Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3009241523

FEI Number

3009241523

Entity Name

SHANGHAI BERRY ELECTRONIC TECH CO., LTD.

City/State/Country

Shanghai, CN

Establishment Address

Unit 104 1st Floor 7th Building No. 1188, Lianhang Road Minhang District, Shanghai 201112, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Shanghai Berry Electronic Tech Co., Ltd. (Owner Number: 10049547)

Owner / Operator Contact Address

Unit 104 1st Floor 7th Building No. 1188, Lianhang Road Minhang District, Shanghai, CN-SH 201112, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K172141

PMA Number

N/A

All Registered Proprietary Names

BM2000A BM20 BM1000 Berry Wellness Pulse Oximeter BM2000A Pulse Oximeter BM1000A BM20 Pulse Oximeter Oximeter Pulse Oximeter BM1000; Pulse Oximeter BM1000C bm1000 rx only

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
PGJ	Oximeter, Wellness	Cardiovascular	Class 2	870.2700	2024-03-04
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2015-06-17
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2025-12-15
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2018-04-13

Official Correspondent

Xuezhi Yin

US Agent Details

hui hong Business: ABMED MEDICAL TECHNOLOGY INC Email: info@abmed.us Phone: (303) 8000162

Related Public Records

Same Entity

Shanghai Berry Electronic Tech 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
3013116677	PROSOMNUS SLEEP TECHNOLOGIES	Pleasanton, CA, US
3007858728	Shenzhen Hexin ZONDAN Medical Equipment Co., Ltd	Shenzhen Guangdong, CN
3012725363	EASY HEALTHCARE CORPORATION	Darien, IL, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009241523. Last updated year: 2026. Please use registration number 3009241523 when referencing this establishment in official correspondence.