MedtechSourcebook

CUSTOM ASSEMBLIES, INC.

Contract manufacturer · Pine Level, NC

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

FDA registration
1063382 (openFDA record; or search FDA's registration database)
FEI number
3000718854
Registered for
FDA registration year 2026
Establishment types
Manufacturer; Contract manufacturer; Repackager or relabeler
Owner or operator
CUSTOM ASSEMBLIES, INC. (FDA owner/operator no. 9026626)
Registered address
330 EAST MAIN STREET, Pine Level, NC 27568
Contract listings
2 device listings, 2 product codes, first listed Dec 14, 2012
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
GAZTubing, NoninvasiveClass IIGeneral hospitalContract manufacturingDec 14, 2012
LROGeneral Surgery TrayClass IIGeneral and plastic surgeryContract manufacturingJul 8, 2013