Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3021962893

FEI Number

3021962893

Entity Name

SHENZHEN NARIG BIO-MEDICAL TECHNOLOGY CO., LTD.

City/State/Country

Shenzhen Guangdong, CN

Establishment Address

Room 516,Podium Building 12,shenzhen Bay Science and Technology Ecological Park,High-tech community, No.18,Technology South road,Yuehai streest,Nanshan District,Shenzhen City,, Shenzhen Guangdong 518052, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Shenzhen Narig Bio-Medical Technology Co., Ltd. (Owner Number: 10084192)

Owner / Operator Contact Address

1106 Room, East Tower, Digital Culture Industry Base, No.10128 Shennan Road, Nanshan District, Shenzhen, CN-GD 518052, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K211632

PMA Number

N/A

All Registered Proprietary Names

FRO-203 FRO-204 FRO-104 FRO-103 FRO-201 FRO-101 S-PR01 CF-100 CF-100B OxyKnight Finger CF-100B OxyKnight Finger CF-100A CF-100A NHO-100 FRO-202 FRO-100 OxyKnight Finger CF-100 S-PR02 FRO-200 FRO-102 FRO-104 OxyKnight Finger CF-100 FRO-204 FRO-200 CF-100B FRO-201 OxyKnight Finger CF-100A FRO-101 FRO-203 OxyKnight Finger CF-100B S-PR01 FRO-202 FRO-103 CF-100A FRO-102 FRO-100 S-PR02 CF-100 M230A

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
PGJ	Oximeter, Wellness	Cardiovascular	Class 2	870.2700	2023-03-06
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2022-01-24

Official Correspondent

Fei Han

US Agent Details

Anna SUN Business: SUN LUNA STAR LLC Email: usa@medpath.pro Phone: (626) 2005096

Related Public Records

Same Entity

Shenzhen Narig Bio-Medical 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
3042989733	MARKEN HEALTHTECH LIMITED	NASHIK Maharashtra, IN
3015142815	Tianjin Choice Medical Device Co., Ltd.	Tianjin, CN
3009241523	SHANGHAI BERRY ELECTRONIC TECH CO., LTD.	Shanghai, CN
3013116677	PROSOMNUS SLEEP TECHNOLOGIES	Pleasanton, CA, US
3007858728	Shenzhen Hexin ZONDAN Medical Equipment Co., Ltd	Shenzhen Guangdong, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3021962893. Last updated year: 2026. Please use registration number 3021962893 when referencing this establishment in official correspondence.