FDA Registration
Active
🇹🇼 Taiwan
CREATE BIOTECH CO., LTD.
Reg #: 3016734145
·
FEI: 3016734145
·
Expires 2026
Products
33
Proprietary Names
124
Establishment Types
1
Classifications
33
Registration Details
- Registration Name
- CREATE BIOTECH CO., LTD.
- Registration Number
- 3016734145
- FEI Number
- 3016734145
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- No. 68, Gong 7th Rd., Longtan Dist.,
- City
- Taoyuan City
- Country
- TW
Owner / Operator
- Firm Name
- Create Biotech Co., Ltd.
- Operator Number
- 10068993
- Address
- No. 68, Gong 7th Rd., Longtan Dist.,
- City
- Taoyuan City
- State
- TW-NOTA
- Postal Code
- 32559
- Country
- TW
- Correspondent
- JOU-HSUAN HUANG
US Agent
- Business Name
- Dawa Medical
- Contact Name
- Stephan Toupin
- Address
- 7320 NW 12th Street, Suite 103 Miami, FL 33126
- City
- Doral
- State
- FL
- ZIP
- 33126
- Country
- US
- [email protected]
- Phone
- 786 7311159
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Catheters, Suction, Tracheobronchial | BSY | Class 1 | Anesthesiology | No | 2020-04-14 |
| Drain, Tee (Water Trap) | BYH | Class 1 | Anesthesiology | No | 2020-04-14 |
| Airway, Oropharyngeal, Anesthesiology | CAE | Class 1 | Anesthesiology | No | 2020-04-14 |
| Catheter And Tip, Suction | JOL | Class 2 | General Hospital | No | 2020-04-14 |
| System, Urine Drainage, Closed, For Non-Indwelling Catheter, Non-Sterile | NNZ | Class 1 | Gastroenterology, Urology | No | 2022-08-02 |
| Mask, Gas, Anesthetic | BSJ | Class 1 | Anesthesiology | No | 2020-04-14 |
| Bag, Reservoir | BTC | Class 1 | Anesthesiology | No | 2022-06-27 |
| Holder, Ureteral Catheter | EYJ | Class 1 | Gastroenterology, Urology | No | 2023-10-23 |
| Bag, Urine Collection, Leg, For External Use, Non-Sterile | NNW | Class 1 | Gastroenterology, Urology | No | 2022-08-02 |
| Mask, Oxygen, Non-Rebreathing | KGB | Class 1 | Anesthesiology | No | 2020-04-14 |
| Nebulizer, Medicinal, Non-Ventilatory (Atomizer) | CCQ | Class 1 | Anesthesiology | No | 2020-04-14 |
| Airway, Nasopharyngeal | BTQ | Class 1 | Anesthesiology | No | 2022-07-28 |
| Gauge, Gas Pressure, Cylinder/Pipeline | BXH | Class 1 | Anesthesiology | No | 2020-04-14 |
| Clamp, Umbilical | HFW | Class 2 | Obstetrics/Gynecology | No | 2022-04-06 |
| Mask, Oxygen, Low Concentration, Venturi | BYF | Class 1 | Anesthesiology | No | 2020-04-14 |
| Laryngoscope, Rigid | CCW | Class 1 | Anesthesiology | No | 2020-04-14 |
| Set, Tubing And Support, Ventilator (W Harness) | BZO | Class 1 | Anesthesiology | No | 2020-05-20 |
| Catheter, Nasal, Oxygen | BZB | Class 1 | Anesthesiology | No | 2020-04-14 |
| Condenser, Heat And Moisture (Artificial Nose) | BYD | Class 1 | Anesthesiology | No | 2020-04-14 |
| Cannula, Nasal, Oxygen | CAT | Class 1 | Anesthesiology | No | 2020-04-14 |
| Stylet, Tracheal Tube | BSR | Class 1 | Anesthesiology | No | 2020-12-09 |
| Enteral Administration Kit (Adult & Pediatric) | PRM | Class 2 | Gastroenterology, Urology | No | 2022-10-27 |
| Circuit, Breathing (W Connector, Adaptor, Y Piece) | CAI | Class 1 | Anesthesiology | No | 2020-04-10 |
| Bottle, Collection, Vacuum | KDQ | Class 2 | General Hospital | No | 2022-06-27 |
| Accessories, Catheter | KGZ | Class 1 | General, Plastic Surgery | No | 2020-12-17 |
| Humidifier, Non-Direct Patient Interface (Home-Use) | KFZ | Class 1 | Anesthesiology | No | 2021-11-22 |
| Device, Fixation, Tracheal Tube | CBH | Class 1 | Anesthesiology | No | 2020-04-14 |
| Mask, Oxygen | BYG | Class 1 | Anesthesiology | No | 2020-04-14 |
| Transducer, Gas Pressure, Differential | BYR | Class 1 | Anesthesiology | No | 2022-06-27 |
| Connector, Airway (Extension) | BZA | Class 1 | Anesthesiology | No | 2020-04-14 |
| Flowmeter, Calibration, Gas | BXY | Class 1 | Anesthesiology | No | 2020-04-14 |
| Adaptor, Holder, Syringe | IQG | Class 1 | Physical Medicine | No | 2023-01-12 |
| Transducer, Gas Flow | BXP | Class 1 | Anesthesiology | No | 2023-06-07 |
Proprietary Names
Closed Suction Catheter
Suction Catheter
Mucus Extractor
Oxygen Tube Water Trap
Sampling Line Water Trap
Oxygen Concentrator Water Trap
Water Trap
Oropharyngeal Airway
Laryngeal Mask
Guedel Airway
Laryngeal Mask Airway
Yankauer Suction
Suction Connecting Tube
Yankauer Suction Handle
Urine Drainage Catheter
Inflatable Anesthesia Mask
Anesthetic Mask
Silicone Anesthetic Gas Mask
Silicone Anesthesia Mask
Anesthesia Mask
Anesthetic Gas Mask
Breathing Bag
Test Lung
Reservoir Bag
Foley Catheter Holder
Drainage Bag
High-Concentration Oxygen Mask
Non-rebreathing Oxygen Mask
Non-rebreathing Mask
NEBULIZER
Nebulizer Kit
Nebulizer Mask
Nasal Airway
Nesopharyngeal Airway
Manometer Gauge
Manometer
Pressure Manometer
Umbilical Cord Clamp
Venturi Mask
Venturi Oxygen Mask
Air-entrainment Oxygen Mask
Oxygen T-piece
Multi-Vent Oxygen Mask
Laryngoscope
Breathing Tube
Neonatal CPAP System
CPAP Tubing
CPAP System
Headgear
Neonatal CPAP Tubing
Oxygen Catheter
Nasal Catheter
Oxygen Nasal Catheter
Artificial Nose
Heat and Moisture Exchange
HME
Oxygen Nasal Cannula
High Flow Nasal Cannula
Oxygen Cannula
Nasal CPAP Prongs
Medium Flow Nasal Cannula
Nasal Cannula
Nasal CPAP Cannula
Bubble CPAP Nasal Cannula
Nasal Prongs
NCPAP Nasal Cannula
Gas Monitoring Line
EtCO2 Nasal Cannula
Tracheal Tube Introducer - Stylet
Tracheal Tube Introducer - Bougie
Stomach Tube(Gastric Calibration Tube)
Breathing Limb
Reusable Manifold
Breathing Circuit and Accessories
Manifold
Resuscitation Breathing Circuit
BIPAP Breathing Circuit
Catheter Mount
Breathing Circuit
Breathing System and Accessories
Water Bubble Generator
Exhalation Valve
CPAP Breathing Circuit
Breathing System Connector
Disposable Chamber
Universal Single Limb Use Patient Circuit
Universal Dual Limb Use Patient Circuit
Suction Liner
Disposable Waste Liquid Collector
Disposable Suction Liner Bag
Disposable Waste Liquid Suction Bag
Disposable Waste Liquid Bottle
Humidifier
Endotracheal Tube Holder
Tracheal Tube Holder
Airway Holder
Endotracheal Tube Fixation Device
Airway Fixation Device
Tracheal Tube Fixation Device
Tracheostomy Tube Holder
Cannula Holder
Nasal CPAP Mask
CPAP Oxygen Mask
Medium Concentration Oxygen Mask
Simple Oxygen Mask
Nasal Mask
Oxygen Mask
BIPAP Oxygen Mask
EtCO2 Oxygen Mask
Differential Pressure Flow Transducer
Flow Transducer
Double Swivel Elbow Connector
Elbow Connector
Swivel Oxygen Connector
Oxygen Tube Adapter
Airway Connector
Catheter Mount and Connectors
Oxygen Connector
Airway Adapter
Differential Pressure Flow Meter
Flow Meter
Flowmeter
Syringe Connecting Tube and Adapter
Flow Sensor
Establishment Types
Manufacture Medical Device