Is this your brand? Sign in to claim ownership.

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 2 of 12

Device	Model / Reference	Registries	Class	Status
Facilis™ Spinal System	320-5545	FDA UDI	Class II	Active
NOVA Minimally Invasive System	663-6050D	FDA UDI	Class II	Active
NOVA Minimally Invasive System	320-5507C	FDA UDI	Class II	Active
NOVA Minimally Invasive System	663-6550D	FDA UDI	Class II	Active
Orthopedic manual surgical instrument	406-2905	FDA UDI	Class I	Active
NOVA Minimally Invasive System	320-5505C	FDA UDI	Class II	Active
Facilis™ Spinal System	281-7545	FDA UDI	Class II	Active
COMET Lumbar Interbody Fusion Cage	595-09328	FDA UDI	Class II	Active
Facilis™ Spinal System	661-5545	FDA UDI	Class II	Active
Orthopedic manual surgical instrument	406-0101A	FDA UDI	Class I	Active
Facilis™ Spinal System	660-4550	FDA UDI	Class II	Active
NOVA Minimally Invasive System	663-6035A	FDA UDI	Class II	Active
Facilis™ Spinal System	240-6040	FDA UDI	Class II	Active
NOVA Minimally Invasive System	663-6060A	FDA UDI	Class II	Active
NOVA Minimally Invasive System	663-6570C	FDA UDI	Class II	Active
COMET Lumbar Interbody Fusion Cage	595-13308	FDA UDI	Class II	Active
NOVA Minimally Invasive System	663-5560D	FDA UDI	Class II	Active
Facilis™ Spinal System	662-6545	FDA UDI	Class II	Active
Facilis™ Spinal System	661-7535	FDA UDI	Class II	Active
Facilis™ Spinal System	660-7055	FDA UDI	Class II	Active
Facilis™ Spinal System	660-4530	FDA UDI	Class II	Active
COMET Lumbar Interbody Fusion Cage	595-12328	FDA UDI	Class II	Active
Facilis™ Spinal System	320-5508	FDA UDI	Class II	Active
Orthopedic manual surgical instrument	406-0808	FDA UDI	Class I	Active
NOVA Minimally Invasive System	663-5525D	FDA UDI	Class II	Active
Orthopedic manual surgical instrument	420-0414C	FDA UDI	Class I	Active
NOVA Minimally Invasive System	663-6570A	FDA UDI	Class II	Active
NOVA Minimally Invasive System	663-7055C	FDA UDI	Class II	Active
Facilis™ Spinal System	240-6545	FDA UDI	Class II	Active
Orthopedic manual surgical instrument	420-1725	FDA UDI	Class I	Active
NOVA Minimally Invasive System	663-5550Y	FDA UDI	Class II	Active
COMET Lumbar Interbody Fusion Cage	595-18318	FDA UDI	Class II	Active
NOVA Minimally Invasive System	663-7040A	FDA UDI	Class II	Active
Facilis™ Spinal System	661-7045	FDA UDI	Class II	Active
Facilis™ Spinal System	281-5530	FDA UDI	Class II	Active
Facilis™ Spinal System	281-6045	FDA UDI	Class II	Active
Facilis™ Spinal System	661-6545	FDA UDI	Class II	Active
Orthopedic manual surgical instrument	420-0710A	FDA UDI	Class I	Active
Facilis™ Spinal System	281-6040	FDA UDI	Class II	Active
Orthopedic manual surgical instrument	406-3114	FDA UDI	Class I	Active
Facilis™ Spinal System	240-6530	FDA UDI	Class II	Active
Facilis™ Spinal System	281-6560	FDA UDI	Class II	Active
COMET Lumbar Interbody Fusion Cage	595-18308	FDA UDI	Class II	Active
Orthopedic manual surgical instrument	406-3005A	FDA UDI	Class I	Active
Facilis™ Spinal System	320-5509	FDA UDI	Class II	Active
NOVA Minimally Invasive System	663-7035D	FDA UDI	Class II	Active
NOVA Minimally Invasive System	663-6245Y	FDA UDI	Class II	Active
NOVA Minimally Invasive System	663-7030Y	FDA UDI	Class II	Active
NOVA Minimally Invasive System	663-5540Y	FDA UDI	Class II	Active
NOVA Minimally Invasive System	663-6530Y	FDA UDI	Class II	Active

Related Companies

Authorised Representatives

No authorised representatives on record.

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.

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