Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3011260488

FEI Number

3011260488

Entity Name

GERUI MEDICAL PRODUCTS CO LTD

City/State/Country

Changzhou Jiangsu, CN

Establishment Address

No.209 Gounan Road, Huadu Industrial Zone, Lijia Town, Wujin District, Changzhou Jiangsu 213173, CN

Establishment Type(s)

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

Owner / Operator

GERUI Medical Products Co Ltd (Owner Number: 10047973)

Owner / Operator Contact Address

No.209 Gounan Road, Huadu Industrial Zone, Lijia Town, Wujin District, Changzhou, CN-JS 213173, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Razor, Surgical Clamp Pill Crusher/Cutter Rubber Tip Nose Clip Clip Nose-Foam Nose Clips CONTAINER, SPECIMEN,NON-STERILE,Triangl Graduate

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LWK	Razor, Surgical	General, Plastic Surgery	Class 1	878.4800	2014-11-20
HXD	Clamp	General, Plastic Surgery	Class 1	878.4800	2014-11-20
OHY	Pill Crusher/Cutter	General Hospital	Class 1	880.6430	2014-11-20
BXJ	Clip, Nose	Anesthesiology	Class 1	868.6225	2017-05-10
NNI	Container, Specimen, Non-Sterile	Pathology	Class 1	864.3250	2014-11-20

Official Correspondent

No official correspondent registered.

US Agent Details

Charles Mack Business: IRC USA Email: ircfda@gmail.com Phone: (931) 6254938

Related Public Records

Same Entity

GERUI Medical Products 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 3011260488. Last updated year: 2026. Please use registration number 3011260488 when referencing this establishment in official correspondence.