FDA Registration
Active
🇹🇼 Taiwan
Besmed Health Business Corporation
Reg #: 9710567
·
FEI: 3003256355
·
Expires 2026
Products
47
Proprietary Names
119
Establishment Types
2
Classifications
47
Registration Details
- Registration Name
- Besmed Health Business Corporation
- Registration Number
- 9710567
- FEI Number
- 3003256355
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- No. 5, Lane 116, Wu-Kong 2nd Rd. Wu-ku District
- City
- New Taipei City
- Country
- TW
Regulatory Submissions
- 510(k) Number
- K031374
Owner / Operator
- Firm Name
- BESMED HEALTH BUSINESS CORP.
- Operator Number
- 9047866
- Address
- No. 5, Lane 116, Wu-Kong 2nd Rd., Wu-ku District
- City
- New Taipei City
- State
- TW-TPE
- Postal Code
- 24888
- Country
- TW
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Transducer, Gas Flow | BXP | Class 1 | Anesthesiology | No | 2020-04-29 |
| Irrigator, Powered Nasal | KMA | Class 1 | Ear, Nose, Throat | No | 2015-08-24 |
| Stimulator, Nerve, Transcutaneous, For Pain Relief | GZJ | Class 2 | Neurology | No | 2011-09-13 |
| Catheter, Ventricular, General & Plastic Surgery | GBS | Class 1 | General, Plastic Surgery | No | 2015-01-20 |
| Clip, Nose | BXJ | Class 1 | Anesthesiology | No | 2007-06-26 |
| Spirometer, Therapeutic (Incentive) | BWF | Class 2 | Anesthesiology | No | 2014-05-12 |
| Attachment, Breathing, Positive End Expiratory Pressure | BYE | Class 2 | Anesthesiology | No | 2016-06-06 |
| Ventilator, Emergency, Manual (Resuscitator) | BTM | Class 2 | Anesthesiology | No | 2001-09-26 |
| Apparatus, Suction, Single Patient Use, Portable, Nonpowered | GCY | Class 1 | General, Plastic Surgery | No | 2007-06-26 |
| Nebulizer (Direct Patient Interface) | CAF | Class 2 | Anesthesiology | No | 2015-07-07 |
| Circuit, Breathing (W Connector, Adaptor, Y Piece) | CAI | Class 1 | Anesthesiology | No | 2007-06-26 |
| Regulator, Pressure, Gas Cylinder | CAN | Class 1 | Anesthesiology | No | 2021-01-28 |
| Meter, Peak Flow, Spirometry | BZH | Class 2 | Anesthesiology | No | 2018-01-12 |
| Cup, Menstrual | HHE | Class 2 | Obstetrics/Gynecology | No | 2021-03-02 |
| Pack, Hot Or Cold, Disposable | IMD | Class 1 | Physical Medicine | No | 2007-06-26 |
| Compressor, Air, Portable | BTI | Class 2 | Anesthesiology | No | 2017-12-20 |
| Gauge, Gas Pressure, Cylinder/Pipeline | BXH | Class 1 | Anesthesiology | No | 2021-07-13 |
| Mask, Gas, Anesthetic | BSJ | Class 1 | Anesthesiology | No | 2007-06-26 |
| Tubing, Pressure And Accessories | BYX | Class 1 | Anesthesiology | No | 2007-06-27 |
| Massager, Therapeutic, Electric | ISA | Class 1 | Physical Medicine | No | 2019-01-16 |
| Catheter, Irrigation | GBX | Class 1 | General, Plastic Surgery | No | 2015-08-24 |
| Humidifier, Non-Direct Patient Interface (Home-Use) | KFZ | Class 1 | Anesthesiology | No | 2007-06-26 |
| Calibrator, Volume, Gas | BXW | Class 1 | Anesthesiology | No | 2024-09-30 |
| Nebulizer, Medicinal, Non-Ventilatory (Atomizer) | CCQ | Class 1 | Anesthesiology | No | 2021-01-28 |
| Monitor, Airway Pressure (Includes Gauge And/Or Alarm) | CAP | Class 2 | Anesthesiology | No | 2014-07-28 |
| Bag, Ice | KYR | Class 1 | General Hospital | No | 2007-06-27 |
| Pad, Heating, Powered | IRT | Class 2 | Physical Medicine | No | 2001-12-20 |
| Drain, Tee (Water Trap) | BYH | Class 1 | Anesthesiology | No | 2007-06-26 |
| Massager, Therapeutic, Manual | LYG | Class 1 | Physical Medicine | No | 2007-06-26 |
| Mask, Oxygen | BYG | Class 1 | Anesthesiology | No | 2007-06-26 |
| Stimulator, Muscle, Powered | IPF | Class 2 | Physical Medicine | No | 2014-07-28 |
| Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase | CCK | Class 2 | Anesthesiology | No | 2015-02-11 |
| Pack, Hot Or Cold, Reusable | IME | Class 1 | Physical Medicine | No | 2007-06-26 |
| Filter, Bacterial, Breathing-Circuit | CAH | Class 2 | Anesthesiology | No | 2024-12-03 |
| Bag, Reservoir | BTC | Class 1 | Anesthesiology | No | 2007-06-26 |
| Cannula, Nasal, Oxygen | CAT | Class 1 | Anesthesiology | No | 2007-06-27 |
| Condenser, Heat And Moisture (Artificial Nose) | BYD | Class 1 | Anesthesiology | No | 2007-06-26 |
| Laryngoscope, Rigid | CCW | Class 1 | Anesthesiology | No | 2007-06-26 |
| Strap, Head, Gas Mask | BTK | Class 1 | Anesthesiology | No | 2007-06-26 |
| Mouthpiece, Breathing | BYP | Class 1 | Anesthesiology | No | 2007-06-26 |
| Flowmeter, Calibration, Gas | BXY | Class 1 | Anesthesiology | No | 2013-06-27 |
| Brush, Scrub, Operating-Room | GEC | Class 1 | General, Plastic Surgery | No | 2007-06-26 |
| Mask, Oxygen, Low Concentration, Venturi | BYF | Class 1 | Anesthesiology | No | 2007-06-26 |
| Pack, Heat, Moist | IMA | Class 1 | Physical Medicine | No | 2007-06-27 |
| Airway, Nasopharyngeal | BTQ | Class 1 | Anesthesiology | No | 2022-10-17 |
| Mask, Oxygen, Non-Rebreathing | KGB | Class 1 | Anesthesiology | No | 2007-06-26 |
| Airway, Oropharyngeal, Anesthesiology | CAE | Class 1 | Anesthesiology | No | 2007-06-26 |
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 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
BESMED ARTIFICIAL NOSE
BESMED LARYNGOSCOPE SET
Bonnet
Nasal mask
BESMED HEAD STRAP
BESMED MOUTHPIECE
BESMED BITE BLOCK
MOUTHPIECE
Besmed Oxygen Liter Meter
BESMED SURGICAL BRUSH
BESMED VENTURI MASK
Besmed Jet Nebulizer Bottle Set
BESMED BIOTHERMOPHORE
Besmed Nasopharyngeal airway
Besmed Volumetric Incentive Spirometer
BESMED CRR POCKET MASK
BESMED HI-OXYGEN MASK
GUEDEL AIRWAY
BESMED BERMAN
LARYNGEAL AIRWAY MASK
Establishment Types
Manufacture Medical Device
Export Device to the United States But Perform No Other Operation on Device