Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

2133786

FEI Number

3000204692

Entity Name

BENCHMARK ELECTRONICS, INC.

City/State/Country

ROCHESTER, MN, US

Establishment Address

3535 TECHNOLOGY DR., N.W., ROCHESTER, MN 55901, US

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

BENCHMARK ELECTRONICS INC (Owner Number: 9026315)

Owner / Operator Contact Address

4065 Theurer Boulevard, --, Winona, MN 55987, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

No proprietary names listed under this establishment.

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FOX	Stand, Infusion	General Hospital	Class 1	880.6990	2019-06-07
SDK	Transdermal Test For Assessment Of Glomerular Filtration Rate	Unknown	Class 3	N/A	2026-03-25
LFL	Instrument, Ultrasonic Surgical	Unknown	Class U	N/A	2019-06-07
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2022-12-13
LFL	Instrument, Ultrasonic Surgical	Unknown	Class U	N/A	2024-07-09
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2025-12-16

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

BENCHMARK ELECTRONICS INC

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K970809	Somnus Medical Technologies, Inc.	BENDABLE TISSUE COAGULATING ELECTRODE WITH BENDING TOOL	1997-06-18
K222793	C.R. Bard, Inc.	WavelinQ Generator	2022-10-17
K002257	Tecno Instruments (Pvt.) , Ltd.	TECNO DISPOSABLE FINGERSWITCH PENCIL, MODEL 150-100	2000-10-19
K193591	Bowa-Electronics GmbH & Co. KG	ARC 400	2020-04-02
K192128	Sutter Medizintechnik GmbH	Sutter Arrowtip Monopolar Electrodes	2019-10-04

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0332-2022	Covidien Llc	U	Covidien Sonicision Battery Charger-intended to charge the Sonicision Reusable Battery Pack and to provide information on the battery charging progress and battery pack status Item Code: CBCA
Z-0031-06	Rita Medical Systems	2	Rita Brand Habib 4X Electrosurgical Coagulator, Catalog Number: 4401US; Product is distributed by RITA Medical Systems, Inc., One Horizon Way. Manchester, GA 32826
Z-0041-2024	Blue Belt Technologies, Inc	2	Real Intelligence CORI RI.KNEE v2.0 TKA (Total Knee Arthroplasty) software version 2.0 (2.0.0.5) Product Number: ROB10299

Similar Registrations

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3038623066	WUYI KINDA INDUSTRY & TRADE CO., LTD	JINHUA Zhejiang, CN
3008351005	Care&Care Health Products Co., Ltd	Yuanli Township Miaoli, TW

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2133786. Last updated year: 2026. Please use registration number 2133786 when referencing this establishment in official correspondence.