Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3004704697

FEI Number

3004704697

Entity Name

CAREMAX CO., LTD.

City/State/Country

SUZHOU, JIANGSU PROVINCE, CN

Establishment Address

NO. 43 SHUANGJING STREET, FENG TING ROAD, SUZHOU, JIANGSU PROVINCE 215121, CN

Establishment Type(s)

Repack or Relabel Medical Device,Export Device to the United States But Perform No Other Operation on Device,Manufacture Medical Device,Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

CAREMAX CO., LTD. (Owner Number: 9065435)

Owner / Operator Contact Address

NO. 43 SHUANGJING STREET, FENG TING ROAD, SUZHOU, JIANGSU PROVINCE, CN-NOTA 215121, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Alcohol Prep Pads Compression Dressing Tweezers, plastic Medical Scissors, Disposable NITRILE PATIENT EXAMINATION GLOVES ARM SLING, TRIANGULAR BANDAGE, MULT Gauze Sponge Vinyl Examination Gloves Adhesive Bandages Adhesive Strips KIT, FIRST AID (MULTIPLE BRANDS) POWDER FREE NITRILE PATIENT EXAMINATION GLOVES Mask, surgical DISPOSABLE BEDDING FIBER, MEDICAL, ABSORBENT TRAUMA DRESSING, ROLLED GAUZE BANDA

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LKB	Pad, Alcohol, Device Disinfectant	Unknown	Class U	N/A	2020-05-29
MHW	Dressing, Compression	General Hospital	Class 1	880.5075	2015-04-22
HTD	Forceps	General, Plastic Surgery	Class 1	878.4800	2012-07-11
JOK	Scissors, Medical, Disposable	General Hospital	Class 1	880.6820	2017-03-29
OPJ	Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs	General Hospital	Class 1	880.6250	2023-12-08
LZC	Medical Glove, Specialty	General Hospital	Class 1	880.6250	2023-12-08
QDO	Fentanyl And Other Opioid Protection Glove	General Hospital	Class 1	880.6250	2023-12-08
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2023-12-08
ILI	Sling, Arm	Physical Medicine	Class 1	890.3640	2007-11-07
NAB	Gauze / Sponge,Nonresorbable For External Use	General, Plastic Surgery	Class 1	878.4014	2008-03-28
LYZ	Vinyl Patient Examination Glove	General Hospital	Class 1	880.6250	2020-12-07
KGX	Tape And Bandage, Adhesive	General Hospital	Class 1	880.5240	2007-11-07
LRR	First Aid Kit With Drug	Unknown	Class N	N/A	2007-11-07
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2023-12-08
FXX	Mask, Surgical	General, Plastic Surgery	Class 2	878.4040	2022-11-29
KME	Bedding, Disposable, Medical	General Hospital	Class 1	880.6060	2007-11-07
FRL	Fiber, Medical, Absorbent	General Hospital	Class 1	880.5300	2007-11-07

Official Correspondent

No official correspondent registered.

US Agent Details

Jon Ward Business: AJW Technology Consultants, Inc. Email: usagent@ajwtech.com Phone: (813) 6452855

Related Public Records

Same Entity

CAREMAX 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
K852723	The Huxley Instrument Corp.	FOERSTER SPONGE FORCEPS, SERRATED, 7+SS 410 OR 420	1985-07-15
K873512	Arthropedics, Inc.	SERRATED GRASPING FORCEPS, RIGHT	1987-11-02
K212801	Hong Seng Gloves Sdn Bhd	Powder free nitrile examination glove- black, non sterile	2022-01-09
K260806	Vista Industries,, LLC	Nitrile Disposable Examination Gloves	2026-06-03
K011593	Ansell Healthcare Products, Inc.	MICRO-TOUCH NITRILE POWDER FREE SYNTHETIC MEDICAL EXAMINATION GLOVES, COLOR BLUE NON-STERILE	2001-06-21

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004704697. Last updated year: 2026. Please use registration number 3004704697 when referencing this establishment in official correspondence.