MedtechSourcebook

CLAYENS Crystal Lake , LLC

Contract manufacturer · Crystal Lake, IL

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

FDA registration
3025432964 (openFDA record; or search FDA's registration database)
FEI number
3025432964
Registered for
FDA registration year 2026
Establishment types
Contract manufacturer
Owner or operator
CLAYENS NP USA, INC (FDA owner/operator no. 10087832)
Registered address
815 Tek Dr,, Crystal Lake, IL 60014
Contract listings
8 device listings, 6 product codes, first listed Apr 16, 2023
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
FMFSyringe, PistonClass IIGeneral hospitalContract manufacturingApr 19, 2023
FMINeedle, Hypodermic, Single LumenClass IIGeneral hospitalContract manufacturingApr 16, 2023
KYWContainer, Liquid Medication, GraduatedClass IGeneral hospitalContract manufacturingApr 19, 2023
MMKContainer, SharpsClass IIGeneral hospitalContract manufacturingApr 19, 2023
NGTSaline, Vascular Access FlushClass IIGeneral hospitalContract manufacturingApr 10, 2024
PNREnteral Syringes With Enteral Specific ConnectorsClass IIGastroenterology and urologyContract manufacturingMar 17, 2026