Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3025360949

FEI Number

3025360949

Entity Name

SUZHOU HEALTHLINE MEDICAL CO.,LTD.

City/State/Country

Suzhou Jiangsu, CN

Establishment Address

Building No 5, No. 46, Linjiang Road, Industrial Park, Suzhou Jiangsu 215120, CN

Establishment Type(s)

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

Suzhou Healthline Medical Co.,Ltd. (Owner Number: 10086157)

Owner / Operator Contact Address

Building No 5, No. 46, Linjiang Road, Industrial Park, Suzhou, CN-JS 215120, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Cohesive elastic bandage, Elastic Adhesive Bandage, Adhesive Sport bandage, Elastic Bandage Medical Adhesive Tape, Kinesiology Tape Non-woven dressing, Foam dressing, Adhesive Bandage

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FQM	Bandage, Elastic	General Hospital	Class 1	880.5075	2022-10-19
KGX	Tape And Bandage, Adhesive	General Hospital	Class 1	880.5240	2022-10-19
MHW	Dressing, Compression	General Hospital	Class 1	880.5075	2022-10-19

Official Correspondent

Gong Chen

US Agent Details

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

Related Public Records

Same Entity

Suzhou Healthline Medical 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
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

Similar Registrations

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3005423373	TRI-FI KNITTING, LLC	Dunlap, TN, US
3008973900	SAFECARE MEDICAL PRODUCTS CO., LTD. (HEFEI)	HEFEI Anhui, CN
3005360866	QEL DOMINICANA S.A.	ESPERANZA Valverde, DO
3015414796	COMPRESS INNOVATIONS, LLC	Manhasset, NY, US
3004651767	CLEARPOINT MEDICAL	Lachine Quebec, CA

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3025360949. Last updated year: 2026. Please use registration number 3025360949 when referencing this establishment in official correspondence.