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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 9 of 12

Device	Model / Reference	Registries	Class	Status
NOVA Minimally Invasive System	320-5504C	FDA UDI	Class II	Active
Facilis™ Spinal System	661-6540	FDA UDI	Class II	Active
Orthopedic manual surgical instrument	409-1405	FDA UDI	Class I	Active
NOVA Minimally Invasive System	663-6240D	FDA UDI	Class II	Active
Facilis™ Spinal System	660-6530	FDA UDI	Class II	Active
Orthopedic manual surgical instrument	406-0103H	FDA UDI	Class I	Active
NOVA Minimally Invasive System	663-5555Y	FDA UDI	Class II	Active
Facilis™ Spinal System	662-8030	FDA UDI	Class II	Active
Facilis™ Spinal System	320-5535	FDA UDI	Class II	Active
COMET Lumbar Interbody Fusion Cage	595-12308	FDA UDI	Class II	Active
COMET Lumbar Interbody Fusion Cage	595-09268	FDA UDI	Class II	Active
COMET Lumbar Interbody Fusion Cage	595-14328	FDA UDI	Class II	Active
NOVA Minimally Invasive System	663-6030D	FDA UDI	Class II	Active
Facilis™ Spinal System	620-5502	FDA UDI	Class II	Active
Facilis™ Spinal System	240-4530	FDA UDI	Class II	Active
Orthopedic manual surgical instrument	406-0504B	FDA UDI	Class I	Active
COMET Lumbar Interbody Fusion Cage	595-07288	FDA UDI	Class II	Active
Facilis™ Spinal System	661-8040	FDA UDI	Class II	Active
Facilis™ Spinal System	560-1109	FDA UDI	Class II	Active
Facilis™ Spinal System	281-6540	FDA UDI	Class II	Active
Facilis™ Spinal System	661-5530	FDA UDI	Class II	Active
Orthopedic manual surgical instrument	420-1109A	FDA UDI	Class I	Active
COMET Lumbar Interbody Fusion Cage	595-10318	FDA UDI	Class II	Active
Facilis™ Spinal System	240-7550	FDA UDI	Class II	Active
Facilis™ Spinal System	240-6045	FDA UDI	Class II	Active
NOVA Minimally Invasive System	320-5515C	FDA UDI	Class II	Active
Facilis™ Spinal System	281-8055	FDA UDI	Class II	Active
NOVA Minimally Invasive System	320-5545C	FDA UDI	Class II	Active
NOVA Minimally Invasive System	320-5511C	FDA UDI	Class II	Active
NOVA Minimally Invasive System	663-7060A	FDA UDI	Class II	Active
COMET Lumbar Interbody Fusion Cage	595-17288	FDA UDI	Class II	Active
NOVA Minimally Invasive System	320-5575C	FDA UDI	Class II	Active
Facilis™ Spinal System	660-6560	FDA UDI	Class II	Active
Facilis™ Spinal System	660-6050	FDA UDI	Class II	Active
Orthopedic manual surgical instrument	409-0804	FDA UDI	Class I	Active
Facilis™ Spinal System	662-8035	FDA UDI	Class II	Active
Facilis™ Spinal System	281-7060	FDA UDI	Class II	Active
Orthopedic manual surgical instrument	420-1724	FDA UDI	Class I	Active
NOVA Minimally Invasive System	663-7045Y	FDA UDI	Class II	Active
Facilis™ Spinal System	281-8060	FDA UDI	Class II	Active
Facilis™ Spinal System	660-6030	FDA UDI	Class II	Active
Orthopedic manual surgical instrument	420-1301	FDA UDI	Class I	Active
Facilis™ Spinal System	662-5545	FDA UDI	Class II	Active
Facilis™ Spinal System	660-4535	FDA UDI	Class II	Active
NOVA Minimally Invasive System	663-7030D	FDA UDI	Class II	Active
Facilis™ Spinal System	660-7035	FDA UDI	Class II	Active
Orthopedic manual surgical instrument	405-0302	FDA UDI	Class I	Active
Facilis™ Spinal System	320-5525	FDA UDI	Class II	Active
Facilis™ Spinal System	610-3655	FDA UDI	Class II	Active
NOVA Minimally Invasive System	663-5550A	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