FDA.reportPublic FDA data

BIOTEM CO., LTD.

Matched from indexed company URL: Biotem Co., ltd

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30096116453009611645BIOTEM CO., LTD.1N2026-01-01# 422, Sasang-ro, Sasang-gu Busan KR 46925

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2173421328959113K222144IR SLA Type Implant SystemDZE2023-06-14
2173421456829349K222142BR SLA Type Implant SystemDZE2023-06-24
2173421832717049K190641AR_N SLA Type Implant SystemDZE2020-02-21
2173421385018312K171297AR_N Type Implant SystemDZE2018-01-31
2173421641604012K171185IR Type Implant SystemDZE2017-12-01
2173421195468822K171179BR Type Implant SystemDZE2018-02-09
2173421378673780
2173421417963551
2173421469112234
2173421785738296

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
DZE92023-06-24

PMN#

GUDID#

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