Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010375076

FEI Number

3010375076

Entity Name

Shandong Chengsheng Healthcare Products co.,Ltd

City/State/Country

Weifang Shandong, CN

Establishment Address

No.2727 Shimen Road, Chengguan Street, Linqu County, Weifang Shandong 261000, CN

Establishment Type(s)

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

Owner / Operator

Shandong Chengsheng Healthcare Products co.,Ltd (Owner Number: 10043655)

Owner / Operator Contact Address

No.2727 Shimen Road, Chengguan Street, Linqu County, Weifang, CN-SD 261000, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Non-adherent pad Brief Liner Moderate Pad Non-woven Sponge Drape, surgical, exempt

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MSH	Respirator, Surgical	General, Plastic Surgery	Class 2	878.4040	2020-04-03
NAC	Dressing, Wound, Hydrophilic	General, Plastic Surgery	Class 1	878.4018	2024-01-28
EYQ	Garment, Protective, For Incontinence	Gastroenterology, Urology	Class 1	876.5920	2016-05-09
FRL	Fiber, Medical, Absorbent	General Hospital	Class 1	880.5300	2024-01-28
PUI	Drape, Surgical, Exempt	General, Plastic Surgery	Class 2	878.4370	2024-08-20
KHA	Mask, Scavenging	Anesthesiology	Class 1	868.5590	2020-03-20
OEA	Non-Surgical Gown	General, Plastic Surgery	Class 1	878.4040	2020-06-04

Official Correspondent

Chen Ming Yang

US Agent Details

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

Related Public Records

Same Entity

Shandong Chengsheng Healthcare Products 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
K102092	Prestige Ameritech	PRO GEAR N95 PARTICULATE FILTER RESPIRATOR & SURGICAL MASK, REGULAR SIZE MODEL RP CERIES	2010-10-06

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3041850200	RISKWISE SUPPLIES LLC	Lorton, VA, US
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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010375076. Last updated year: 2026. Please use registration number 3010375076 when referencing this establishment in official correspondence.