Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3005524530

FEI Number

3005524530

Entity Name

Everfaith International (Shanghai) Ltd.

City/State/Country

Shanghai, CN

Establishment Address

Room F, 27th Floor, No. 58 Xin Jin Qiao Road, Shanghai 201206, CN

Establishment Type(s)

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

Owner / Operator

Everfaith International (Shanghai) Ltd. (Owner Number: 10060267)

Owner / Operator Contact Address

Room F, 27th Floor, No. 58 Xin Jin Qiao Road, Shanghai, CN-SH 201206, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Impervious Gown COHESIVE BANDAGE ADHESIVE BANDAGE Sponge Counter Bag Sponge Counter Glove ALCOHOL PREP PAD EMESIS BAG GAUZE Medicine Cup Pill Cutter, Pill Crusher

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LYU	Accessory, Surgical Apparel	General, Plastic Surgery	Class 1	878.4040	2020-08-21
FQM	Bandage, Elastic	General Hospital	Class 1	880.5075	2023-06-14
KGX	Tape And Bandage, Adhesive	General Hospital	Class 1	880.5240	2023-06-14
LWH	Counter, Sponge, Surgical	General Hospital	Class 1	880.2740	2019-04-19
LRJ	Disinfectant, Medical Devices	General Hospital	Class 1	880.6890	2023-06-14
FNY	Basin, Emesis	General Hospital	Class 1	880.6730	2024-03-14
NAB	Gauze / Sponge,Nonresorbable For External Use	General, Plastic Surgery	Class 1	878.4014	2023-06-14
KYW	Container, Liquid Medication, Graduated	General Hospital	Class 1	880.6430	2025-05-20
OHY	Pill Crusher/Cutter	General Hospital	Class 1	880.6430	2025-12-09

Official Correspondent

Daniel Chai

US Agent Details

Dan Prusha Business: Performance Health Email: dprusha@performancehealth.com Phone: (330) 6308585

Related Public Records

Same Entity

Everfaith International (Shanghai) 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

Registration Number	Establishment Name	Location
9680454	EMPRESAS IAI S DE RL DE C.V.	H. MATAMOROS Tamaulipas, MX
3010227982	Tianjin Zhengtian Medical Instrument Co., Ltd.	Tianjin, CN
3016871880	PRIMEX DESIGN & FABRICATION	Richmond, IN, US
3005360866	QEL DOMINICANA S.A.	ESPERANZA Valverde, DO
3010601984	Jiangsu Haize Medical Scientific Development Co.,Ltd.	Wuxi Jiangsu, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3005524530. Last updated year: 2026. Please use registration number 3005524530 when referencing this establishment in official correspondence.