FDA.reportPublic FDA data

BAUI BIOTECH CO., LTD.

Matched from indexed company URL: BAUI Biotech Co., Ltd.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30135146483013514648BAUI BIOTECH CO., LTD.1N2026-01-016F., No.8, Sec.1, Zhongxing Rd. Wugu Dist. New Taipei City TW 24872

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2047542007040986K242899NOVA Minimally Invasive SystemNKB2024-10-17
2047541863541643K191494Facilis™ Spinal SystemNKB2019-08-12
2047541014247361K191353COMET Lumbar Interbody Fusion CageMAX2020-04-14
2047541365788344K182416NOVA Minimally Invasive SystemNKB2019-06-11
2047541507970287K161231Facilis™ Spinal SystemNKB2017-01-23
2047541645820005

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
NKB52024-10-17
MAX12020-04-14

PMN#

GUDID#

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