FIDIA FARMACEUTICI SPA

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
96102003002806986FIDIA FARMACEUTICI SPA1N2026-01-01VIA PONTE DELLA FABBRICA 3/A ABANO TERME Padova IT 35031

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
M7131797040Hyalo GYN Vaginal Hydrating Gel - Made without Parabens - HYALO GYN® Vaginal Hydrating Gel, 30g Tube - Made without Parabens is a personal lubricant for vaginal application intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body’s natural lubrication. This product is compatible with polyisoprene condoms.973-577-6202regulatory@fidiapharma.us
M7133797040Hyalo GYN Vaginal Hydrating Gel - Made without Parabens Sample - HYALO GYN® Vaginal Hydrating Gel, 10g Tube - Made without Parabens Sample is a personal lubricant for vaginal application intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body’s natural lubrication. This product is compatible with polyisoprene condoms.973-577-6202regulatory@fidiapharma.us
M713891220750010HYMOVIS® ONE 32mg/4ml syringe - HYMOVIS® ONE Viscoelastic Hyaluronan is an ultra-pure hyaluronan engineered using a proprietary process to increase viscosity, elasticity and residence time without chemical crosslinking. The hyaluronan in HYMOVIS® ONE is derived from bacterial fermentation. HYMOVIS® ONE is indicated for the treatment of pain in osteoarthritis (OA) of the knee in patients who have failed to respond adequately to conservative non-pharmacologic therapy or simple analgesics (e.g., acetaminophen). It is given by intra-articular injection in single injection regimen. The product is packaged in a one syringe pack.9735776202compliance@fidiapharma.us

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
165681460383145P950027HYALGAN(R)MOZ1997-05-28
165681159509043P180040TRILURONMOZ2019-03-26
165682061786088P150010HYMOVISMOZ2015-08-28
165681219753642K984267MODIFICATION OF BIONECT HYDROGEL FOAMMGQ1999-02-10
165681737879289K973725BIONECT CLEAR HYDROGELMGQ1998-09-22
165681233449017K973724BIONECT HYDROGEL SPRAYMGQ1998-09-22
165681439360072K973722BIONECT HYDROGEL FOAMMGQ1998-09-22
165681454915014K963004BIONECT CREAMMGQ1997-02-12
165681545377465K191052HyaloGYN Vaginal Moisturizing SuppositoriesNUC2020-01-09
165681240308206K150883HyaloGYN Vaginal Hydrating GelNUC2015-09-01
165681433811887K094039HYALO GYNNUC2010-05-07
165681468367281BK180296

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
MGQ71999-02-10
NUC32020-01-09
MOZ32019-03-26

PMA#

PMN#

GUDID#