Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3014652024

FEI Number

3014652024

Entity Name

CEA GROUP INTERNATIONAL CO.,LTD

City/State/Country

Wenzhou Zhejiang, CN

Establishment Address

Sanjiali Industrial Zone,Zhucheng Road,Panshi, Wenzhou Zhejiang 325602, CN

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device

Owner / Operator

CEA Group International Co.,Ltd (Owner Number: 10095238)

Owner / Operator Contact Address

Sanjiali Industrial Zone,Zhucheng Road,Panshi, Wenzhou, CN-ZJ 325602, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K240092

PMA Number

N/A

All Registered Proprietary Names

YIMI LIFE, GLOBAL INDUSTRIAL

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2026-02-10

Official Correspondent

No official correspondent registered.

US Agent Details

David Lennarz Business: Registrar Corp Email: David.Lennarz@registrarcorp.com Phone: (757) 2240177

Related Public Records

Same Entity

CEA Group International 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
1062836	DIGICARE BIOMEDICAL TECHNOLOGY, INC.	BOYNTON BEACH, FL, US
3013250653	MASIMO CORPORATION	Irvine, CA, US
3013418500	Quintana Supply, a division of Thomas Scientific	Haverhill, MA, US
9614470	RADIOMETER BASEL AG	BASEL Basel-Stadt, CH
3026960443	Cicor Medtec Bucharest	Bucharest Bucuresti, RO

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3014652024. Last updated year: 2026. Please use registration number 3014652024 when referencing this establishment in official correspondence.