MedtechSourcebook

MEDELA LLC

Contract manufacturer · McHenry, IL

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

FDA registration
1419937 (openFDA record; or search FDA's registration database)
FEI number
1419937
Registered for
FDA registration year 2026
Establishment types
Specification developer; Manufacturer; Contract manufacturer; Repackager or relabeler
Owner or operator
MEDELA AG (FDA owner/operator no. 8030974)
Registered address
1101 CORPORATE DR., McHenry, IL 60050
Contract listings
3 device listings, 2 product codes, first listed Jan 7, 2013
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
HGXPump, Breast, PoweredClass IIObstetrics and gynecologyContract manufacturingDec 17, 2015
OMPNegative Pressure Wound Therapy Powered Suction PumpClass IIGeneral and plastic surgeryContract manufacturingJan 7, 2013