BENCHMARK ELECTRONICS, INC.

Contract manufacturer · Winona, MN

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

FDA registration: 2133641 (openFDA record; or search FDA's registration database)
FEI number: 3000203466
Registered for: FDA registration year 2026
Establishment types: Contract manufacturer
Owner or operator: BENCHMARK ELECTRONICS, INC. (FDA owner/operator no. 1641405)
Registered address: 4065 THEURER BLVD., Winona, MN 55987
Contract listings: 47 device listings, 48 product codes, first listed Jul 12, 2006
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 code	Device (FDA name)	Class	Category	Role	First listed
DQE	Catheter, Oximeter, Fiber-Optic	Class II	Cardiovascular	Contract manufacturing	Jun 15, 2017
DQK	Computer, Diagnostic, Programmable	Class II	Cardiovascular	Contract manufacturing	Jun 15, 2017
DQR	Cannula, Catheter	Class II	Cardiovascular	Contract manufacturing	Sep 25, 2024
DSB	Plethysmograph, Impedance	Class II	Cardiovascular	Contract manufacturing	Dec 16, 2014
DWJ	System, Thermal Regulating	Class II	Cardiovascular	Contract manufacturing	Nov 27, 2017
DXG	Computer, Diagnostic, Pre-Programmed, Single-Function	Class II	Cardiovascular	Contract manufacturing	Dec 9, 2015
DXH	Transmitters And Receivers, Electrocardiograph, Telephone	Class II	Cardiovascular	Contract manufacturing	Sep 25, 2024
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Class II	Cardiovascular	Contract manufacturing	Dec 16, 2014
DXY	Implantable Pacemaker Pulse-Generator	Class III	Cardiovascular	Contract manufacturing	Nov 2, 2021
DYG	Catheter, Flow Directed	Class II	Cardiovascular	Contract manufacturing	Jul 14, 2025
ERL	Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece	Class II	Ear, nose and throat	Contract manufacturing	Jul 14, 2025
FKX	System, Peritoneal, Automatic Delivery	Class II	Gastroenterology and urology	Contract manufacturing	Dec 9, 2015
FLF	Sterilizer, Ethylene-Oxide Gas	Class II	General hospital	Contract manufacturing	Feb 17, 2015
FLL	Continuous Measurement Thermometer	Class II	General hospital	Contract manufacturing	Sep 25, 2024
FOX	Stand, Infusion	Class I	General hospital	Contract manufacturing	Sep 25, 2024
FRC	Indicator, Biological Sterilization Process	Class II	General hospital	Contract manufacturing	Mar 18, 2020
HBE	Drills, Burrs, Trephines & Accessories (Simple, Powered)	Class II	Neurology	Contract manufacturing	Jul 14, 2025
HCG	Device, Neurovascular Embolization	Class II	Neurology	Contract manufacturing	Mar 25, 2022
HWE	Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment	Class I	General and plastic surgery	Contract manufacturing	Jul 14, 2025
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Class II	Radiology	Contract manufacturing	Jul 14, 2025
JTQ	Bath, Incubators/Water, All	Class I	Microbiology	Contract manufacturing	Mar 18, 2020
KRD	Device, Vascular, For Promoting Embolization	Class II	Cardiovascular	Contract manufacturing	Mar 25, 2022
KZA	Device, Vein Location, Liquid Crystal	Class I	General hospital	Contract manufacturing	Dec 28, 2010
LGW	Stimulator, Spinal-Cord, Totally Implanted For Pain Relief	Class III	Neurology	Contract manufacturing	Jul 27, 2015
LWO	Pulse-Generator, Single Chamber, Sensor Driven, Implantable	Class III	Cardiovascular	Contract manufacturing	Nov 2, 2021
LWP	Implantable Pulse Generator, Pacemaker (Non-Crt)	Class III	Cardiovascular	Contract manufacturing	Jul 12, 2006
LWS	Implantable Cardioverter Defibrillator (Non-Crt)	Class III	Cardiovascular	Contract manufacturing	Jul 12, 2006
MHY	Stimulator, Electrical, Implanted, For Parkinsonian Tremor	Class III	Neurology	Contract manufacturing	Dec 21, 2016
MUD	Oximeter, Tissue Saturation	Class II	Cardiovascular	Contract manufacturing	Apr 3, 2020
MVK	Wearable Automated External Defibrillator	Class III	Cardiovascular	Contract manufacturing	Nov 2, 2021
MWJ	Electrocardiograph, Ambulatory (Without Analysis)	Class II	Cardiovascular	Contract manufacturing	Sep 25, 2024
NHL	Stimulator, Electrical, Implanted, For Parkinsonian Symptoms	Class III	Neurology	Contract manufacturing	Dec 21, 2016
NIK	Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)	Class III	Cardiovascular	Contract manufacturing	Jul 12, 2006
NKE	Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)	Class III	Cardiovascular	Contract manufacturing	Jul 12, 2006
NVZ	Pulse Generator, Permanent, Implantable	Class III	Cardiovascular	Contract manufacturing	Jul 12, 2006
OHV	Focused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption	Class II	General and plastic surgery	Contract manufacturing	Jul 14, 2025
OJX	Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode	Class III	Cardiovascular	Contract manufacturing	Jul 12, 2006
OLO	Orthopedic Stereotaxic Instrument	Class II	Neurology	Contract manufacturing	Jul 14, 2025
OSR	Pacemaker/Icd/Crt Non-Implanted Components	Class III	Cardiovascular	Contract manufacturing	Jul 12, 2006
OUG	Medical Device Data System	Class I	General hospital	Contract manufacturing	Nov 2, 2021
PJS	Stimulator, Electrical, Implanted, For Essential Tremor	Class III	Neurology	Contract manufacturing	Dec 21, 2016
PMP	Dorsal Root Ganglion Stimulator For Pain Relief	Class III	Neurology	Contract manufacturing	Jun 12, 2026
PNJ	Leadless Pacemaker	Class III	Cardiovascular	Contract manufacturing	Jun 15, 2022
QAQ	Adjunctive Predictive Cardiovascular Indicator	Class II	Cardiovascular	Contract manufacturing	Dec 17, 2018
QEM	Cerebral Oximeter	Class II	Cardiovascular	Contract manufacturing	Jul 14, 2025
QMS	Adjunctive Open Loop Fluid Therapy Recommender	Class II	Cardiovascular	Contract manufacturing	Sep 25, 2024
QNL	Medium-Term Adjunctive Predictive Cardiovascular Indicator	Class II	Cardiovascular	Contract manufacturing	Sep 25, 2024
QRB	Stimulator, Spinal-Cord, Totally Implanted For Relief Of Pain Due To Diabetic Neuropathy	Class III	Neurology	Contract manufacturing	Jul 27, 2015