Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3008114669

FEI Number

3008114669

Entity Name

PRINTEC H.T. ELECTRONICS CORP.

City/State/Country

New Taipei City 235, Taiwan (R.O.C.), TW

Establishment Address

No.38, Liyan St., Zhonghe Dist., No.38, Liyan St., Zhonghe Dist., New Taipei City 235, Taiwan (R.O.C.) 23357, TW

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

PRINTEC H.T. ELECTRONICS CORP. (Owner Number: 10043782)

Owner / Operator Contact Address

No.38, Liyan St., Zhonghe Dist., New Taipei City 235, Taiwan (R.O.C.), TW-TPE 23357, TW

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

No proprietary names listed under this establishment.

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	2023-03-21
DRX	Electrode, Electrocardiograph	Cardiovascular	Class 2	870.2360	2018-12-22
IKD	Cable, Electrode	Physical Medicine	Class 2	890.1175	2024-11-05

Official Correspondent

Charlie Chang

US Agent Details

Dan Anderson Business: SSI ELECTRONICS, INC. Email: dana@ssi-electronics.com Phone: (616) 8668880

Related Public Records

Same Entity

PRINTEC H.T. ELECTRONICS CORP.

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
K934333	3M Medical Products Group	3M RED DOT 2237 STICKY GEL MONITORING ECG ELECTRODE	1994-07-07

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3038761440	Corsano Health SA	Plan-les-Ouates Geneve, CH
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 3008114669. Last updated year: 2026. Please use registration number 3008114669 when referencing this establishment in official correspondence.