Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3001040364

FEI Number

3001040364

Entity Name

SHIMADZU U.S.A. MANUFACTURING, INC.

City/State/Country

Canby, OR, US

Establishment Address

1900 SE 4TH AVE, Canby, OR 97013, US

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Shimadzu Corporation (Owner Number: 8030233)

Owner / Operator Contact Address

1 NISHINOKYO KUWABARA-CHO, KYOTO-SHI, JP-26 604-8511, JP

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Degassing Unit DGU-20A5R CL UV-VIS Detector SPD-20A CL UV-VIS Detector SPD-20AV CL Degassing Unit DGU-20A3R CL Column Oven CTO-20AC CL Nexera CL Liquid Chromatograph LC-20ADXR CL Nexera CL Liquid Chromatograph LC-30AD CL Communications Bus Module CBM-20A CL Communications Bus Module CBM-20Alite CL Reservoir Switching Valve Kit for LC-30AD CL Nexera CL Autosampler SIL-20ACXR CL Valve Unit FCV-20AH2 CL Prominence CL Liquid Chromatograph LC-20AD CL Nexera CL Column Oven CTO-30A CL Nexera CL Diode Array Detector SPD-M30A CL Nexera CL Autosampler SIL-30ACMP CL Prominence CL Autosampler SIL-20ACHT CL Valve Unit FCV-32AH CL Prominence CL Autosampler SIL-20AC CL LC-30AD CL Low Volume LPGE KIT Nexera CL Autosampler SIL-30AC CL Diode Array Detector SPD-M20A CL Prominence CL Autosampler SIL-20AHT CL Valve Unit FCV-36AH CL SOLVENT DELIVERY MODULE LC-40D X3 CL SOLVENT DELIVERY MODULE LC-40D XR CL AUTO SAMPLER SIL-40C X3 CL COLUMN OVEN CTO-40C CL SOLVENT DELIVERY MODULE LC-40B X3 CL DEGASSING UNIT DGU-405 CL FLOW CHANNEL SELECTION VALVE FCV-S CL AUTO SAMPLER SIL-40C XR CL SYSTEM CONTROLLER CBM-40 CL PLATE CHANGER CL UV-VIS DETECTOR SPD-40 CL LCMS-8040 CL LCMS-8050 CL LCMS-8060 CL GCMS-QP2020 CL LCMS-8045 CL LCMS-8060NX CL GCMS-TQ8050 CL

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KIE	Apparatus, High Pressure Liquid Chromatography	Clinical Chemistry	Class 1	862.2260	2013-11-26
DOP	Mass Spectrometer, Clinical Use	Clinical Chemistry	Class 1	862.2860	2013-11-29

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Shimadzu Corporation

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3003927316	SHIMANE SHIMADZU CORPORATION	IZUMO Shimane, JP
3010607747	SHIMADZU CORPORATION ANALYTICAL&MEASURING INSTRUMENTS DIV.	KYOTO, JP
8030233	SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION	KYOTO, JP

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0037-2024	AB Sciex, LLC	1	API3200MD Mass Spectrometer, Part Number 4466230
Z-0038-2024	AB Sciex, LLC	1	4500MD Triple Quad Mass Spectrometer, Part Number 5032522
Z-0039-2024	AB Sciex, LLC	1	Citrine QTRAP Mass Spectrometer, Part Number 5063685
Z-0040-2024	AB Sciex, LLC	1	Citrine Triple Quad Mass Spectrometer, Part Number 5063684

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3001040364. Last updated year: 2026. Please use registration number 3001040364 when referencing this establishment in official correspondence.