Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3027496319

FEI Number

3027496319

Entity Name

COMPASS BIOINFORMATICS INC.

City/State/Country

Hsinchu City Hsinchu (City), TW

Establishment Address

17 F.-10, No. 118, Ciyun Rd.,, Puding Vil., East Dist.,, Hsinchu City Hsinchu (City) 30072, TW

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

COMPASS BIOINFORMATICS INC. (Owner Number: 10087881)

Owner / Operator Contact Address

17 F.-10, No. 118, Ciyun Rd.,, Puding Vil., East Dist.,, Hsinchu City, TW-HSZ 30072, TW

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

InheriNext

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
JQP	Calculator/Data Processing Module, For Clinical Use	Clinical Chemistry	Class 1	862.2100	2023-04-25

Official Correspondent

Ping Cheng Hsiung

US Agent Details

Daniel Chen Email: danchen@arbelosdx.com Phone: (626) 4638162

Related Public Records

Same Entity

COMPASS BIOINFORMATICS 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
K781173	Instrumentation Laboratory CO	COMPUTER INTERFACE IL 814	1978-09-14

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0007-04	Misys Healthcare Systems	1	Calculator/Data Processing Module for Clinical Use
Z-0026-2025	Becton Dickinson & Co.	1	BD Synapsys Informatics Solution with software versions: 4.20, 4.30, 5.10, 5.20 and 5.30- IVD standalone laboratory software solution providing data management and workflow management functionality across locations where clinical diagnostic activities take place. Catalog Number: 444150

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3027496319. Last updated year: 2026. Please use registration number 3027496319 when referencing this establishment in official correspondence.