MedtechSourcebook

COGENTIX MEDICAL, INC.

Contract manufacturer ยท Westborough, MA

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

FDA registration
1223490 (openFDA record; or search FDA's registration database)
FEI number
1000136543
Registered for
FDA registration year 2026
Establishment types
Manufacturer; Contract manufacturer
Owner or operator
COGENTIX MEDICAL, INC. (FDA owner/operator no. 9006902)
Registered address
135 Flanders Rd, Westborough, MA 01581
Contract listings
1 device listings, 1 product codes, first listed Dec 10, 2018
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
FENDevice, Cystometric, HydraulicClass IIGastroenterology and urologyContract manufacturingDec 10, 2018