Skip to the page

Data / Medical devices / China / Tylenol Medical Instruments Co., Ltd.

Tylenol Medical Instruments Co., Ltd.: FDA-registered device maker in Zhongshan Guangdong, China, 1 510(k) clearance

Tylenol Medical Instruments Co., Ltd. is registered with the FDA (registration 3013513837) in Zhongshan Guangdong, China. It lists 15 device types. The FDA files 1 510(k) clearance under its listings, the newest dated February 6, 2019. Registered through 2026. FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

FDA registration number
3013513837
Address
3rd Floor, No.10, Xinhua Road, Sanjiao Town, Zhongshan Guangdong, China, 528445
Owner or operator
Tylenol Medical Instruments Co., Ltd. (10057256)
Roles
Contract manufacturer, Manufacturer
First device listed
March 13, 2018
Registered through
2026
Brand names listed
AIRWAY, NASOPHARYNGEAL, AIRWAY, OROPHARYNGEAL, ANESTHETIC MASK, Aerosol Mask, model Adult Standard, Pediatric Standard, Adult Elongated, Pediatric Elongated, MASS SPECTROMETRY MONITORING LINE CONONECTORS, Multi-vent Masks, Nasal Oxygen Cannulas, Non-rebreath Masks and more

Devices it lists

DeviceProduct codeClassRoleSource
Accessory, Surgical ApparelLYU1Contract manufacturer, Manufactureraccessdata.fda.gov
Airway, NasopharyngealBTQ1Contract manufacturer, Manufactureraccessdata.fda.gov
Airway, Oropharyngeal, AnesthesiologyCAE1Contract manufacturer, Manufactureraccessdata.fda.gov
Analyzer, Gas, Carbon-Dioxide, Gaseous-PhaseCCK2Contract manufacturer, Manufactureraccessdata.fda.gov
Bag, Urine Collection, Leg, For External Use, SterileFAQ1Contract manufacturer, Manufactureraccessdata.fda.gov
Cannula, Nasal, OxygenCAT1Contract manufacturer, Manufactureraccessdata.fda.gov
Catheter And Tip, SuctionJOL2Contract manufactureraccessdata.fda.gov
Catheters, Suction, TracheobronchialBSY1Contract manufacturer, Manufactureraccessdata.fda.gov
Collector, Urine, Pediatric, For Indwelling CatheterFFH2Contract manufacturer, Manufactureraccessdata.fda.gov
Mask, Gas, AnestheticBSJ1Contract manufacturer, Manufactureraccessdata.fda.gov
Mask, OxygenBYG1Contract manufacturer, Manufactureraccessdata.fda.gov
Mask, Oxygen, Low Concentration, VenturiBYF1Contract manufacturer, Manufactureraccessdata.fda.gov
Mask, Oxygen, Non-RebreathingKGB1Contract manufacturer, Manufactureraccessdata.fda.gov
Respirator, SurgicalMSH2Contract manufacturer, Manufactureraccessdata.fda.gov
Tube, Aspirating, Flexible, ConnectingBYY2Contract manufacturer, Manufactureraccessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
February 6, 2019K181981CO2 Sampling LineCCKSubstantially EquivalentTylenol Medical Instruments Co., Ltd.accessdata.fda.gov

Compare with other makers

Updated February 6, 2019. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.