MedtechSourcebook

ASEPTICO, INC.

Contract manufacturer · Woodinville, WA

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

FDA registration
3017604 (openFDA record; or search FDA's registration database)
FEI number
3017604
Registered for
FDA registration year 2026
Establishment types
Complaint file establishment; Specification developer; Manufacturer for export only; Manufacturer; Contract manufacturer
Owner or operator
ASEPTICO, INC. (FDA owner/operator no. 3017604)
Registered address
8333 216th St SE, Woodinville, WA 98072
Contract listings
4 device listings, 3 product codes, first listed Oct 21, 2004
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
EJBHandle, Instrument, DentalClass IDentalContract manufacturingNov 16, 2004
EKMGutta-PerchaClass IDentalContract manufacturingOct 21, 2004
EKXHandpiece, Direct Drive, Ac-PoweredClass IDentalContract manufacturingNov 6, 2007