Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3025330366

FEI Number

3025330366

Entity Name

SIGKNOW BIOMEDICAL CO., LTD.

City/State/Country

Taipei City, TW

Establishment Address

10F. -2, No. 760, Sec. 4, Bade Road, Songshan District, Taipei City 105, TW

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Sigknow Biomedical Co., Ltd. (Owner Number: 10086189)

Owner / Operator Contact Address

10F.-2, No. 760, Sec. 4, Bade Road, Songshan District, Taipei City, TW-TPE 105, TW

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K213233

PMA Number

N/A

All Registered Proprietary Names

EZYPRO ECG Recorder

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DRG	Transmitters And Receivers, Physiological Signal, Radiofrequency	Cardiovascular	Class 2	870.2910	2022-10-20

Official Correspondent

Alan Wu

US Agent Details

Marissa Vilchez Email: m.vilchez@mdssar.com Phone: (312) 9751694

Related Public Records

Same Entity

Sigknow Biomedical Co., Ltd.

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
K131913	Philips Medizin Systeme Boeblingen GmbH	INTELLIVUE CL SPO2 POD AND CL NBP POD, PHILIPS INTELLIVUE PATIENT MONITORS MP5, MP5T, MP5SC	2013-11-26

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3016595211	DYNAMIC EMS LTD	Dalgety Bay Fife, GB
3012302888	QUIPMENT INC.	Kennesaw, GA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3025330366. Last updated year: 2026. Please use registration number 3025330366 when referencing this establishment in official correspondence.