Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3014059828

FEI Number

3014059828

Entity Name

SHANGHAI EDER MEDICAL TECHNOLOGY INC.

City/State/Country

Shanghai, CN

Establishment Address

Room430, Building4, No.512 Wenchuan Road, Baoshan District, Shanghai 200433, CN

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device,Manufacture Medical Device

Owner / Operator

Shanghai Eder Medical Technology Inc. (Owner Number: 10056006)

Owner / Operator Contact Address

Room430, Building4, No.512 Wenchuan Road, Baoshan District, Shanghai, CN-SH 200433, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

SURGICAL MICROSCOPE(model:EM-300), SM 1000 L, SM 3000 L, EM 600 B, SM 2000 J, EM 600 A, SM 2000 L, SM 1000 L/P Stereo Optical Inverter, Stereo Indirect Ophthalmoscope

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FSO	Microscope, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4700	2017-10-26

Official Correspondent

Yilun Zheng

US Agent Details

Leeyeo Kee Business: Regrek LLC Email: regrek.cs@hotmail.com Phone: (302) 6089028

Related Public Records

Same Entity

Shanghai Eder Medical Technology Inc.

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 3014059828. Last updated year: 2026. Please use registration number 3014059828 when referencing this establishment in official correspondence.