Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3013734432

FEI Number

3013734432

Entity Name

FOSHAN SAFETY MEDICAL EQUIPMENT CO.,LTD.

City/State/Country

China Guangdong, CN

Establishment Address

Floor 1,2,3, Building 6-1, lane1, Dianbian East Road, Nanyue, Shangan, Danzao Town, Nanhai, Foshan City, Guan, China Guangdong 528223, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

FOSHAN SAFETY MEDICAL EQUIPMENT CO.,LTD. (Owner Number: 10090263)

Owner / Operator Contact Address

Floor 1,2,3, Building 6-1, lane1, Dianbian East Road, Nanyue, Shangan, Danzao Town, Nanhai, Foshan City, Guan, China, CN-GD 528223, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K231845

PMA Number

N/A

All Registered Proprietary Names

Dental Unit, Model: Mare Dental Unit, Model: Mare.1, Mare.2, Mare.3, Mare.4, Mare.5

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EIA	Unit, Operative Dental	Dental	Class 1	872.6640	2024-03-06

Official Correspondent

May Xian

US Agent Details

WINNIE Zhu Business: Umedwings Solution USA Email: Agent@Umedwings.Us Phone: (224) 4023150

Related Public Records

Same Entity

FOSHAN SAFETY MEDICAL EQUIPMENT 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 3013734432. Last updated year: 2026. Please use registration number 3013734432 when referencing this establishment in official correspondence.