA UDI	Class II	Active
NOVA Minimally Invasive System	663-6565A	FDA UDI	Class II	Active

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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