MedtechSourcebook

ClensTech Inc.dba ASEPT PAK INC.

Contract manufacturer · Malone, NY

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

FDA registration
3007177643 (openFDA record; or search FDA's registration database)
FEI number
3007177643
Registered for
FDA registration year 2026
Establishment types
Manufacturer; Contract manufacturer; Repackager or relabeler
Owner or operator
Asept Pak Inc. (FDA owner/operator no. 10024698)
Registered address
64 West Street, Malone, NY 12953
Contract listings
4 device listings, 3 product codes, first listed Feb 7, 2011
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
CAFNebulizer (Direct Patient Interface)Class IIAnesthesiologyContract manufacturingFeb 7, 2011
FQHLavage, JetClass IIGeneral hospitalContract manufacturingDec 29, 2011
MRCProducts, Contact Lens Care, Rigid Gas PermeableClass IIOphthalmicContract manufacturingDec 23, 2020