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LUMITEX

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
10001228101000122810Lumitex Medical Devices, Inc.1N2026-01-016611 W Snowville Rd Brecksville OH US 44141
30301017463030101746Lumitex, Celaya1N2026-01-01Carr. Celaya a Salvatierra Km. 17 Col. Predio Rustico las Palomas Int.1 Celaya Guanajuato MX 38150
15281081000122810LUMITEX Medical Devices, INC.1N2020-04-258443 DOW CIR. -- Strongsville OH US 44136
10001228101000122810Lumitex Medical Devices Inc.1N2020-04-258300 Dow Circle Suite 400 Strongsville OH US 44136

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1266101644615812K120820GIRAFFE BLUE SPOT PT LITELBI2012-06-08
2253221644615812K120820GIRAFFE BLUE SPOT PT LITELBI2012-06-08
3343491644615812K120820GIRAFFE BLUE SPOT PT LITELBI2012-06-08
1266101988470536K053568BILISOFT PHOTOTHERAPY SYSTEMLBI2006-04-17
2253221988470536K053568BILISOFT PHOTOTHERAPY SYSTEMLBI2006-04-17
3343491988470536K053568BILISOFT PHOTOTHERAPY SYSTEMLBI2006-04-17
1266101004552605
1266101173006799
2253221173006799
1266101289353158
3343491173006799
3249831289353158
3343491289353158

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
LBI62012-06-08

PMN#

GUDID#

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