Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3021031769

FEI Number

3021031769

Entity Name

Shenzhen Sanping Image Technology Co., Ltd.

City/State/Country

Shenzhen Guangdong, CN

Establishment Address

Room 203, No. 634, Shajing Road, Buchong Community, Shajing Street, Bao'an District, Shenzhen Guangdong 518104, CN

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Manufacture Medical Device

Owner / Operator

Shenzhen Sanping Image Technology Co., Ltd (Owner Number: 10083057)

Owner / Operator Contact Address

Room 203,No.634,Shajing Road,Buchong Community,Shajing Street,Bao'an District, Shenzhen, CN-GD 518000, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K242010

PMA Number

N/A

All Registered Proprietary Names

Flexible video laryngoscope(SP-HJC) Flexible Ureterorenoscope system Bronchoscope System

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
CAL	Laryngoscope, Non-Rigid	Anesthesiology	Class 1	868.5530	2021-10-21
FGB	Ureteroscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2025-12-04
EOQ	Bronchoscope (Flexible Or Rigid)	Ear, Nose, Throat	Class 2	874.4680	2025-03-24

Official Correspondent

Vincent Pan

US Agent Details

Yang Bolin Business: Prosidio Inc Email: bolin99@163.com Phone: (914) 5102314

Related Public Records

Same Entity

Shenzhen Sanping Image 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
K915458	Psi Medical Products, Inc.	URETEROSCOPE	1992-01-30
K811059	Pentax Precision Instrument Corp.	PENTAX BRONCHOFIBERSCOPE #FB-15A	1981-05-27
K142934	Covidien	CrossCountry Transbronchial Access Tool straight, CrossCountry Transbronchial Access Tool curved	2015-06-17
K240075	FUJIFILM Healthcare Americas Corporation	FUJIFILM Endoscope Model EB-710XT	2024-02-07

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0025-2020	AURIS HEALTH INC	2	Monarch, Aspirating Biopsy Needle, REF: MBR-000012, Rx Only, UDI: B634MBR0000120

Similar Registrations

Registration Number	Establishment Name	Location
3010202439	Karl Storz Endoscopy-America, Inc.	El Segundo, CA, US
3009420598	Primo Medical Group, Inc	W Bridgewater, MA, US
3003882387	B. ALI IMPEX	SIALKOT, Punjab, PK
3030656972	SHENZHEN JUNYUAN MEDICAL EQUIPMENT CO., LTD	Shenzhen Guangdong, CN
3014233600	SHENZHEN CORERAY TECHNOLOGY CO., LTD.	Shenzhen Guangdong, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3021031769. Last updated year: 2026. Please use registration number 3021031769 when referencing this establishment in official correspondence.