NIDEK MEDICAL PRODUCTS, INC.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
10392151039215NIDEK MEDICAL PRODUCTS, INC.1N2026-01-013949 VALLEY EAST INDUSTRIAL DR Birmingham AL US 35217

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
00038214000028MARK 5 NUVO LITE - 230V/ 50HZ STD OXYGEN CONCENTRATOR - EURO PLUG800-822-9255info@nidekmedical.com
00038214000035MARK 5 NUVO LITE - 230V/50HZ OCSI OXYGEN CONCENTRATOR - EURO PLUG800-822-9255info@nidekmedical.com
00038214000066MARK 5 NUVO LITE - 230V/50HZ OCSI OXYGEN CONCENTRATOR - ISRAELI PLUG800-822-9255info@nidekmedical.com
00038214002466NUVO NANO - PORTABLE OXYGEN CONCENTRATOR800-822-9255info@nidekmedical.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
731461894422180K192693Nuvo Nano Portable Oxygen ConcentratorCAW2020-05-07
731461913222471K123738MARK 5 NUVO LITE OCSI, MARK 5 NUVO LITE STDCAW2013-02-28
731462036666831K093308MARK 5 NUVO 8 OCSI, MARK 5 NUVO 8 STDCAW2010-01-14
731461695491564K020797PULMO-MIST COMPRESSOR MODEL # 4323BTI2002-05-03
731461173130973
731461176425669

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
CAW32020-05-07
BTI12002-05-03

PMN#

GUDID#

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