Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3021284283

FEI Number

3021284283

Entity Name

BESMED HEALTH BUSINESS CORP.-Chiayi

City/State/Country

Dalin Township Chiayi, TW

Establishment Address

No. 42, Dapumeiyuanqu 3rd Rd.,, Dalin Township Chiayi 622011, TW

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

BESMED HEALTH BUSINESS CORP. (Owner Number: 9047866)

Owner / Operator Contact Address

No. 5, Lane 116, Wu-Kong 2nd Rd., Wu-ku District, New Taipei City, TW-TPE 24888, TW

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Besmed silicone drainage system Besmed Tracheal Tube Stylet Besmed Test Lung GUEDEL AIRWAY BESMED BERMAN LARYNGEAL AIRWAY MASK Besmed Volumetric Incentive Spirometer Besmed TriBall Incentive Spirometer Besmed Vessel Loop Besmed Bacterial Filter and HMEF BeVAC Portable Suction Unit

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GBQ	Catheter, Continuous Irrigation	General, Plastic Surgery	Class 1	878.4200	2022-05-30
BSR	Stylet, Tracheal Tube	Anesthesiology	Class 1	868.5790	2025-04-16
BXW	Calibrator, Volume, Gas	Anesthesiology	Class 1	868.1870	2024-09-30
CAE	Airway, Oropharyngeal, Anesthesiology	Anesthesiology	Class 1	868.5110	2007-06-26
BWF	Spirometer, Therapeutic (Incentive)	Anesthesiology	Class 2	868.5690	2015-01-20
BWF	Spirometer, Therapeutic (Incentive)	Anesthesiology	Class 2	868.5690	2014-05-12
KDC	Instrument, Surgical, Disposable	General, Plastic Surgery	Class 1	878.4800	2022-08-10
CAH	Filter, Bacterial, Breathing-Circuit	Anesthesiology	Class 2	868.5260	2024-12-03
GCX	Apparatus, Suction, Operating-Room, Wall Vacuum Powered	General Hospital	Class 2	880.6740	2023-08-15

Official Correspondent

SARAH LU

US Agent Details

Eric Zou Email: ericyzou@gmail.com Phone: (909) 5913288

Related Public Records

Same Entity

BESMED HEALTH BUSINESS CORP.

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3006547005	NINGBO BESMED MEDICAL EQUIPMENT CORP.	NINGBO Zhejiang, CN
9710567	Besmed Health Business Corporation	New Taipei City, TW

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K831798	I M, Inc.	DISPOSABLE SCALPELS	1983-07-19
K962045	Mallinckrodt Medical	ANESTHESIA BREATHING CIRCUIT/ANESTHESIA BREATHING KIT	1996-11-26

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.

Similar Registrations

Registration Number	Establishment Name	Location
3043349275	KAIROMED LLC	Beltsville, MD, US
3005841027	Welmed, Inc.	Chicago, IL, US
1625425	ARGON MEDICAL DEVICES INC.	ATHENS, TX, US
3010339057	SUZHOU TEXNET	Suzhou Jiangsu, CN
1043214	DEROYAL INDUSTRIES, INC.	POWELL, TN, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3021284283. Last updated year: 2026. Please use registration number 3021284283 when referencing this establishment in official correspondence.