Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3017889703

FEI Number

3017889703

Entity Name

COMPAI HEALTHCARE (SUZHOU) CO.,LTD

City/State/Country

Suzhou Jiangsu, CN

Establishment Address

Room 3A05, Building 2, No.8 Changting Road,High-tech Zone, Suzhou, Jiangsu, P.R. China, Suzhou Jiangsu 215151, CN

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

CompAI Healthcare (Suzhou) Co.,ltd (Owner Number: 10086645)

Owner / Operator Contact Address

Room 3A05, Building 2, No.8 Changting Road,High-tech Zone, Suzhou, Jiangsu, P.R. China, Suzhou, CN-JS 215151, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

TrueView 200 Pro-US TureView 100 Pro QuadraView 100

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MWP	Cabinet, X-Ray System	Radiology	Class 2	892.1680	2023-04-25
MWP	Cabinet, X-Ray System	Radiology	Class 2	892.1680	2022-12-19
NNI	Container, Specimen, Non-Sterile	Pathology	Class 1	864.3250	2022-12-21

Official Correspondent

Sheng Peng

US Agent Details

Emre Toker Email: toker@comp-ai.com Phone: (520) 2415559

Related Public Records

Same Entity

CompAI Healthcare (Suzhou) Co.,ltd

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

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3017889703. Last updated year: 2026. Please use registration number 3017889703 when referencing this establishment in official correspondence.