FDA.reportPublic FDA data

EMMY MEDICAL, LLC

Matched from indexed company URL: Emmy Medical, LLC.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30103148363010314836EMMY MEDICAL, LLC1N2026-01-0184 Byron Rd Weston MA US 02493

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
00866403000203Cystosure - Cystosure XL, 16 Fr, silicone catheter7758007300ron@cystosure.com
00866403000210Cystosure - 16Fr Cystosure Plus, 16Fr, silicone catheter7758007300ron@cystosure.com
00866403000265Cystosure - Cystosure Scope, 30 deg, 2.7 mm OD, 270 mm long7758007300ron@cystosure.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1805682052841637K181346CystoSure Plus CatheterEZL2018-08-06
1805681767025441K172422Kohli Urinary Drainage CatheterEZL2018-02-09
1805681156950806K142194CytoSure Urinary Access SystemFAJ2014-12-19

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
EZL22018-08-06
FAJ12014-12-19

PMN#

GUDID#