FDA.reportPublic FDA data

NOVO NORDISK A/S

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
96818213003131673NOVO NORDISK A/S1N2026-01-01BRENNUM PARK HILLEROED Hovedstaden DK DK-3400

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
165711423395103K210258NovoFineFMI2021-06-23
165711382197461K202005NovoFine Plus 32G Tip x 4 mmFMI2020-12-19
165712008167522K182387NovoPen Echo Dial-A-Dose Insulin Delivery Device (Pen Injector)FMF2018-12-17
165711745006875K173479NovoFine 32G Tip (0.23/0.25) x 6 mm ETW (extra thin wall)FMI2018-01-17
165711643284362K162602NovoPen EchoFMF2016-10-18
165711189984943K133738NOVOFINE PLUS 32G 4 MMFMI2014-05-21
165711051318870K093109NOVOTWIST NEEDLE, MODELS 30G * 8MM (1/3) 32 G TIP * 5 MM(1/5')FMI2010-06-18
165711016246524K090111FLEXPEN NEEDLEFMI2010-02-01
165711080572543K050106NOVOFINE AUTOCOVER 30G X 8MMFMI2005-03-30
165711012223184
165711610738297
165711844645649

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
FMI72021-06-23
FMF22018-12-17

PMN#