MedtechSourcebook

CLAYENS FITCHBURG, MA

Contract manufacturer ยท Fitchburg, MA

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

2025Product codes first listed, by year (tallest: 4)2026
FDA registration
3004014152 (openFDA record; or search FDA's registration database)
FEI number
3004014152
Registered for
FDA registration year 2027
Establishment types
Contract manufacturer
Owner or operator
Clayens Fitchburg (FDA owner/operator no. 10094219)
Registered address
180 AUTHORITY DR, Fitchburg, MA 01420
Contract listings
4 device listings, 4 product codes, first listed Nov 19, 2025
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
CAZAnesthesia Conduction KitClass IIAnesthesiologyContract manufacturingNov 19, 2025
FOBBedpanClass IGeneral hospitalContract manufacturingNov 19, 2025
FZPClip, ImplantableClass IIGeneral and plastic surgeryContract manufacturingNov 19, 2025
LMGAgent, Absorbable Hemostatic, Non-Collagen BasedClass IIIGeneral and plastic surgeryContract manufacturingNov 19, 2025