Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3013055504

FEI Number

3013055504

Entity Name

BONREE MEDICAL CO., LTD

City/State/Country

Zhongshan Guangdong, CN

Establishment Address

1st floor of Building No.2, Building No.4, Longzhu Village Economic Estate, Longzhu Avenue, Nanlang, Zhongshan Guangdong 528451, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Bonree Medical Co., Ltd. (Owner Number: 10052072)

Owner / Operator Contact Address

1st floor of Building No.2, Building No.4, Longzhu Village Economic Estate, Longzhu Avenue, Nanlang, Zhongshan, CN-GD 528451, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Pressure Tubing Oxygen Tubing Non-Rebreathing Oxygen Mask Oropharyngeal Airway Laryngeal Mask Device Aspiration Tubing Suction Tubing Nasopharyngeal Airway Oxygen Mask Pressure Tubing Suction Catheter Yankauer Suction Tip W/Tubing Yankauer Suction Set Yankauer Suction Tube Yankauer Suction Hande Apparatus Suction Suction Catheter

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
BYX	Tubing, Pressure And Accessories	Anesthesiology	Class 1	868.5860	2016-06-09
KGB	Mask, Oxygen, Non-Rebreathing	Anesthesiology	Class 1	868.5570	2016-06-09
CAE	Airway, Oropharyngeal, Anesthesiology	Anesthesiology	Class 1	868.5110	2016-06-14
BYY	Tube, Aspirating, Flexible, Connecting	General Hospital	Class 2	880.6740	2025-03-14
BTQ	Airway, Nasopharyngeal	Anesthesiology	Class 1	868.5100	2016-06-09
BYG	Mask, Oxygen	Anesthesiology	Class 1	868.5580	2016-06-09
JOL	Catheter And Tip, Suction	General Hospital	Class 2	880.6740	2016-08-16
GCX	Apparatus, Suction, Operating-Room, Wall Vacuum Powered	General Hospital	Class 2	880.6740	2016-06-09

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

Bonree Medical Co., Ltd.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

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-0007-2013	Invuity, Inc.	2	BriteField illuminated Suction Device; Model numbers 8Fr, 10Fr and 12Fr, Kit (included 8Fr, 10Fr and 12Fr and a sterilization tray. The Invuity Brite Field Illuminated Suction Device is intended to aspirate from the surgical site and to provide illumination from a high intensity light source.

Similar Registrations

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3009747810	NINGBO HUAKUN MEDICAL EQUIPMENT CO.,LTD	Cixi Zhejiang, CN
1043572	STERIS CORPORATION	MONTGOMERY, AL, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3013055504. Last updated year: 2026. Please use registration number 3013055504 when referencing this establishment in official correspondence.