Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3024137003

FEI Number

3024137003

Entity Name

Barco (Suzhou) Healthcare Technology Co., Ltd.

City/State/Country

Suzhou Jiangsu, CN

Establishment Address

No.111, Sutong Road, Suzhou Industrial Park, Suzhou Jiangsu 215021, CN

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

BARCO NV (Owner Number: 9031117)

Owner / Operator Contact Address

Beneluxpark 21, Kortrijk, BE-VWV 8500, BE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

MDSC-8258 MDSC-2226 MDSC-2232 MDSC-8232 AMM215WTD MDSC-8255 AMM215WTTP MDSC-8358 MDSC-2326 AMM240ED MDSC-2324 MDSC-8231 MDSC-8331 MDSC-8427 MDFC-8232 MDSC-8532 MDSC-8527 Vividimage®32 4K MDRC-1219 MDRC-1219 HB MDRC-2222 MDRC-2324 MDRC-2321 MDRC-2422 MDRC-2424 MDRC-1419 MDRC-8132 MDRC-8127 MDRC-2421 MDNC-2123 Nio Color 2MP MDNC-6121 MDNG-6221 MDNC-3521 MDNC-2521 Nio Color 3MP Nio Color 2MP MDEC-2523 MDCC-6530 Coronis Fusion 6MP Coronis Fusion 4MP Intuitive Workflow Tools (IWT) MDCC-4430

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KQM	Camera, Surgical And Accessories	General, Plastic Surgery	Class 1	878.4160	2007-01-24
LMD	System, Digital Image Communications, Radiological	Radiology	Class 1	892.2020	2001-08-13
PGY	Display, Diagnostic Radiology	Radiology	Class 2	892.2050	2017-09-08
PGY	Display, Diagnostic Radiology	Radiology	Class 2	892.2050	2017-04-07
PGY	Display, Diagnostic Radiology	Radiology	Class 2	892.2050	2023-04-24
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2024-12-16
PGY	Display, Diagnostic Radiology	Radiology	Class 2	892.2050	2019-09-17

Official Correspondent

No official correspondent registered.

US Agent Details

Roxana Allen Business: Barco Inc. Email: roxana.allen@barco.com Phone: (678) 2008674

Related Public Records

Same Entity

BARCO NV

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3004578804	Barco, Inc	DULUTH, GA, US
3024689474	Barco Inc Portland	Portland, OR, US
9613188	BARCO N.V.	KORTRIJK West-Vlaanderen, BE
1000181154	BARCO S.R.L.	Saronno Varese, IT

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K163335	Eizo Corporation	6MP Color LCD Monitor, RadiForce RX660, RX660-AR	2016-12-15
K914997	Conmedcorp	ASP-IRRATOR	1992-01-07
K153773	Olympus Medical Systems Corp.	Disposal Lens Cleaning Sheath	2016-11-22
K940141	Micro-Medical Devices, Inc.	LAPARAOSCOPES ELECTRONIC WITH STERILE SHEATH	1994-05-19
K933812	Advanced Surgical, Inc.	ADVANCED SURGICAL, INC. CANNULA CLEANING DEVICE AND ACCESSORIES	1993-12-13

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0027-2009	Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa	2	Applied Medical, Lap Banding Kit, REF: K0398 Contains: (2) C0Q04, 5x100mm Threaded Kii Access System (1) C0604, 15x100mm Non-Threaded Separator System w/Universal Seal, for laparoscopic procedures.
Z-0028-2009	Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa	2	Applied Medical, Lap Banding Kit, REF: K0406 Contains: (1) C0658, 11x100mm Threaded Shielded Trocar w/Universal Seal (1) C0522, 5x100mm Threaded Premium Flat Blade (1) C2202, 150mm Insufflation needle (1) C0605, 15x100mm Threaded Separator Access System (1) CB030, 5mm x 35cm Direct Drive Disposable Scissors (2) C4120, 5mm x 38cm Direct Drive Grasper Reposable Cartridge, for laparoscopic procedures.
Z-0029-2009	Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa	2	Applied Medical, Lap Roux-EN-Y Kit, REF: K2129 Contains: (1) C0Q04, 5x100mm Threaded Kii Access System (1) C0130, 12x100mm Optical Separator System, Non-handled (2) C0Q10, 5x100mm Threaded Kii Cannula and Seal (1) C0605, 15mmx100mm Threaded Cannula System, for laparoscopic procedures.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3024137003. Last updated year: 2026. Please use registration number 3024137003 when referencing this establishment in official correspondence.