Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3016734145

FEI Number

3016734145

Entity Name

CREATE BIOTECH CO., LTD.

City/State/Country

Taoyuan City, TW

Establishment Address

No. 68, Gong 7th Rd., Longtan Dist.,, Taoyuan City 32559, TW

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Create Biotech Co., Ltd. (Owner Number: 10068993)

Owner / Operator Contact Address

No. 68, Gong 7th Rd., Longtan Dist.,, Taoyuan City, TW-NOTA 32559, TW

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered 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 Suction Catheter 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

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
BSY	Catheters, Suction, Tracheobronchial	Anesthesiology	Class 1	868.6810	2020-04-14
BYH	Drain, Tee (Water Trap)	Anesthesiology	Class 1	868.5995	2020-04-14
CAE	Airway, Oropharyngeal, Anesthesiology	Anesthesiology	Class 1	868.5110	2020-04-14
JOL	Catheter And Tip, Suction	General Hospital	Class 2	880.6740	2020-04-14
NNZ	System, Urine Drainage, Closed, For Non-Indwelling Catheter, Non-Sterile	Gastroenterology, Urology	Class 1	876.5250	2022-08-02
BSJ	Mask, Gas, Anesthetic	Anesthesiology	Class 1	868.5550	2020-04-14
BTC	Bag, Reservoir	Anesthesiology	Class 1	868.5320	2022-06-27
EYJ	Holder, Ureteral Catheter	Gastroenterology, Urology	Class 1	876.5130	2023-10-23
NNW	Bag, Urine Collection, Leg, For External Use, Non-Sterile	Gastroenterology, Urology	Class 1	876.5250	2022-08-02
KGB	Mask, Oxygen, Non-Rebreathing	Anesthesiology	Class 1	868.5570	2020-04-14
CCQ	Nebulizer, Medicinal, Non-Ventilatory (Atomizer)	Anesthesiology	Class 1	868.5640	2020-04-14
BTQ	Airway, Nasopharyngeal	Anesthesiology	Class 1	868.5100	2022-07-28
BXH	Gauge, Gas Pressure, Cylinder/Pipeline	Anesthesiology	Class 1	868.2610	2020-04-14
HFW	Clamp, Umbilical	Obstetrics/Gynecology	Class 2	884.4530	2022-04-06
BYF	Mask, Oxygen, Low Concentration, Venturi	Anesthesiology	Class 1	868.5600	2020-04-14
CCW	Laryngoscope, Rigid	Anesthesiology	Class 1	868.5540	2020-04-14
BZO	Set, Tubing And Support, Ventilator (W Harness)	Anesthesiology	Class 1	868.5975	2020-05-20
BZB	Catheter, Nasal, Oxygen	Anesthesiology	Class 1	868.5350	2020-04-14

Official Correspondent

JOU-HSUAN HUANG

US Agent Details

Stephan Toupin Business: Dawa Medical Email: stoupin@dawamedical.com Phone: (786) 7311159

Related Public Records

Same Entity

Create Biotech Co., Ltd.

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

View Entity Profile →

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.
Z-0007-2013	Invuity, Inc.	2	BriteField illuminated Suction Device; Model numbers 8Fr, 10Fr and 12Fr, Kit (included 8Fr, 10Fr and 12Fr and a sterilization tray. The Invuity Brite Field Illuminated Suction Device is intended to aspirate from the surgical site and to provide illumination from a high intensity light source.
Z-0144-2024	Covidien	1	Stolen McGRATH MAC Video Laryngoscopes, REF: 301-000-000
Z-0168-2024	Covidien	1	McGrath Mac 2, Disposable Laryngoscope Blade, REF: 350-017-000, Sterile EO, Rx Only
Z-0169-2024	Covidien	1	McGrath Mac 2, Disposable Laryngoscope Blade, REF: 350-084-000, Sterile EO, Rx Only

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3016734145. Last updated year: 2026. Please use registration number 3016734145 when referencing this establishment in official correspondence.