Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9710567

FEI Number

3003256355

Entity Name

Besmed Health Business Corporation

City/State/Country

New Taipei City, TW

Establishment Address

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

Establishment Type(s)

Manufacture Medical Device,Export Device to the United States But Perform No Other Operation on 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 Flow Sensor Besmed Nasal Washer BESMED VARIOUS MODELS OF TENS, BE-550/BE-660 Besmed Introduction/Drainage Catheter & Accessories BESMED NOSE CLIP Besmed TriBall Incentive Spirometer Besmed Peep Valve BESMED SINGLE USE BESMED CLOSED WOUND BESMED CLOSED WOUND RESERVOIR BULB Besmed Reusable Jet Nebulizer ANESTHESIA BREATHING CIRCUIT T-piece T-piece, Mask (Size 00, 000), Manometer, Infant Manifold Exhalation Valve (CT-11470) Manifold Exhalation Valve (CT-11420) T-piece, Mask (Size 00, 000), Infant Manifold Exhalation Valve (CT-11450) BESMED ANESTHESIA CIRCUIT Besmed Peak Flow Meter Besmed Menstrual Cup COLD PACK BESMED HOT Compressor Nebulizer Besmed manometer BESMED AIR CUSHION MASK BESMED SILICONE AIR CUSHION MASK BESMED OXYGEN TUBING Besmed Powered Percussor BESMED VARIOUS MOD BESMED SINGLE USE Besmed Introduction Catheter and Accessories BESMED HUMIDIFIER Besmed Test Lung NCPAP Generator bubble cpap kit Besmed Disposable Pressure Manometer BESMED ICE & HOT BAG BE-096 Moist Heating Pad, Shoulder Type, No Band Switch Moist Heating Pad, 14'' X 17'', LED Switch VAP-MOIST Moist Heating Pad, LED Switch, 220V, 22.4 X 6.7 VAP-MOIST Moist Heating Pad, LED Switch, 220V, 21.7 X 4 VAP-MOIST Moist Heating Pad, LED Switch, 220V, 29 X 13 Moist Heating Pad, 14'' X 27'', Smart Digital Switch Moist Heating Pad, 4'' X 17'', Smart Digital Switch VAP-MOIST Moist Heating Pad, Digital Switch, 220V, 16.5 X 13 Moist Heating Pad, 4'' X 17'', No Band Switch Moist Heating Pad, 14'' X 17'', Smart Digital Switch VAP-MOIST Moist Heating Pad, Digital Switch, 220V, 23.2 X 13 VAP-MOIST Moist Heating Pad, LED Switch, 220V, 16.5 X 13 VAP-MOIST Moist Heating Pad, Digital Switch, 220V, 22.4 X 6.7 Moist Heating Pad, Shoulder Type, Smart Digital Switch Moist Heating Pad, 14'' X 27'', Digital Switch Moist Heating Pad, 14'' X 27'', No Band Switch Moist Heating Pad, Shoulder Type, Digital Switch VAP-MOIST Moist Heating Pad, Digital Switch, 220V, 21.7 X 4 Moist Heating Pad, 14'' X 20'', No Band Switch Moist Heating Pad, Shoulder Type, LED Switch Moist Heating Pad, 4'' X 17'', Digital Switch Moist Heating Pad, 14'' X 20'', Smart Digital Switch VAP-MOIST Moist Heating Pad, Digital Switch, 220V, 19.5 X 18.5 Heating pad Heating Pad, Standard 30 X 39 cm Moist Heating Pad, 14'' X 20'', Digital Switch Moist Heating Pad, 14'' X 17'', No Band Switch Heating pad Heating Pad, Kingsize 30 X 60 cm Moist Heating Pad, 14'' X 17'', Digital Switch Moist Heating Pad, 4'' X 17'', LED Switch VAP-MOIST Moist Heating Pad, LED Switch, 220V, 23.2 X 13 Moist Heating Pad, 14'' X 20'', LED Switch VAP-MOIST Moist Heating Pad, LED Switch, 220V, 19.5 X 18.5 VAP-MOIST Moist Heating Pad, Digital Switch, 220V, 29 X 13 Moist Heating Pad, 14'' X 27'', LED Switch BESMED HEATING PAD BE-240 BESMED WATER TRAP BE-560 BESMED MINI MASSAGER Soft Tracheostomy Mask AEROSOL , OXYGEN BESMED FACE TENT SILICONE MASK BESMED OXYGEN MASK PVC Besmed Various Models of Powered Muscle Stimulator, BE-560/BE-580 Besmed CO2 Monitoring Line With and Without In-Line Filter Besmed CO2 Monitoring Line W/Nasal Cannula BESMED COLD HOT WRAP BE-140 Besmed Bacterial Filter and HMEF Besmed Anesthesia Breathing Bags; Besmed Anesthesia Circuit; Besmed Anesthesia Circuit Assessories; Besmed Test Lung BESMED REBREATHING BAG Hi-iNFLOW NCPAP Nasal Cannula Nasal prong interface of Nasal CPAP iNFLOW NCAT Nasal Cannula NP-FLOW BESMED NASAL OXYGEN CANNULA

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
BXP	Transducer, Gas Flow	Anesthesiology	Class 1	868.2885	2020-04-29
KMA	Irrigator, Powered Nasal	Ear, Nose, Throat	Class 1	874.5550	2015-08-24
GZJ	Stimulator, Nerve, Transcutaneous, For Pain Relief	Neurology	Class 2	882.5890	2011-09-13
GBS	Catheter, Ventricular, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4200	2015-01-20
BXJ	Clip, Nose	Anesthesiology	Class 1	868.6225	2007-06-26
BWF	Spirometer, Therapeutic (Incentive)	Anesthesiology	Class 2	868.5690	2014-05-12
BYE	Attachment, Breathing, Positive End Expiratory Pressure	Anesthesiology	Class 2	868.5965	2016-06-06
BTM	Ventilator, Emergency, Manual (Resuscitator)	Anesthesiology	Class 2	868.5915	2001-09-26
GCY	Apparatus, Suction, Single Patient Use, Portable, Nonpowered	General, Plastic Surgery	Class 1	878.4680	2007-06-26
CAF	Nebulizer (Direct Patient Interface)	Anesthesiology	Class 2	868.5630	2015-07-07
CAI	Circuit, Breathing (W Connector, Adaptor, Y Piece)	Anesthesiology	Class 1	868.5240	2007-06-26
CAN	Regulator, Pressure, Gas Cylinder	Anesthesiology	Class 1	868.2700	2021-01-28
BZH	Meter, Peak Flow, Spirometry	Anesthesiology	Class 2	868.1860	2018-01-12
HHE	Cup, Menstrual	Obstetrics/Gynecology	Class 2	884.5400	2021-03-02
IMD	Pack, Hot Or Cold, Disposable	Physical Medicine	Class 1	890.5710	2007-06-26
BTI	Compressor, Air, Portable	Anesthesiology	Class 2	868.6250	2017-12-20
BXH	Gauge, Gas Pressure, Cylinder/Pipeline	Anesthesiology	Class 1	868.2610	2021-07-13
BSJ	Mask, Gas, Anesthetic	Anesthesiology	Class 1	868.5550	2007-06-26
BYX	Tubing, Pressure And Accessories	Anesthesiology	Class 1	868.5860	2007-06-27
ISA	Massager, Therapeutic, Electric	Physical Medicine	Class 1	890.5660	2019-01-16
BTM	Ventilator, Emergency, Manual (Resuscitator)	Anesthesiology	Class 2	868.5915	2006-05-17
GBX	Catheter, Irrigation	General, Plastic Surgery	Class 1	878.4200	2015-08-24
KFZ	Humidifier, Non-Direct Patient Interface (Home-Use)	Anesthesiology	Class 1	868.5460	2007-06-26
BXW	Calibrator, Volume, Gas	Anesthesiology	Class 1	868.1870	2024-09-30
CCQ	Nebulizer, Medicinal, Non-Ventilatory (Atomizer)	Anesthesiology	Class 1	868.5640	2021-01-28
CAP	Monitor, Airway Pressure (Includes Gauge And/Or Alarm)	Anesthesiology	Class 2	868.2600	2014-07-28
KYR	Bag, Ice	General Hospital	Class 1	880.6050	2007-06-27
IRT	Pad, Heating, Powered	Physical Medicine	Class 2	890.5740	2001-12-20
BYH	Drain, Tee (Water Trap)	Anesthesiology	Class 1	868.5995	2007-06-26
LYG	Massager, Therapeutic, Manual	Physical Medicine	Class 1	890.5660	2007-06-26
BYG	Mask, Oxygen	Anesthesiology	Class 1	868.5580	2007-06-26
IPF	Stimulator, Muscle, Powered	Physical Medicine	Class 2	890.5850	2014-07-28
CCK	Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase	Anesthesiology	Class 2	868.1400	2015-02-11
IME	Pack, Hot Or Cold, Reusable	Physical Medicine	Class 1	890.5700	2007-06-26
CAH	Filter, Bacterial, Breathing-Circuit	Anesthesiology	Class 2	868.5260	2024-12-03
BTC	Bag, Reservoir	Anesthesiology	Class 1	868.5320	2007-06-26
CAT	Cannula, Nasal, Oxygen	Anesthesiology	Class 1	868.5340	2007-06-27

Official Correspondent

No official correspondent registered.

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
3021284283	BESMED HEALTH BUSINESS CORP.-Chiayi	Dalin Township Chiayi, TW

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K122948	Gemore Technology Co, Ltd.	GEM-STIM COMBO STIMULATOR	2012-12-21
K033455	Biomedical Life Systems, Inc.	ELECTRO-NERVE STIMULATOR TENS, MODEL BMLS03-5	2004-01-15
K810593	Medical Devices, Inc.	NEUROPAC ULTRA I	1981-03-13
K883982	Iberhospitex, S.A.	DRENOVAC	1989-02-23
K163485	Adherium (Nz), Ltd.	SmartTouch	2017-08-30

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0019-2011	Atrium Medical Corporation	1	HydraGlide Silicone Chest Tube Catheter, 24 Fr Straight Product Code 14124
Z-0020-2011	Atrium Medical Corporation	1	HydraGlide Silicone Chest Tube Catheter, 32 Fr Straight Product Code 14132
Z-0039-2010	Unomedical	2	Infant Manual Pulmonary Resuscitator with reservoir bag, face mask & Gas sampling elbow. Product ID # 5801, 12-8713, 732-E, and 2206. Packaged under the name of Dynarex, Evergreen, Mada and Hospitak. Recalled codes may be identified by examining the patient valve housing immediately below the right-angle exhalation port, where the retention ring should be visible. MPR units with a clear or transparent ring, as well as those where no ring can be seen, should be returned. MPR units with a blue retention ring are not affected and do not need to be returned.
Z-0040-2010	Unomedical	2	Pediatric Manual Pulmonary Resuscitator with reservoir bag, face mask & Gas sampling elbow. Product ID #s: 5804; 12-8709, 727-E; 727MM, 2203. Packaged under the name of Dynarex, Evergreen, Mada and Hospitak.
Z-0041-2010	Unomedical	2	Adult Manual Pulmonary Resuscitator with reservoir tube, face mask & Gas Sampling elbow. Product ID # 5807; 12-8703, 723-E (Foreign Distribution only), 723MM. Packaged under the name of Dynarex and Evergreen.

Similar Registrations

Registration Number	Establishment Name	Location
2183890	UNIPOWER CORP.	Minnetonka, MN, US
3038562397	Respironics Medical Products (Shenzhen) Co., Ltd.	Shenzhen Guangdong, CN
9614485	NDD MEDIZINTECHNIK AG	ZURICH, CH
3012309966	ENGLERT GMBH & CO. KG	Wertheim Baden-Wurttemberg, DE
3010370454	SENSATRONIC GMBH	Wismar Mecklenburg-Western Pomerania, DE

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9710567. Last updated year: 2026. Please use registration number 9710567 when referencing this establishment in official correspondence.