Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3016608162

FEI Number

3016608162

Entity Name

GUANGZHOU FAME MEDICAL CO., LTD.

City/State/Country

Guangzhou Guangdong, CN

Establishment Address

Second Floor A No.8, Lianhua Port Industrial Zone, Lotus Mountain Bonded Area, Shilou Town, Panyu District, Guangzhou Guangdong 511440, CN

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Guangzhou Fame Medical Co., Ltd. (Owner Number: 10093833)

Owner / Operator Contact Address

Second Floor A No.8, Lianhua Port Industrial Zone, Lotus Mountain Bonded Area, Shilou Town, Panyu District, Guangzhou, CN-GD 511440, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

EvaCare® Pessaries

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HHW	Pessary, Vaginal	Obstetrics/Gynecology	Class 2	884.3575	2025-07-18

Official Correspondent

Emily Chen

US Agent Details

Timothy Young Business: Personal Medical Corp. Email: tyoung@personalmed.com Phone: (425) 2426373

Related Public Records

Same Entity

Guangzhou Fame Medical 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
K933654	Johnson & Johnson Medical, Inc.	BLADDER NECK SUPPORT PROTHESIS FITTING KIT	1995-05-04

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3016608162. Last updated year: 2026. Please use registration number 3016608162 when referencing this establishment in official correspondence.