Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3013547614

FEI Number

3013547614

Entity Name

ANQING JIAXIN MEDICAL TECHNOLOGY CO., LTD.

City/State/Country

Anqing Anhui, CN

Establishment Address

No. 13 Jing Road, Daqiao Economic Development Zone, Anqing Anhui 246000, CN

Establishment Type(s)

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

Owner / Operator

Anqing Jiaxin Medical Technology Co., Ltd. (Owner Number: 10054839)

Owner / Operator Contact Address

No. 13 Jing Road, Daqiao Economic Development Zone, Anqing, CN-AH 246000, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Disposable bed sheet Face Mask ALCOHOL PREP PAD Cotton pad Velcro, Adhesive Tape APPLICATOR, ABSORBENT TIPPED Face Mask Gauze Medical Cotton Ball

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KME	Bedding, Disposable, Medical	General Hospital	Class 1	880.6060	2023-01-02
QKR	Face Mask Within The Scope Of The Face Mask And Barrier Face Covering Enforcement Policy Or Face Mask Umbrella Eua	Unknown	Class N	N/A	2020-04-14
LRJ	Disinfectant, Medical Devices	General Hospital	Class 1	880.6890	2024-09-23
FRL	Fiber, Medical, Absorbent	General Hospital	Class 1	880.5300	2023-01-02
KGX	Tape And Bandage, Adhesive	General Hospital	Class 1	880.5240	2023-06-08
KXF	Applicator, Absorbent Tipped, Non-Sterile	General Hospital	Class 1	880.6025	2017-05-02
KHA	Mask, Scavenging	Anesthesiology	Class 1	868.5590	2020-03-23
NAB	Gauze / Sponge,Nonresorbable For External Use	General, Plastic Surgery	Class 1	878.4014	2021-05-09
EFN	Cotton, Roll	Dental	Class 1	872.6050	2023-01-03

Official Correspondent

Charles Shen

US Agent Details

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

Related Public Records

Same Entity

Anqing Jiaxin Medical Technology 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

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3013547614. Last updated year: 2026. Please use registration number 3013547614 when referencing this establishment in official correspondence.