Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3004105475

FEI Number

3004105475

Entity Name

Carestream Healthcare International Company, Ltd

City/State/Country

Shanghai, CN

Establishment Address

Building 7, No. 1510 Chuanqiao Road, China (Shanghai) Pilot Free Trade Zone, Shanghai 201206, CN

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Carestream Healthcare International Company Limited (Owner Number: 10095899)

Owner / Operator Contact Address

Building 7, No.1510 Chuanqiao Road, China (Shanghai) Pilot Free Trade Zone, Shanghai, CN-SH 201206, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

X-RAY GENERATOR SYSTEM CS 7200; CS 7600; CS 7600 SCAN&GO DEVICE; CS 7600 SLOT PANEL CS 1500

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
IZO	Generator, High-Voltage, X-Ray, Diagnostic	Radiology	Class 1	892.1700	2026-05-18
MUH	System, X-Ray, Extraoral Source, Digital	Dental	Class 2	872.1800	2026-06-05
EIA	Unit, Operative Dental	Dental	Class 1	872.6640	2026-06-05

Official Correspondent

Suiyue Liu

US Agent Details

Alyssa Haig Email: alyssa.haig@carestream.com Phone: (610) 8066895

Related Public Records

Same Entity

Carestream Healthcare International Company Limited

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
K950291	Fischer Imaging Corp.	DIGITAL 625HF	1995-03-23
K221008	Shanghai Handy Medical Equipment Co., Ltd.	HDR Sensor- HDR361 (Size 1), HDR Sensor- HDR461 (Size 2)	2022-06-22
K160788	Ray Co., Ltd.	RIOScan (RPS500)	2016-04-15

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004105475. Last updated year: 2026. Please use registration number 3004105475 when referencing this establishment in official correspondence.