Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3013823570

FEI Number

3013823570

Entity Name

GUANGZHOU BAOLI HARDWARE & ELECTRONIC CO.,LTD.

City/State/Country

Guangzhou Guangdong, CN

Establishment Address

Zhongyi Industrial Park,Zhongcun Town,Panyu Dristrict, Guangzhou Guangdong 511495, CN

Establishment Type(s)

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

Owner / Operator

Guangzhou Baoli Hardware & Electronic CO.,LTD. (Owner Number: 10060897)

Owner / Operator Contact Address

Zhongyi Industrial Park,Zhongcun Town,Panyu Dristrict, Guangzhou, CN-GD 511495, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Disposable protective foot cover Walking Cane AH03, AH04 Foldable Walking Cane AH02, AH12 Elbow crutch AH05 Stand-up Walking Cane AH08 Safety 1st(Alcohol wipes) Fix-Type Folding Bed Rail: AR04 U Relyon Steady Bed Rail: AR01 Comfortable Protective Mask N95 Mask Disposable Face Mask Adult Bedrail AR03, AR04, AR05, AR07 Stand-up Frame AH07, AH17 Sofa Stand Assist: AA34 Footwear Aid: AA26 Relyon Steady HandRail: AH20 Safety 1st(Medicine Dropper with Spill Guard) Disposable Isolation Garment Isolation Gown Protective Clothing disposable glove Medical Disposable Protective Clothing Medical Isolation Gown Surgical Isolation Gown Face shield Hand sanitizer Face shield GripEase Toilet Frame: AA44 Toilet Frame AA41, AA42 Disposable hat Safety 1st(Medicine Spoon) Safety 1st(bottle medicine dispenser) Safety 1st(Probe cover) Safety 1st(3-In-1 Digital Themometer) Goggle Shoe Helper AA21, AA25 Safety 1st( toothbrush,finger tooth brush)

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FXP	Cover, Shoe, Operating-Room	General, Plastic Surgery	Class 1	878.4040	2020-03-12
KHY	Cane, Safety Walk	Physical Medicine	Class 1	890.3075	2020-12-02
LKB	Pad, Alcohol, Device Disinfectant	Unknown	Class U	N/A	2020-08-03
QTC	Adult Portable Bed Rails For Medical Purposes	Physical Medicine	Class 1	890.5050	2025-12-03
MSH	Respirator, Surgical	General, Plastic Surgery	Class 2	878.4040	2020-03-12
FNJ	Bed, Manual	General Hospital	Class 1	880.5120	2020-12-02
IKX	Aid, Transfer	Physical Medicine	Class 1	890.5050	2020-12-02
KCM	Dropper, Ent	Ear, Nose, Throat	Class 1	874.5220	2019-12-30
OEA	Non-Surgical Gown	General, Plastic Surgery	Class 1	878.4040	2020-03-12
LYU	Accessory, Surgical Apparel	General, Plastic Surgery	Class 1	878.4040	2020-03-12
LRJ	Disinfectant, Medical Devices	General Hospital	Class 1	880.6890	2020-03-12
ILS	Adaptor, Hygiene	Physical Medicine	Class 1	890.5050	2025-12-03
FYF	Cap, Surgical	General, Plastic Surgery	Class 1	878.4040	2020-03-12
KYX	Dispenser, Liquid Medication	General Hospital	Class 1	880.6430	2019-12-30
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2023-12-11
HOY	Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)	Ophthalmic	Class 1	886.4750	2020-08-03
ILT	Adaptor, Recreational	Physical Medicine	Class 1	890.5050	2020-12-02
EFW	Toothbrush, Manual	Dental	Class 1	872.6855	2019-07-09

Official Correspondent

Angel Ge

US Agent Details

Yueting Zhu Business: SOUTH BAY INNOVATION LLC Email: southbayinnovation@southbayinnovation.com Phone: (424) 3769142

Related Public Records

Same Entity

Guangzhou Baoli Hardware & Electronic 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
K830425	Maddak, Inc.	TOILET SEAT RAISED	1983-05-09
K010462	Avita Corporation	AVITA PICCOLO/EXATO INFARED EAR THERMOMETER (TS2 & TS4 SERIES)	2001-04-11
K760421	Arbrook Mfg. Corp.	THERMOMETER, SURVALENT-ELECTRONIC	1976-08-23
K813409	Yellow Springs Instrument Co., Inc.	MODEL 2100 DUAL-DISPLAY TELE-THERMOMETER	1981-12-18

Similar Registrations

Registration Number	Establishment Name	Location
3014314985	ANHUI MEDPUREST MEDICAL TECHNOLOGY CO.,LTD	Anqing Anhui, CN
3013429557	HEYUAN HONG DE MEDICAL PRODUCTS CO., LTD.	Heyuan City Guangdong, CN
3038718579	OKETZ LOGISTICS LLC	Coral Gables, FL, US
3008808082	PLANET(SHANGHAI) INTERNATIONAL CO.,LTD	shanghai, CN
9680934	SUZHOU HENGXIANG IMP. & EXP. CO., LTD	SUZHOU Jiangsu, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3013823570. Last updated year: 2026. Please use registration number 3013823570 when referencing this establishment in official correspondence.