Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3012430011

FEI Number

3012430011

Entity Name

CAREMAX SHANGHAI COMPANY LIMITED

City/State/Country

SHANGHAI, CN

Establishment Address

RM401, BULIDING NO. 5, NO. 3295 YAN/AN XI ROAD, SHANGHAI 200336, CN

Establishment Type(s)

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

Owner / Operator

CAREMAX SHANGHAI COMPANY LIMITED (Owner Number: 10050140)

Owner / Operator Contact Address

RM401, BULIDING NO. 5, NO. 3295 YAN/AN XI ROAD, SHANGHAI, CN-SH 200336, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Tape strip Sheet Paper Surgical Drape Isolation Gown, non-surgical Clean up tray Endo transport pad Cleaning brush Clean up bag Cover, Endo Sleeve

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KGX	Tape And Bandage, Adhesive	General Hospital	Class 1	880.5240	2016-12-13
KME	Bedding, Disposable, Medical	General Hospital	Class 1	880.6060	2022-12-05
PUI	Drape, Surgical, Exempt	General, Plastic Surgery	Class 2	878.4370	2018-04-03
OEA	Non-Surgical Gown	General, Plastic Surgery	Class 1	878.4040	2020-03-26
MNL	Accessories, Cleaning Brushes, For Endoscope	Gastroenterology, Urology	Class 1	876.1500	2017-02-10

Official Correspondent

Ivy Sun

US Agent Details

Julia Huang Email: julia.huang@gmaxind.com Phone: (631) 9531268

Related Public Records

Same Entity

CAREMAX SHANGHAI COMPANY LIMITED

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
K843874	Beiersdorf, Inc.	LEUKOPOR SURGICAL TAPE	1985-02-21
K915446	Sun Glitz Corp.	STRETCH WRAP	1992-05-06
K833120	Acme United Corp.	ONE TIME COMPOUND BENZOIN TINCTURE-	1983-12-29
K870091	Avery Intl.	IV SECUREMENT DEVICE USING PCCE THERMO. FILM	1987-02-04

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3012453673	FANNIN (UK) LIMITED	Measham, Swadlincote Derbyshire, GB
3019843433	The Natural Patch Company Pty Ltd	Prahran Victoria, AU

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3012430011. Last updated year: 2026. Please use registration number 3012430011 when referencing this establishment in official correspondence.