Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3021595883

FEI Number

3021595883

Entity Name

XIAMEN MK HEALTH CARE PRODUCT CO., LTD.

City/State/Country

XIAMEN Fujian, CN

Establishment Address

UNIT 704, DFC(DINGFENG FINANCIAL CENTER), NO.503 GAOLIN MIDDLE ROAD, HULI DISTRICT, XIAMEN Fujian 361000, CN

Establishment Type(s)

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

Owner / Operator

XIAMEN MK HEALTH CARE PRODUCT CO., LTD. (Owner Number: 10083804)

Owner / Operator Contact Address

UNIT 704, DFC(DINGFENG FINANCIAL CENTER), NO.503 GAOLIN MIDDLE ROAD, HULI DISTRICT, XIAMEN, CN-FJ 361000, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

TISSUE PAPER, BIODEGRADABLE NONWOVEN FABRIC, WET WIPE BABY DIAPER, ADULT DIAPER, PET DIAPER Incontinence Pad Diaper Booster Pad BIODEGRADABLE PLASTIC FILM Silicone coated paper

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LNW	Paper, Obstetric Ph	Clinical Chemistry	Class 1	862.1550	2021-12-21
EYQ	Garment, Protective, For Incontinence	Gastroenterology, Urology	Class 1	876.5920	2021-12-21
OOD	Surgical Film	General, Plastic Surgery	Class 2	878.3300	2021-12-21
DSF	Recorder, Paper Chart	Cardiovascular	Class 1	870.2810	2024-11-03

Official Correspondent

Helen Cai

US Agent Details

Emilie Davis Email: safjiofewiwds@wilson.ntesmail.com Phone: (818) 5797288

Related Public Records

Same Entity

XIAMEN MK HEALTH CARE PRODUCT 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
K770946	Instrumentation Laboratory CO	RECORD, MODEL 702, I.L.	1977-07-05

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0027-04	Instrumentation Laboratory Co.	1	Lactate Disposable Membrane Caps Product Number: 0018108400

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3016621374	Jiangsu Medomics Medical Technology Co., Ltd.	Nanjing Jiangsu, CN
3025041446	2SAN LLC	New York, NY, US
3005630901	FridaBaby LLC	Miami, FL, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3021595883. Last updated year: 2026. Please use registration number 3021595883 when referencing this establishment in official correspondence.