MedtechSourcebook

Gilero, Inc

Contract manufacturer ยท Pittsboro, NC

FDA-registered (openFDA, export of Oct 21, 2026) ISO 13485: not verified

2017Product codes first listed, by year (tallest: 4)2026
FDA registration
3016733629 (openFDA record; or search FDA's registration database)
FEI number
3016733629
Registered for
FDA registration year 2026
Establishment types
Complaint file establishment; Manufacturer; Contract manufacturer
Owner or operator
Gilero, Inc (FDA owner/operator no. 10053703)
Registered address
158 Credle Street, Pittsboro, NC 27312
Contract listings
13 device listings, 11 product codes, first listed Jan 3, 2017
Certification
Not verified. We have no certification data for this facility yet.

Devices listed as contract work

Each row is an FDA product code this facility lists under its contract establishment type, with the date of its earliest such listing.

Product codeDevice (FDA name)ClassCategoryRoleFirst listed
BYYTube, Aspirating, Flexible, ConnectingClass IIGeneral hospitalContract manufacturingMay 12, 2023
BYZTrap, Sterile SpecimenClass IIGeneral hospitalContract manufacturingJan 3, 2017
BZDVentilator, Non-Continuous (Respirator)Class IIAnesthesiologyContract manufacturingMay 12, 2023
DXCClamp, VascularClass IICardiovascularContract manufacturingJan 17, 2025
EXXProbe, Rectal, Non-PoweredClass IGastroenterology and urologyContract manufacturingJul 20, 2023
FMFSyringe, PistonClass IIGeneral hospitalContract manufacturingJun 29, 2021
KDDKit, Surgical Instrument, DisposableClass IGeneral and plastic surgeryContract manufacturingJul 20, 2023
KXGApplicator, Absorbent Tipped, SterileClass IGeneral hospitalContract manufacturingJan 20, 2021
MLYVapocoolant DeviceUnclassifiedPhysical medicineContract manufacturingMar 22, 2021
PTLWire, Guide, Catheter, ExemptClass IICardiovascularContract manufacturingSep 15, 2020
QOIIntravenous Catheter Force-Activated Separation Device.Class IIGeneral hospitalContract manufacturingJun 28, 2022