Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3017609572

FEI Number

3017609572

Entity Name

ZHONGSHAN HONGZE MEDICAL TECHNOLOGY CO., LTD.

City/State/Country

Zhongshan Guangdong, CN

Establishment Address

4/F,Building 1,NO.9,Fuze Road,Sanjiao Town, Zhongshan Guangdong 528445, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Zhongshan Hongze Medical Technology Co., Ltd. (Owner Number: 10077973)

Owner / Operator Contact Address

4/F,Building 1,NO.9,Fuze Road,Sanjiao Town, Zhongshan, CN-GD 528445, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Oropharyngeal Airway Breathing bags Nasopharyngeal Airway Non-rebreathing Mask 0184 CO2 Sampling line; 0184T CO2 Sampling line; 0139 CO2 Sampling line; 0182 CO2 Sampling line Oxygen Mask Aerosol Mask with Nebulizer

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
CAE	Airway, Oropharyngeal, Anesthesiology	Anesthesiology	Class 1	868.5110	2022-04-13
BTC	Bag, Reservoir	Anesthesiology	Class 1	868.5320	2023-08-16
BTQ	Airway, Nasopharyngeal	Anesthesiology	Class 1	868.5100	2022-04-13
KGB	Mask, Oxygen, Non-Rebreathing	Anesthesiology	Class 1	868.5570	2022-04-13
CCK	Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase	Anesthesiology	Class 2	868.1400	2025-06-17
BYG	Mask, Oxygen	Anesthesiology	Class 1	868.5580	2020-10-07

Official Correspondent

Amy XU

US Agent Details

Amy XU Business: BARBARAS DEVELOPMENT, INC. Email: amyxu@bd.inc Phone: (888) 9025500

Related Public Records

Same Entity

Zhongshan Hongze 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
K142467	Abeon Medical Corporation	IntelAir Nasal Airway Support System	2014-11-24
K861213	Datex Division Instrumentarium Corp.	PB 254 IR - SPECTROMETER	1986-04-04
K172904	Philips Medizin Systeme Boeblingen GmbH	IntelliVue Capnography Extension, IntelliVue Microstream Extension	2017-12-26

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0002-2014	King Systems Corp.	1	King LTS-D Oropharyngeal Airways Product Usage: The King LTS-D is intended for use in adult patients (in excess of 25 kg) for controlled ventilation during anesthesia for procedures that are short in duration and when the patient is considered to have a low risk of aspiration of stomach contents.
Z-0021-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	CAPNOSTREAM 20P (US) N, Part Number CS08651-01
Z-0024-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	CAPNOSTREAM 20 (US) N W/PRINTER, Part Number CS08657
Z-0025-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	CAPNOSTREAM 20P (US) N W/PRINTER - ROHS, Part Number CS08657-02
Z-0026-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	CAPNOSTREAM 20P (US) N W/PRINTER, Part Number CS08657-01

Similar Registrations

Registration Number	Establishment Name	Location
3037007211	ARETE MEDICAL DEVICES	Mullica Hill, NJ, US
3012508471	P3 MEDICAL LTD	Bristol Bristol, City of, GB
3014829416	MCMURRAY MEDICAL	Minneapolis, MN, US
3015314035	Bio-Med Healthcare Products Pvt. Ltd.	Palwal Haryana, IN
3008281139	DANYANG XINYA VALVE CO., LTD.	Danyang Jiangsu, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3017609572. Last updated year: 2026. Please use registration number 3017609572 when referencing this establishment in official correspondence.