MedtechSourcebook

ALKEN, INC. D/B/A POLHEMUS

Contract manufacturer · Colchester, VT

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

FDA registration
1000246715 (openFDA record; or search FDA's registration database)
FEI number
1000246715
Registered for
FDA registration year 2026
Establishment types
Complaint file establishment; Contract manufacturer
Owner or operator
Alken, Inc. d/b/a Polhemus (FDA owner/operator no. 10028587)
Registered address
40 Hercules Drive, Colchester, VT 05446
Contract listings
1 device listings, 1 product codes, first listed Apr 28, 2026
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
JAKSystem, X-Ray, Tomography, ComputedClass IIRadiologyContract manufacturingApr 28, 2026