FDA.report

SDI DIAGNOSTICS, INC.

Matched from indexed company URL: SDI LIMITED

FDA Registration(s)

RegistrationFEINameStatusInitial importerExpiration yearAddress
12202531220253SDI DIAGNOSTICS, INC.1N2026-01-0110 Hampden Dr South Easton MA US 02375
29399561000124094SDI (North America) Inc1Y2026-01-011279 Hamilton Pkwy Itasca IL US 60143
30996358363005462533SDIX, LLC1N2020-04-25111 Pencader Dr Newark DE US 19702

Registered Device Listings

Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
302781577674484K983909MIR SPIROBANK SPIROMETERBZG1998-12-21
302781464078733K934509PULMOGUARD DISPOSABLE BATERIAL/VIRAL FILTERCAH1993-10-21
302781384608080K150515IQSense Flow Sensor MouthpieceBZG2016-01-12
302781505330096K062913ASTRAGUARD PULMONARY FUNCTION FILTERBZG2007-01-26
302781222016691K061571ASTRA 300BZG2007-01-31
302781797081932K033939FLOSENSE II, MODEL 29-8040BZG2004-01-30
1745581090251619
302781333164628

Product Codes Associated With Registrations

Product codeRegistration listing recordsLatest decision
BZG52016-01-12
CAH11993-10-21

PMN

AURA

2010-12-08

SDI LIMITED

GUDID

200 records. Showing 1-40. Next