Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3016730274

FEI Number

3016730274

Entity Name

SHANGHAI EA MEDICAL INSTRUMENTS CO., LTD.

City/State/Country

Yangpu District Shanghai, CN

Establishment Address

Room 601-603, No. 500, Zhengli Road, Yangpu District Shanghai 201615, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Shanghai EA Medical Instruments Co., Ltd. (Owner Number: 10089566)

Owner / Operator Contact Address

No.500 Zhengli Road, Shanghai, CN-SH 200433, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K223518

PMA Number

N/A

All Registered Proprietary Names

No proprietary names listed under this establishment.

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
PNN	Orthodontic Software	Dental	Class 2	872.5470	2023-12-18

Official Correspondent

Jessica Luo

US Agent Details

Bill Jacqmein Email: bjacqmein@primepathmedtech.com Phone: (404) 2166190

Related Public Records

Same Entity

Shanghai EA Medical Instruments 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 3016730274. Last updated year: 2026. Please use registration number 3016730274 when referencing this establishment in official correspondence.