FDA.reportPublic FDA data

AULEA MEDICAL, INC.

Matched from indexed company URL: Aulea Medical Inc.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30289778433028977843AULEA MEDICAL, INC.1N2026-01-015627 Stoneridge Dr Ste 312 Pleasanton CA US 94588

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
00860011104407Veloxion - Veloxion Resectoscope9255330018qa@auleamed.com
00860011104414Veloxion - Veloxion Fluid Control Set9255330018qa@auleamed.com
00860011104421Veloxion - Waste Management Tubing9255330018qa@auleamed.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
3201751378996721K230205Veloxion SystemFJL2023-02-24
3201751821527026K191341Veloxion Controller Kit, Veloxion Fluid Control Set, Veloxion Resectoscope, Veloxion Video Control Unit, Veloxion Roll Stand, Waste Management Tubing, Tissue Catch, Waste Management BagsFJL2019-06-13

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
FJL22023-02-24

GUDID#