Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3016099036

FEI Number

3016099036

Entity Name

New Deantronics Taiwan Ltd. - Chiayi

City/State/Country

Chiayi County, TW

Establishment Address

No. 16, Machouhou Yuancyu 1st Rd., Lucao Township, Chiayi County 611, TW

Establishment Type(s)

Sterilize Medical Device for Another Party (Contract Sterilizer)

Owner / Operator

NEW DEANTRONICS TAIWAN LTD. (Owner Number: 9020358)

Owner / Operator Contact Address

12F. No.51, Sec. 4, Zhongyang Rd., Tucheng Dist., New Taipei City, TW-NOTA 236, TW

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Neuroblade System disposable handswitch pencil electrosurgical cutting and coagulation accessories Hawkeye Control Unit with Eyas Endoscope

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2024-04-18
GWG	Endoscope, Neurological	Neurology	Class 2	882.1480	2024-04-18
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2018-12-10
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2016-10-27
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2013-01-07
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2023-09-14
HRX	Arthroscope	Orthopedic	Class 2	888.1100	2025-06-23

Official Correspondent

No official correspondent registered.

US Agent Details

TINA LO Business: New Deantronics, Ltd. Email: tina.lo@newdean.com Phone: (775) 4331808

Related Public Records

Same Entity

NEW DEANTRONICS TAIWAN LTD.

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
9681191	NEW DEANTRONICS TAIWAN LTD.	New Taipei City, TW

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K970809	Somnus Medical Technologies, Inc.	BENDABLE TISSUE COAGULATING ELECTRODE WITH BENDING TOOL	1997-06-18
K222793	C.R. Bard, Inc.	WavelinQ Generator	2022-10-17
K002257	Tecno Instruments (Pvt.) , Ltd.	TECNO DISPOSABLE FINGERSWITCH PENCIL, MODEL 150-100	2000-10-19
K193591	Bowa-Electronics GmbH & Co. KG	ARC 400	2020-04-02
K192128	Sutter Medizintechnik GmbH	Sutter Arrowtip Monopolar Electrodes	2019-10-04

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0031-06	Rita Medical Systems	2	Rita Brand Habib 4X Electrosurgical Coagulator, Catalog Number: 4401US; Product is distributed by RITA Medical Systems, Inc., One Horizon Way. Manchester, GA 32826
Z-0041-05	Linvatec Corp.	2	Ultra Power Burs, Sterile, Single-Use.

Similar Registrations

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3020623326	TRIWORKS GROUP S.R.L.	Palata Campobasso, IT
3012616488	BRERA MEDICAL INCORPORATED	Northborough, MA, US
3012940012	Sutter Medical Technologies USA Inc.	Alpharetta, GA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3016099036. Last updated year: 2026. Please use registration number 3016099036 when referencing this establishment in official correspondence.