MedtechSourcebook

EPIEN MEDICAL, INC.

Contract manufacturer · White Bear Lake, MN

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

FDA registration
3003428492 (openFDA record; or search FDA's registration database)
FEI number
3003428492
Registered for
FDA registration year 2026
Establishment types
Complaint file establishment; Manufacturer; Contract manufacturer
Owner or operator
EPIEN MEDICAL, INC. (FDA owner/operator no. 9088699)
Registered address
4225 White Bear Parkway, SUITE 600, White Bear Lake, MN 55110
Contract listings
1 device listings, 1 product codes, first listed Jun 16, 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
NECBandage, Liquid, Skin ProtectantClass IGeneral hospitalContract manufacturingJun 16, 2006