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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 3 of 12

Device	Model / Reference	Registries	Class	Status
Facilis™ Spinal System	661-6030	FDA UDI	Class II	Active
Facilis™ Spinal System	662-7030	FDA UDI	Class II	Active
NOVA Minimally Invasive System	663-6060D	FDA UDI	Class II	Active
Orthopedic manual surgical instrument	406-0107A	FDA UDI	Class I	Active
Facilis™ Spinal System	660-5050	FDA UDI	Class II	Active
Orthopedic manual surgical instrument	420-1106A	FDA UDI	Class I	Active
NOVA Minimally Invasive System	663-6030C	FDA UDI	Class II	Active
Facilis™ Spinal System	240-6245	FDA UDI	Class II	Active
NOVA Minimally Invasive System	663-6545Y	FDA UDI	Class II	Active
Orthopedic manual surgical instrument	406-0403	FDA UDI	Class I	Active
Orthopedic manual surgical instrument	409-0813	FDA UDI	Class I	Active
Facilis™ Spinal System	661-6240	FDA UDI	Class II	Active
NOVA Minimally Invasive System	663-6050A	FDA UDI	Class II	Active
Orthopedic manual surgical instrument	406-0830A	FDA UDI	Class I	Active
Facilis™ Spinal System	660-5040	FDA UDI	Class II	Active
Facilis™ Spinal System	661-7055	FDA UDI	Class II	Active
Orthopedic manual surgical instrument	406-2601	FDA UDI	Class I	Active
NOVA Minimally Invasive System	663-6245D	FDA UDI	Class II	Active
COMET Lumbar Interbody Fusion Cage	595-10268	FDA UDI	Class II	Active
NOVA Minimally Invasive System	663-6570D	FDA UDI	Class II	Active
Facilis™ Spinal System	240-7055	FDA UDI	Class II	Active
Facilis™ Spinal System	662-6535	FDA UDI	Class II	Active
NOVA Minimally Invasive System	320-5525C	FDA UDI	Class II	Active
Facilis™ Spinal System	281-7040	FDA UDI	Class II	Active
NOVA Minimally Invasive System	663-5520Y	FDA UDI	Class II	Active
Facilis™ Spinal System	240-5050	FDA UDI	Class II	Active
Orthopedic manual surgical instrument	405-0502A	FDA UDI	Class I	Active
Orthopedic manual surgical instrument	409-0901B	FDA UDI	Class I	Active
Orthopedic manual surgical instrument	409-0836B	FDA UDI	Class I	Active
NOVA Minimally Invasive System	663-6535C	FDA UDI	Class II	Active
NOVA Minimally Invasive System	663-6530A	FDA UDI	Class II	Active
Orthopedic manual surgical instrument	406-0302A	FDA UDI	Class I	Active
NOVA Minimally Invasive System	663-6045D	FDA UDI	Class II	Active
COMET Lumbar Interbody Fusion Cage	595-12288	FDA UDI	Class II	Active
Orthopedic manual surgical instrument	406-0401	FDA UDI	Class I	Active
Facilis™ Spinal System	240-5550	FDA UDI	Class II	Active
Facilis™ Spinal System	660-7555	FDA UDI	Class II	Active
Facilis™ Spinal System	320-5540	FDA UDI	Class II	Active
Facilis™ Spinal System	620-5501	FDA UDI	Class II	Active
NOVA Minimally Invasive System	320-5565C	FDA UDI	Class II	Active
Orthopedic manual surgical instrument	406-0505C	FDA UDI	Class I	Active
COMET Lumbar Interbody Fusion Cage	595-16328	FDA UDI	Class II	Active
NOVA Minimally Invasive System	663-5550D	FDA UDI	Class II	Active
NOVA Minimally Invasive System	663-6035D	FDA UDI	Class II	Active
COMET Lumbar Interbody Fusion Cage	595-11328	FDA UDI	Class II	Active
Facilis™ Spinal System	662-8040	FDA UDI	Class II	Active
Facilis™ Spinal System	661-8060	FDA UDI	Class II	Active
Facilis™ Spinal System	661-8035	FDA UDI	Class II	Active
COMET Lumbar Interbody Fusion Cage	595-14288	FDA UDI	Class II	Active
NOVA Minimally Invasive System	320-5523C	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