MedtechSourcebook

HELMER Inc.

Contract manufacturer · Noblesville, IN

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

FDA registration
3004973569 (openFDA record; or search FDA's registration database)
FEI number
3004973569
Registered for
FDA registration year 2026
Establishment types
Complaint file establishment; Manufacturer; Contract manufacturer
Owner or operator
HELMER INC. (FDA owner/operator no. 2182537)
Registered address
14400 Bergen Blvd, Noblesville, IN 46060
Contract listings
1 device listings, 1 product codes, first listed Aug 8, 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
JRMFreezerClass IClinical chemistryContract manufacturingAug 8, 2017