Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3009201600

FEI Number

3009201600

Entity Name

SHENZHEN GOLDCARE MEDITECH CO., LTD.

City/State/Country

Shenzhen Guangdong, CN

Establishment Address

902, Building C, Jinweiyuan Industrial Park, 41 Qingsong Road, Zhukeng Community, Longtian Street, Pingshan District, Shenzhen, China, Shenzhen Guangdong 518118, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Shenzhen GoldCare Meditech Co., Ltd. (Owner Number: 10045780)

Owner / Operator Contact Address

902, Building C, Jinweiyuan Industrial Park, 41 Qingsong Road, Zhukeng Community, Longtian Street, Pingshan District, Shenzhen, CN-GD 518118, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

AL-106, AL-106SA AND AL-106B MEDGYN DIGITAL VIDEO COLPOSCOPE GC-8000E Digital Video Colposcope GC-5000E Digital Video Colposcope G9 Digital Video Colposcope GC-3000E Digital Video Colposcope

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HEX	Colposcope (And Colpomicroscope)	Obstetrics/Gynecology	Class 2	884.1630	2016-06-15
PTZ	Colposcope (And Colpomicroscope), Exempt	Obstetrics/Gynecology	Class 2	884.1630	2025-01-13

Official Correspondent

Liyan Zhong

US Agent Details

Amar Agadi Business: Amar Plastics,Inc. Email: amar@medgyn.com Phone: (630) 9257446

Related Public Records

Same Entity

Shenzhen GoldCare Meditech Co., Ltd.

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

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009201600. Last updated year: 2026. Please use registration number 3009201600 when referencing this establishment in official correspondence.