Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3034170504

FEI Number

3034170504

Entity Name

ZHONG SHAN FIRST CITY LEATHER PRODUCTS CO., LTD.

City/State/Country

Zhongshan City Guangdong, CN

Establishment Address

No. 16, Nanyuan Road, South District, Zhongshan City Guangdong 528400, CN

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Zhong Shan First City Leather Products Co., Ltd. (Owner Number: 10092194)

Owner / Operator Contact Address

No. 16, Nanyuan Road, South District, Zhongshan City, CN-GD 528400, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Nucleus® 24 Cochlear Implant System

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MCM	Implant, Cochlear	Unknown	Class 3	N/A	2024-12-12

Official Correspondent

Jui Hsin Chen

US Agent Details

Shu-Chen Cheng Business: ROC Chinese-European Industrial Research Society Email: ceirs.jen@msa.hinet.net Phone: (614) 5888168

Related Public Records

Same Entity

Zhong Shan First City Leather Products Co., Ltd.

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

View Entity Profile →

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0003-2012	Cochlear Americas Inc.	3	Cochlear Nucleus CI512 Cochlear Implant, REF Z209051, New with Nucleus 5, Sterile EO, Made in Australia, Cochlear Ltd 14 Mars Road, Lane Cove 2066, Australia. The cochlear implant is intended to restore a level of auditory sensation via the electrical stimulation of the auditory nerve.
Z-0044-05	Advanced Bionics	3	Advanced Bionics implantable cochlear stimulator CLARION 1.2 Models AB-5100L AB-5100R AB-5100ML/R (For Export Only) AB-5100H AB-5100H-01A

Similar Registrations

Registration Number	Establishment Name	Location
3009762645	Advanced Bionics LLC	Valencia, CA, US
9611813	CHRISTIAN DIENER GMBH	TUTTLINGEN Baden-Wurttemberg, DE
3013177549	Cochlear Malaysia Sdn Bhd	Kuala Lumpur Kuala Lumpur, MY
3009092818	Cochlear Ltd	Macquarie University New South Wales, AU
9613646	Cochlear Limited - Brisbane	Newstead Queensland, AU

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3034170504. Last updated year: 2026. Please use registration number 3034170504 when referencing this establishment in official correspondence.