MedtechSourcebook

MIDWEST TEK

Contract manufacturer ยท New Albany, IN

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

2019Product codes first listed, by year (tallest: 1)2026
FDA registration
3015525101 (openFDA record; or search FDA's registration database)
FEI number
3015525101
Registered for
FDA registration year 2026
Establishment types
Contract manufacturer
Owner or operator
Midwest Tek (FDA owner/operator no. 10060365)
Registered address
4345 Security Parkway, New Albany, IN 47150
Contract listings
2 device listings, 2 product codes, first listed May 1, 2019
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
EBGCrown And Bridge, Temporary, ResinClass IIDentalContract manufacturingMay 1, 2019
OBRMouthguard, Over-The-CounterUnclassifiedDentalContract manufacturingDec 30, 2021