Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3006547005

FEI Number

3006547005

Entity Name

NINGBO BESMED MEDICAL EQUIPMENT CORP.

City/State/Country

NINGBO Zhejiang, CN

Establishment Address

NO.51, MO GAN SHAN RD, BEILUN, NINGBO Zhejiang 315800, CN

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 MOUTHPIECE BESMED BITE BLOCK MOUTHPIECE Besmed Jet Nebulizer Bottle Set Besmed Valved Tee Adapter NCPAP Circuit Neonatal Circuit Besmed Reusable Jet Nebulizer BESMED CRR POCKET MASK BESMED HI-OXYGEN MASK Besmed CO2 Monitoring Line With and Without In-Line Filter Besmed CO2 Monitoring Line W/Nasal Cannula GUEDEL AIRWAY BESMED BERMAN LARYNGEAL AIRWAY MASK BESMED HUMIDIFIER Soft Tracheostomy Mask AEROSOL , OXYGEN BESMED FACE TENT SILICONE MASK BESMED OXYGEN MASK PVC BESMED OXYGEN TUBING Bonnet Nasal mask BESMED HEAD STRAP

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
BYP	Mouthpiece, Breathing	Anesthesiology	Class 1	868.5620	2007-06-26
CAF	Nebulizer (Direct Patient Interface)	Anesthesiology	Class 2	868.5630	2010-08-29
BZO	Set, Tubing And Support, Ventilator (W Harness)	Anesthesiology	Class 1	868.5975	2014-07-02
CAF	Nebulizer (Direct Patient Interface)	Anesthesiology	Class 2	868.5630	2015-07-07
KGB	Mask, Oxygen, Non-Rebreathing	Anesthesiology	Class 1	868.5570	2007-06-26
CCK	Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase	Anesthesiology	Class 2	868.1400	2015-02-11
CAE	Airway, Oropharyngeal, Anesthesiology	Anesthesiology	Class 1	868.5110	2007-06-26
KFZ	Humidifier, Non-Direct Patient Interface (Home-Use)	Anesthesiology	Class 1	868.5460	2007-06-26
BYG	Mask, Oxygen	Anesthesiology	Class 1	868.5580	2007-06-26
BYX	Tubing, Pressure And Accessories	Anesthesiology	Class 1	868.5860	2007-06-27
BTK	Strap, Head, Gas Mask	Anesthesiology	Class 1	868.5560	2007-06-26

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
9710567	Besmed Health Business Corporation	New Taipei City, TW
3021284283	BESMED HEALTH BUSINESS CORP.-Chiayi	Dalin Township Chiayi, TW

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K163485	Adherium (Nz), Ltd.	SmartTouch	2017-08-30
K781467	Travenol Laboratories, S.A.	U-FLOAT VALVE 2D9023	1978-09-07
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-0031-2026	Percussionaire Corporation	1	Phasitron 5, IPV In-Line Valve, (Intrapulmonary Percussive Ventilation) REF: P5-TEE-20 (pack of 20)/ P5-TEE (individual) with In-Line Valve Sentec Instructions for Use
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

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3016678045	Schneider ASR B.V.	Rotterdam-Albrandswaard Zuid-Holland, NL
1225492	NextPhase Medical Devices LLC	ROCHESTER, NH, US
3033959233	Jaeger Medical America Inc.	Moreno Valley, CA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3006547005. Last updated year: 2026. Please use registration number 3006547005 when referencing this establishment in official correspondence.