Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3003749270

FEI Number

3003749270

Entity Name

WANDY RUBBER INDUSTRIAL CO., LTD

City/State/Country

New Taipei City, TW

Establishment Address

No. 48, Lane 392, Fu De 1st Road, Xi-Zhi District, New Taipei City 22150, TW

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Wandy Rubber Industrial Co., Ltd. (Owner Number: 9051017)

Owner / Operator Contact Address

No. 48, Lane 392, Fu De 1st Road, Xi-Zhi District, New Taipei City, TW-NOTA 22150, TW

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K121268

PMA Number

N/A

All Registered Proprietary Names

Wandy Self-Adhesive Electrodes WANDY Wandy Dispersive Electrode

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GXY	Electrode, Cutaneous	Neurology	Class 2	882.1320	2007-11-18
DRX	Electrode, Electrocardiograph	Cardiovascular	Class 2	870.2360	2026-03-19
GXY	Electrode, Cutaneous	Neurology	Class 2	882.1320	2014-01-02
DRX	Electrode, Electrocardiograph	Cardiovascular	Class 2	870.2360	2007-11-18
EGJ	Device, Iontophoresis, Other Uses	Physical Medicine	Class 2	890.5525	2012-06-06
ODR	Electrosurgical Patient Return Electrode	General, Plastic Surgery	Class 2	878.4400	2013-03-05

Official Correspondent

No official correspondent registered.

US Agent Details

David Lennarz Business: Registrar corp Email: David.Lennarz@registrarcorp.com Phone: (757) 2240177

Related Public Records

Same Entity

Wandy Rubber Industrial 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
K070612	Top-Rank Health Care Equipment Co., Ltd.	TOP-RANK ADHESIVE ELECTRODE	2007-05-07
K123915	Grass Technologies, an Astro-Med, Inc. Product Gro	DE48-PLUS	2013-04-24
K073532	Technomed Europe	DISPOSABLE ADHESIVE SURFACE ELECTRODES, DISC ELECTRODES	2008-05-01
K260363	Ceribell, Inc.	Ceribell Brain Monitor Headband	2026-04-03
K091762	Covidien	DURA-STICK SELF-ADHESIVE ELECTRODES WITH ALOE	2009-12-22

Similar Registrations

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3004695199	INCEREB LTD	Dublin Dun Laoghaire-Rathdown, IE
3005581220	SPES MEDICA S.P.A	BATTIPAGLIA Salerno, IT
9616086	DJ ORTHOPEDICS DE MEXICO, S.A. DE C.V.	TIJUANA Baja California, MX

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3003749270. Last updated year: 2026. Please use registration number 3003749270 when referencing this establishment in official correspondence.