MedtechSourcebook

BENCHMARK ELECTRONICS, INC.

Contract manufacturer · Rochester, MN

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

FDA registration
2133786 (openFDA record; or search FDA's registration database)
FEI number
3000204692
Registered for
FDA registration year 2026
Establishment types
Contract manufacturer
Owner or operator
BENCHMARK ELECTRONICS INC (FDA owner/operator no. 9026315)
Registered address
3535 TECHNOLOGY DR., N.W., Rochester, MN 55901
Contract listings
11 device listings, 11 product codes, first listed Jun 22, 2017
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
DWJSystem, Thermal RegulatingClass IICardiovascularContract manufacturingSep 14, 2026
EIAUnit, Operative DentalClass IDentalContract manufacturingSep 14, 2026
ERLDrill, Surgical, Ent (Electric Or Pneumatic) Including HandpieceClass IIEar, nose and throatContract manufacturingSep 25, 2017
FLLContinuous Measurement ThermometerClass IIGeneral hospitalContract manufacturingSep 14, 2026
FOXStand, InfusionClass IGeneral hospitalContract manufacturingJun 7, 2019
GEIElectrosurgical, Cutting & Coagulation & AccessoriesClass IIGeneral and plastic surgeryContract manufacturingMay 21, 2020
GXDGenerator, Lesion, RadiofrequencyClass IINeurologyContract manufacturingJun 22, 2017
GXIProbe, Radiofrequency LesionClass IINeurologyContract manufacturingJun 22, 2017
LFLInstrument, Ultrasonic SurgicalUnclassifiedGeneral and plastic surgeryContract manufacturingJun 7, 2019
OLOOrthopedic Stereotaxic InstrumentClass IINeurologyContract manufacturingDec 16, 2025
SDKTransdermal Test For Assessment Of Glomerular Filtration RateClass IIIGastroenterology and urologyContract manufacturingMar 25, 2026