Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3015214015

FEI Number

3015214015

Entity Name

SUZHOU DYNAREX CO., LTD

City/State/Country

Suzhou Jiangsu, CN

Establishment Address

Room 2407, BLD 1, Mintianxiang International Mansion, No.318 Suya Road, Suzhou Industrial Park, China (Jiangsu) Free Trade Experimental Zone Suzhou District, Suzhou Jiangsu 215021, CN

Establishment Type(s)

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

Owner / Operator

Suzhou DYNAREX Co., Ltd (Owner Number: 10080407)

Owner / Operator Contact Address

Room 2407, BLD 1, Mintianxiang International Mansion, No.318 Suya Road, Suzhou Industrial Park, China (Jiangsu) Free Trade Experimental Zone Suzhou District, Suzhou, CN-JS 215021, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Cotton Ball Emergency Blanket Compressed krinkle gauze roll COTTON BALL Triangular Bandage Gauze Bandage, Bandage Elastic EMERGENCY OBSTETRICAL KIT

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FRL	Fiber, Medical, Absorbent	General Hospital	Class 1	880.5300	2021-01-30
KME	Bedding, Disposable, Medical	General Hospital	Class 1	880.6060	2021-03-02
NAB	Gauze / Sponge,Nonresorbable For External Use	General, Plastic Surgery	Class 1	878.4014	2021-03-07
EFN	Cotton, Roll	Dental	Class 1	872.6050	2021-03-02
ILI	Sling, Arm	Physical Medicine	Class 1	890.3640	2021-03-02
FQM	Bandage, Elastic	General Hospital	Class 1	880.5075	2021-03-02
OKU	Emergency Obstetrical Kit	Obstetrics/Gynecology	Class 1	884.4520	2021-03-02

Official Correspondent

Charles Shen

US Agent Details

Charles Shen Business: Manton Business and Technology Services Email: cyshen@aol.com Phone: (608) 2179358

Related Public Records

Same Entity

Suzhou DYNAREX Co., Ltd

View consolidated registration, premarket clearance, and recall records for this applicant.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3015214015. Last updated year: 2026. Please use registration number 3015214015 when referencing this establishment in official correspondence.