MedtechSourcebook

RE:BUILD TEKNA, LLC

Contract manufacturer ยท Kalamazoo, MI

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

2006Product codes first listed, by year (tallest: 1)2026
FDA registration
3005694091 (openFDA record; or search FDA's registration database)
FEI number
3005694091
Registered for
FDA registration year 2026
Establishment types
Contract manufacturer
Owner or operator
Re:Build Tekna, LLC (FDA owner/operator no. 9083159)
Registered address
3665 Midlink Drive, Kalamazoo, MI 49048
Contract listings
4 device listings, 4 product codes, first listed Feb 17, 2006
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
BZNCart, Emergency, Cardiopulmonary (Excluding Equipment)Class IAnesthesiologyContract manufacturingFeb 17, 2006
FOXStand, InfusionClass IGeneral hospitalContract manufacturingJan 8, 2017
KCTSterilization Wrap Containers, Trays, Cassettes & Other AccessoriesClass IIGeneral hospitalContract manufacturingJan 13, 2026
MDMInstrument, Manual, Surgical, General UseClass IGeneral and plastic surgeryContract manufacturingDec 17, 2016