MedtechSourcebook

DIAGNOSTIC GROUP LLC

Contract manufacturer ยท Eden Prairie, MN

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

1994Product codes first listed, by year (tallest: 1)2026
FDA registration
2113281 (openFDA record; or search FDA's registration database)
FEI number
2113281
Registered for
FDA registration year 2026
Establishment types
Complaint file establishment; Specification developer; Manufacturer; Contract manufacturer; Repackager or relabeler
Owner or operator
DEMANT A/S (FDA owner/operator no. 8010048)
Registered address
10395 W 70th St, Eden Prairie, MN 55344
Contract listings
2 device listings, 2 product codes, first listed Sep 21, 1994
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
BZGSpirometer, DiagnosticClass IIAnesthesiologyContract manufacturingSep 25, 2020
EWOAudiometerClass IIEar, nose and throatContract manufacturingSep 21, 1994