MedtechSourcebook

SMI DIV. OF SOHN MFG., INC.

Contract manufacturer · Elkhart Lake, WI

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

FDA registration
2183576 (openFDA record; or search FDA's registration database)
FEI number
2183576
Registered for
FDA registration year 2026
Establishment types
Manufacturer; Contract manufacturer
Owner or operator
SMI DIV. OF SOHN MFG., INC. (FDA owner/operator no. 2183576)
Registered address
544 Sohn Dr, Elkhart Lake, WI 53020
Contract listings
1 device listings, 1 product codes, first listed Dec 26, 2007
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
KGXTape And Bandage, AdhesiveClass IGeneral hospitalContract manufacturingDec 26, 2007