MedtechSourcebook

Trelleborg Sealing Solutions US, Inc

Contract manufacturer ยท Delano, MN

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

2019Product codes first listed, by year (tallest: 5)2026
FDA registration
3003932293 (openFDA record; or search FDA's registration database)
FEI number
3003932293
Registered for
FDA registration year 2026
Establishment types
Contract manufacturer
Owner or operator
Trelleborg Sealing Solutions US, Inc (FDA owner/operator no. 10059425)
Registered address
740 7TH ST S, Delano, MN 55328
Contract listings
8 device listings, 7 product codes, first listed Jan 14, 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
BYGMask, OxygenClass IAnesthesiologyContract manufacturingJan 14, 2019
CATCannula, Nasal, OxygenClass IAnesthesiologyContract manufacturingJan 14, 2019
DTLAdaptor, Stopcock, Manifold, Fitting, Cardiopulmonary BypassClass IICardiovascularContract manufacturingFeb 23, 2022
LWPImplantable Pulse Generator, Pacemaker (Non-Crt)Class IIICardiovascularContract manufacturingMay 31, 2022
LWSImplantable Cardioverter Defibrillator (Non-Crt)Class IIICardiovascularContract manufacturingMay 31, 2022
NVNDrug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker ElectrodesClass IIICardiovascularContract manufacturingMay 31, 2022
NVYPermanent Defibrillator ElectrodesClass IIICardiovascularContract manufacturingMay 31, 2022