Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010625818

FEI Number

3010625818

Entity Name

SUZHOU BAILI MEDICAL SUPPLIES CO.,LTD

City/State/Country

Suzhou Jiangsu, CN

Establishment Address

No.68 Donggu Road,Qiushe District,Tongli Town, Suzhou Jiangsu 215216, CN

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Suzhou Baili Medical Supplies Co.,Ltd (Owner Number: 10045746)

Owner / Operator Contact Address

No.68 Donggu Road,Qiushe District,Tongli Town, Suzhou, CN-JS 215211, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Pad Cover Armboard Cover COVER, SHOE, OPERATING-ROOM, Baili Shoe Cover FIBER, MEDICAL, ABSORBENT

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FMW	Cover, Mattress (Medical Purposes)	General Hospital	Class 1	880.6190	2019-11-19
BWN	Table And Attachments, Operating-Room	General, Plastic Surgery	Class 1	878.4950	2017-03-07
FXP	Cover, Shoe, Operating-Room	General, Plastic Surgery	Class 1	878.4040	2013-12-23
CCX	Support, Patient Position	Anesthesiology	Class 1	868.6820	2017-03-15
FRL	Fiber, Medical, Absorbent	General Hospital	Class 1	880.5300	2021-12-22
FYA	Gown, Surgical	General, Plastic Surgery	Class 2	878.4040	2013-12-23

Official Correspondent

Selina Zhang

US Agent Details

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

Related Public Records

Same Entity

Suzhou Baili Medical Supplies 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
K812396	Northwest Surgical Concepts, Inc.	ARTHRO-PREP REST	1981-11-20
K892118	Paramount Products, Inc.	NON-STERILE MASKS AND CAPS	1989-04-20

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010625818. Last updated year: 2026. Please use registration number 3010625818 when referencing this establishment in official correspondence.