Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3021246306

FEI Number

3021246306

Entity Name

GUANGZHOU RED PINE MEDICAL INSTRUMENT CO.,LTD.

City/State/Country

Guangzhou Guangdong, CN

Establishment Address

Room 501, 502, 503 and 701-02 Building 22, No.388 Lianyun Road, Huangpu District, 510000 Guangzhou City, Guang, Guangzhou Guangdong 510000, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Guangzhou Red Pine Medical Instrument Co., Ltd. (Owner Number: 10083216)

Owner / Operator Contact Address

12 F, No.87 Luoxuan Avenue, Guangzhou International Bioisland, Huangpu District, Guangzhou, CN-GD 510000, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K243321

PMA Number

N/A

All Registered Proprietary Names

Endoscopic Video Image Processor Single-Use Video Gastroscope Single-Use Video Colonoscope Endoscopic Video Image Processor Ascend Single-Use Flexible Ureteroscope Single-Use Video Flexible Ureterorenoscope Endoscopic Video Image Processor Single-Use Video Flexible Cystoscope Single-Use Video Hysteroscope Endoscopic Video Image Processor Single-Use Video Flexible Cysto-Nephroscope Ascend Single-Use Flexible Cysto-Nephroscope HD Single-Use Video Flexible Cysto-Nephroscope Endoscopic Video Image Processor Endoscopic Video Image Processor

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FDS	Gastroscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2024-08-18
FDF	Colonoscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2024-08-18
FET	Endoscopic Video Imaging System/Component, Gastroenterology-Urology	Gastroenterology, Urology	Class 2	876.1500	2024-08-18
FGB	Ureteroscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2023-04-18
FAJ	Cystoscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2024-08-18
HIH	Hysteroscope (And Accessories)	Obstetrics/Gynecology	Class 2	884.1690	2024-08-04
FAJ	Cystoscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2025-12-22
FAJ	Cystoscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2024-07-16
FET	Endoscopic Video Imaging System/Component, Gastroenterology-Urology	Gastroenterology, Urology	Class 2	876.1500	2025-04-28

Official Correspondent

Weihua Yang

US Agent Details

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

Related Public Records

Same Entity

Guangzhou Red Pine Medical Instrument 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
K232314	FUJIFILM Healthcare Americas Corporation	Hood (DH-106STL, DH-116STL, DH-126STL, DH-096ST)	2023-09-01
K915458	Psi Medical Products, Inc.	URETEROSCOPE	1992-01-30
K935716	KARL STORZ Endoscopy-America, Inc.	KARL STORZ FIXED MAGNIFICATION TELESCOPE/KS VARIABLE MAGNIFICATION TELESCOPE	1995-11-16

Similar Registrations

Registration Number	Establishment Name	Location
3006161756	FUJIFILM Healthcare Manufacturing Corporation Sano Office	Sano City Tochigi, JP
3004837686	Micro-Tech (Nanjing) Co., Ltd.	NAN JING Jiangsu, CN
2020550	KARL STORZ ENDOSCOPY-AMERICA, INC.	Auburn, MA, US
3015136743	STERI-TECH CO.,LTD.	KAZO-SHI Saitama, JP
3008797804	ALTON SHANGHAI MEDICAL INSTRUMENTS CO LTD	Shanghai, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3021246306. Last updated year: 2026. Please use registration number 3021246306 when referencing this establishment in official correspondence.