FDA.reportPublic FDA data

BODITECH MED INC.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30094912593009491259BODITECH MED INC.1N2026-01-0143, Geodudanji 1-gil, Dongnae-myeon Chuncheon Gangwon KR 24398

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
08806133010068AFIAS-50 - FPRR022732-9180770ageffon@immunostics.com
08806133010099ichroma Reader - FPRR001732-9180770ageffon@immunostics.com
08806133010242NuActor - FPRR032732-9180770ageffon@immunostics.com
08806133032008ichroma Reader - FPRR001732-9180770agenffon@immunostics.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1713441086769905K182298hemochroma PLUS SystemGKR2018-11-16
1713441846465333K170232AFIAS TSH-SP, AFIAS TSH-VB, AFIAS-6/SP Analyzer, AFIAS-6/VB AnalyzerJLW2017-10-13
1713441570051722K132167I-CHROMA IFOB WITH I-CHROMA READEROOX2014-05-02
1713441215249185K062981I-CHROMA CRP TESTDCN2007-07-13
1713441210254032
1713441009144384
1713441059181861
1713441086769905
1713441215249185
1713441294232958
1713441512595886
1713441516185013
1713441523982463
1713441570051722
1713441850070521
1713441924731563
1713441957641433

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
JLW22017-10-13
GKR12018-11-16
OOX12014-05-02
DCN12007-07-13

PMN#

GUDID#