MedtechSourcebook

Insulet Corporation

Contract manufacturer · Acton, MA

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

FDA registration
3014585508 (openFDA record; or search FDA's registration database)
FEI number
3014585508
Registered for
FDA registration year 2026
Establishment types
Complaint file establishment; Specification developer; Manufacturer for export only; Manufacturer; Contract manufacturer
Owner or operator
INSULET CORPORATION (FDA owner/operator no. 9056196)
Registered address
100 Nagog Park, Acton, MA 01720
Contract listings
2 device listings, 2 product codes, first listed Feb 20, 2015
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
KZHIntroducer, Syringe NeedleClass IIGeneral hospitalContract manufacturingFeb 20, 2015
NSCInjector, PenClass IIGeneral hospitalContract manufacturingFeb 20, 2015