Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3013039893

FEI Number

3013039893

Entity Name

SHANGHAI HANDY MEDICAL EQUIPMENT CO., LTD.

City/State/Country

Shanghai, CN

Establishment Address

Bldg No.11, Lane 177, Fulian Er Road, Baoshan District, Shanghai 201906, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Shanghai Handy Medical Equipment Co., Ltd. (Owner Number: 10054306)

Owner / Operator Contact Address

Bldg No.11, Lane 177, Fulian Er Road, Baoshan District, Shanghai, CN-SH 201906, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

HDR-461 HDR-361 HDR Sensor HDI-210, HDI-200A, HDI-220D, HDI-220DA, HDI-712C. HDI-712D Intraroral Camera

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MUH	System, X-Ray, Extraoral Source, Digital	Dental	Class 2	872.1800	2022-06-24
NRD	Unit, Operative Dental, Accessories	Dental	Class 1	872.6640	2020-12-04

Official Correspondent

Marcia Qiu

US Agent Details

Lee Strong Business: 510K FDA Inc. Email: lee@510kfda.com Phone: (386) 5068711

Related Public Records

Same Entity

Shanghai Handy Medical Equipment 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
K221008	Shanghai Handy Medical Equipment Co., Ltd.	HDR Sensor- HDR361 (Size 1), HDR Sensor- HDR461 (Size 2)	2022-06-22
K160788	Ray Co., Ltd.	RIOScan (RPS500)	2016-04-15

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3013039893. Last updated year: 2026. Please use registration number 3013039893 when referencing this establishment in official correspondence.