MedtechSourcebook

Mallinckrodt Manufacturing LLC

Contract manufacturer · Madison, WI

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

FDA registration
3004531588 (openFDA record; or search FDA's registration database)
FEI number
3004531588
Registered for
FDA registration year 2026
Establishment types
Manufacturer; Contract manufacturer; Remanufacturer
Owner or operator
Mallinckrodt Hospital Products IP Limited (FDA owner/operator no. 10050702)
Registered address
6603 Femrite Dr, Madison, WI 53718
Contract listings
2 device listings, 2 product codes, first listed Jul 18, 2016
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
BYXTubing, Pressure And AccessoriesClass IAnesthesiologyContract manufacturingJul 18, 2016
IYTSystem, Rebreathing, RadionuclideClass IIRadiologyContract manufacturingJul 18, 2016