Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3008570547

FEI Number

3008570547

Entity Name

BEIJING RONGRUI CENTURY SCIENCE TECHNOLOGY CO.,LTD

City/State/Country

Beijing, CN

Establishment Address

3rd Floor, West zone,No.1 Building,No.7 Yard, Fengxian Middle Road,Haidian District, Beijing 100094, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Beijing Rongrui Century Science Technology Co.,Ltd (Owner Number: 10033666)

Owner / Operator Contact Address

3 Floor, West Zone, No. 1 Building, No.7, Fengxian Middle Rd. Haidian District, Beijing, CN-BJ 100094, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K222370

PMA Number

N/A

All Registered Proprietary Names

CABLE, ELECTRODE PULSE OXIMETER SENSOR CST017CA PULSE OXIMETER SENSOR CSP027DN-M200 PULSE OXIMETER SENSOR CST017DI PULSE OXIMETER SENSOR CSJ017DA PULSE OXIMETER SENSOR CSP027DN-M100 PULSE OXIMETER SENSOR CSP027DA-P100 PULSE OXIMETER SENSOR CSP001DN-M200 PULSE OXIMETER SENSOR CSJ001DI PULSE OXIMETER SENSOR CSP001DI-M300 PULSE OXIMETER SENSOR CSJ001CI PULSE OXIMETER SENSOR CST001DA PULSE OXIMETER SENSOR CST017DA PULSE OXIMETER SENSOR CSP001DP-P300 PULSE OXIMETER SENSOR CSJ017CA PULSE OXIMETER SENSOR CSP001DP-P200 PULSE OXIMETER SENSOR CSP001DA-P300 PULSE OXIMETER SENSOR CSJ002CI PULSE OXIMETER SENSOR RSA002DN PULSE OXIMETER SENSOR CSJ002DI PULSE OXIMETER SENSOR CSP027DA-P200 PULSE OXIMETER SENSOR CSY017DN PULSE OXIMETER SENSOR CSP001DI-M100 PULSE OXIMETER SENSOR CSP001DN-E100 PULSE OXIMETER SENSOR MDSP2ADT-N PULSE OXIMETER SENSOR CSP027DP-P100 PULSE OXIMETER SENSOR CSP001DI-M200 PULSE OXIMETER SENSOR CSJ002DA PULSE OXIMETER SENSOR CSP001DP-P100 PULSE OXIMETER SENSOR CSP027DI-M200 PULSE OXIMETER SENSOR RSA002DN-M100 PULSE OXIMETER SENSOR CST017EA PULSE OXIMETER SENSOR CSJ002CA PULSE OXIMETER SENSOR MDSP2NAD3-N PULSE OXIMETER SENSOR CST002CA PULSE OXIMETER SENSOR CSP001DN-E300 PULSE OXIMETER SENSOR CSP027DP-P200 PULSE OXIMETER SENSOR CST001CI PULSE OXIMETER SENSOR CSJ017DA-M200 PULSE OXIMETER SENSOR CST017DA-M200 PULSE OXIMETER SENSOR CSP027DI-M100 PULSE OXIMETER SENSOR CST001CA PULSE OXIMETER SENSOR(DISPOSABLE AND REPEATABLE) MODEL CST002DI PULSE OXIMETER SENSOR CSJ017DI PULSE OXIMETER SENSOR MDSP2NAD-N OXIMETER PULSE OXIMETER SENSOR CSJ001CA PULSE OXIMETER SENSOR CSP001DA-P100 PULSE OXIMETER SENSOR CST004CA PULSE OXIMETER SENSOR MDSP2INF-N PULSE OXIMETER SENSOR CSJ001DA PULSE OXIMETER SENSOR CSP001DN-M100 PULSE OXIMETER SENSOR CST002DA PULSE OXIMETER SENSOR OSA051DN-M100 PULSE OXIMETER SENSOR CSP001DN-M300 PULSE OXIMETER SENSOR(DISPOSABLE AND REPEATABLE) MODEL CST002CI PULSE OXIMETER SENSOR CSP001DA-P200 PULSE OXIMETER SENSOR CSJ004CA PULSE OXIMETER SENSOR CST001DI PULSE OXIMETER SENSOR MDSP2PED-N PULSE OXIMETER SENSOR CSP001DN-E200 PULSE OXIMETER SENSOR CST017CI PULSE OXIMETER SENSOR CSJ017CI Disposable Temporary Pacing Cable RCT090 SpO2 Extension Cable SpO2 Extension Cable OCT018-S SpO2 Extension Cable OCT009 SpO2 Extension Cable OCT006 SpO2 Extension Cable OCT009-L SpO2 Extension Cable OCT017-OL SpO2 Extension Cable OCT111-L SpO2 Extension Cable OCT021-L SpO2 Extension Cable OCT111 SpO2 Extension Cable OCT018-O SpO2 Extension Cable OCT018-OSS SpO2 Extension Cable OCT017 SpO2 Extension Cable OCT017-L SpO2 Extension Cable OCT110 SpO2 Extension Cable OCT018-OL SpO2 Extension Cable OCT018-SS SpO2 Extension Cable OCT110-L SpO2 Extension Cable OCT111-OL SpO2 Extension Cable OCT111-O SpO2 Extension Cable OCT018-L SpO2 Extension Cable OCT018 SpO2 Extension Cable OCT018-OS SpO2 Extension Cable OCT017-O SpO2 Extension Cable OCT006-L

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
IKD	Cable, Electrode	Physical Medicine	Class 2	890.1175	2010-09-13
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2011-07-25
DSA	Cable, Transducer And Electrode, Patient, (Including Connector)	Cardiovascular	Class 2	870.2900	2016-10-26
DSA	Cable, Transducer And Electrode, Patient, (Including Connector)	Cardiovascular	Class 2	870.2900	2011-11-11
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2025-05-20
DSA	Cable, Transducer And Electrode, Patient, (Including Connector)	Cardiovascular	Class 2	870.2900	2025-05-20
DSA	Cable, Transducer And Electrode, Patient, (Including Connector)	Cardiovascular	Class 2	870.2900	2023-04-18

Official Correspondent

Ting Chen

US Agent Details

Wen Xu Email: infor@believe-med.com Phone: (443) 8968583

Related Public Records

Same Entity

Beijing Rongrui Century Science 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
K903523	Hewlett-Packard Co.	HP MODEL M1020A, ARTERIAL OXYGEN SAT/PLETH MODULE	1990-10-23
K973147	Nellcor Puritan Bennett, Inc.	NPB-295 PULSE OXIMETER	1997-11-14
K231243	Guangdong Genial Technology Co., Ltd.	Finger Clip Pulse Oximeter	2023-10-31
K971628	Somanetics Corp.	SOMANETICS INVOS 3100A CEREBRAL OXIMETER (INVOS)	1997-10-10
K153184	Shenzhen Caremed Medical Technology Co., Ltd.	Caremed Reusable & Disposable SPO2 Sensors	2017-01-04

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0020-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	CAPNOSTREAM 20 (US) N, Part Number CS08651
Z-0022-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	CAPNOSTREAM 20P (US) N - ROHS, Part Number CS08651-02
Z-0023-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	CAPNOSTREAM 20P (US) N - ROHS, Part Number CS08651-03
Z-0028-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	Capnostream20 (US) M, Part Number CS08653
Z-0029-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	Capnostream20 (US) M W/PRINTER, Part Number CS08659

Similar Registrations

Registration Number	Establishment Name	Location
3017528618	ATRILITY MEDICAL, INC.	Madison, WI, US
3003584029	Braemar Manufacturing, LLC	San Diego, CA, US
3030387292	WISE S.p.A.	Cologno Monzese Lombardy, IT
3033919280	DONGGUAN GOOCHAIN TECHNOLOGY CO., LTD	Dongguan Guangdong, CN
3017619000	SHENZHEN REDY-MED TECHNOLOGY CO., LTD.	Shenzhen Guangdong, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3008570547. Last updated year: 2026. Please use registration number 3008570547 when referencing this establishment in official correspondence.