Data / Medical devices / China / Vincent Medical (dong Guan) Manufacturing Co., Ltd.

Vincent Medical (dong Guan) Manufacturing Co., Ltd.: FDA-registered device maker in Dong Guan City Guangdong, China, 1 510(k) clearance

Name: Vincent Medical (dong Guan) Manufacturing Co., Ltd. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Vincent Medical (dong Guan) Manufacturing Co., Ltd. is registered with the FDA (registration 3004050971) in Dong Guan City Guangdong, China. It lists 29 device types. The FDA files 1 510(k) clearance under its listings, the newest dated June 24, 1997. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3004050971
Address: 11 Shabu Street, Qiao Long District Tang Xia Town, Dong Guan City Guangdong, China, 523730
Owner or operator: VINCENT MEDICAL MANUFACTURING CO., LTD. (9051073)
Roles: Contract manufacturer, Contract sterilizer, Manufacturer
First device listed: July 29, 2003
Registered through: 2026
Brand names listed: Air Cushion Masks for neonate, infant, pediatric, child, small adult, large adult, Anesthesia breathing circuit kit (adult & pediatric), BAG TUBE, ADULT, REUSABLE, HYTREL, 1.5m, Disposable Surgical Light Handle Cover, Inspired Reusable Breathing Circuit, RW Resuscitaire, VentStar Heated/ Infinity ID Breathing Circuit Heated, VentStar humidifier chamber (N)

Devices it lists

Device	Product code	Class	Role	Source
Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase	CCK	2	Contract manufacturer	accessdata.fda.gov
Anesthesia Breathing Circuit Kit (Adult & Pediatric)	OFP	1	Contract manufacturer	accessdata.fda.gov
Bag, Reservoir	BTC	1	Contract manufacturer	accessdata.fda.gov
Circuit, Breathing (W Connector, Adaptor, Y Piece)	CAI	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Condenser, Heat And Moisture (Artificial Nose)	BYD	1	Contract manufacturer	accessdata.fda.gov
Connector, Airway (Extension)	BZA	1	Contract manufacturer	accessdata.fda.gov
Conserver, Oxygen	NFB	2	Contract manufacturer	accessdata.fda.gov
Cover, Cast	KIA	1	Contract manufacturer	accessdata.fda.gov
Device, Positive Pressure Breathing, Intermittent	NHJ	2	Contract manufacturer	accessdata.fda.gov
Filter, Bacterial, Breathing-Circuit	CAH	2	Contract manufacturer, Manufacturer	accessdata.fda.gov
Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer	BZE	2	Contract manufacturer	accessdata.fda.gov
Humidifier, Respiratory Gas, (Direct Patient Interface)	BTT	2	Contract manufacturer	accessdata.fda.gov
Infusor, Pressure, For I.V. Bags	KZD	1	Contract manufacturer	accessdata.fda.gov
Injector And Syringe, Angiographic	DXT	2	Contract manufacturer, Contract sterilizer	accessdata.fda.gov
Injector, Contrast Medium, Automatic	IZQ	2	Contract manufacturer	accessdata.fda.gov
Instrument, Manual, Surgical, General Use	MDM	1	Contract manufacturer	accessdata.fda.gov
Instrument, Surgical, Disposable	KDC	1	Contract manufacturer	accessdata.fda.gov
Light, Surgical, Accessories	FTA	2	Contract manufacturer	accessdata.fda.gov
Mask, Oxygen	BYG	1	Contract manufacturer	accessdata.fda.gov
Meter, Peak Flow, Spirometry	BZH	2	Contract manufacturer	accessdata.fda.gov
Monitor, Airway Pressure (Includes Gauge And/Or Alarm)	CAP	2	Contract manufacturer	accessdata.fda.gov
Mouthpiece, Breathing	BYP	1	Contract manufacturer	accessdata.fda.gov
Pump, Portable, Aspiration (Manual Or Powered)	BTA	2	Contract manufacturer	accessdata.fda.gov
Scalpel, One-Piece	GDX	1	Contract manufacturer	accessdata.fda.gov
Set, Tubing And Support, Ventilator (W Harness)	BZO	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Spirometer, Diagnostic	BZG	2	Contract manufacturer	accessdata.fda.gov
Tubing, Fluid Delivery	FPK	2	Contract manufacturer, Contract sterilizer	accessdata.fda.gov
Ventilator, Continuous, Facility Use	CBK	2	Contract manufacturer	accessdata.fda.gov
Warmer, Infant Radiant	FMT	2	Contract manufacturer	accessdata.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.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
June 24, 1997	K970102	FILTER	CAH	Substantially Equivalent	Promedic, Inc.	accessdata.fda.gov

Compare with other makers

Updated June 24, 1997. 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.