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Data / Medical devices / Hong Kong / Vincent Medical Manufacturing. Co., Ltd.

Vincent Medical Manufacturing. Co., Ltd.: FDA-registered device maker in Kowloon, Hong Kong, 21 510(k) clearances

Vincent Medical Manufacturing. Co., Ltd. is registered with the FDA (registration 1000604079) in Kowloon, Hong Kong. It lists 45 device types. The FDA files 21 510(k) clearances under its listings, the newest dated September 24, 2025. Registered through 2026. FDA data exported November 3, 2026.

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FDA registration number
1000604079
Address
Flat/Rm B2,7/F,hang Fung Industrial Building Phase 2,2G Hok Yuen Street,hung Hom, Kowloon, Hong Kong, --
Owner or operator
VINCENT MEDICAL MANUFACTURING. CO., LTD. (10041038)
Roles
Contract manufacturer, Exporter to the US, Repackager or relabeler
First device listed
June 14, 2012
Registered through
2026
Brand names listed
1.5m Adult, Reusable, Hytrel, Bag Tube, with 22 Male Connector, Adult (22mm) Single limb Smoothbore + 3 Way exhalation valve (VM version), Adult (22mm) Single limb corrugated + 3 Way exhalation valve (VM version), Air Cushion Masks for neonate, infant, pediatric, child, small adult, large adult, BAG TUBE, ADULT, REUSABLE, HYTREL, 1.5m, Inpsired Medical Adult Anaesthesia Breathing System including drapable/expandable tubing, connectors, spare limb, Inpsired Medical Prediatric Anaesthesia Breathing System including hoses, connectors, spare limb, Inspired Medical Limbo Circuit iincluding connectors and more

Devices it lists

DeviceProduct codeClassRoleSource
Analyzer, Gas, Carbon-Dioxide, Gaseous-PhaseCCK2Exporter to the USaccessdata.fda.gov
Analyzer, Gas, Desflurane, Gaseous-Phase (Anesthetic Concentration)NHO2Exporter to the USaccessdata.fda.gov
Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration)CBQ2Exporter to the USaccessdata.fda.gov
Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.)CBS2Exporter to the USaccessdata.fda.gov
Analyzer, Gas, Isoflurane, Gaseous-Phase (Anesthetic Concentration)NHQ2Exporter to the USaccessdata.fda.gov
Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.)CBR2Exporter to the USaccessdata.fda.gov
Analyzer, Gas, Oxygen, Gaseous-PhaseCCL2Exporter to the USaccessdata.fda.gov
Analyzer, Gas, Sevoflurane, Gaseous-Phase (Anesthetic Concentration)NHP2Exporter to the USaccessdata.fda.gov
Anesthesia Breathing Circuit Kit (Adult & Pediatric)OFP1Exporter to the USaccessdata.fda.gov
Apparatus, Traction, Non-PoweredHST1Exporter to the USaccessdata.fda.gov
Bag, ReservoirBTC1Exporter to the USaccessdata.fda.gov
Circuit, Breathing (W Connector, Adaptor, Y Piece)CAI1Exporter to the USaccessdata.fda.gov
Computer, Oxygen-UptakeBZL2Exporter to the USaccessdata.fda.gov
Condenser, Heat And Moisture (Artificial Nose)BYD1Exporter to the USaccessdata.fda.gov
Connector, Airway (Extension)BZA1Exporter to the USaccessdata.fda.gov
Conserver, OxygenNFB2Exporter to the USaccessdata.fda.gov
Continuous, Ventilator, Home UseNOU2Exporter to the USaccessdata.fda.gov
Cover, CastKIA1Exporter to the USaccessdata.fda.gov
Device, Positive Pressure Breathing, IntermittentNHJ2Exporter to the USaccessdata.fda.gov
Filter, Bacterial, Breathing-CircuitCAH2Exporter to the USaccessdata.fda.gov
Generator, Oxygen, PortableCAW2Exporter to the USaccessdata.fda.gov
Heater, Breathing System W/Wo Controller (Not Humidifier Or NebulizerBZE2Exporter to the USaccessdata.fda.gov
Infusor, Pressure, For I.V. BagsKZD1Exporter to the USaccessdata.fda.gov
Injector And Syringe, AngiographicDXT2Exporter to the USaccessdata.fda.gov
Injector, Contrast Medium, AutomaticIZQ2Exporter to the USaccessdata.fda.gov
Instrument, Manual, Surgical, General UseMDM1Exporter to the USaccessdata.fda.gov
Instrument, Surgical, DisposableKDC1Exporter to the USaccessdata.fda.gov
Mask, OxygenBYG1Exporter to the USaccessdata.fda.gov
Meter, Peak Flow, SpirometryBZH2Exporter to the USaccessdata.fda.gov
Monitor, Airway Pressure (Includes Gauge And/Or Alarm)CAP2Exporter to the USaccessdata.fda.gov
Mouthpiece, BreathingBYP1Exporter to the USaccessdata.fda.gov
Nebulizer (Direct Patient Interface)CAF2Exporter to the USaccessdata.fda.gov
Needle, Suturing, DisposableGAB1Exporter to the USaccessdata.fda.gov
Pump, Portable, Aspiration (Manual Or Powered)BTA2Exporter to the USaccessdata.fda.gov
Regulator, Pressure, Gas CylinderCAN1Contract manufacturer, Repackager or relabeleraccessdata.fda.gov
Scalpel, One-PieceGDX1Exporter to the USaccessdata.fda.gov
Set, Tubing And Support, Ventilator (W Harness)BZO1Exporter to the USaccessdata.fda.gov
Spirometer, DiagnosticBZG2Exporter to the USaccessdata.fda.gov
Spirometer, Monitoring (W/Wo Alarm)BZK2Exporter to the USaccessdata.fda.gov
Splint, TractionHSP1Exporter to the USaccessdata.fda.gov
Transilluminator, Battery-PoweredHJN1Exporter to the USaccessdata.fda.gov
Tubing, Fluid DeliveryFPK2Exporter to the USaccessdata.fda.gov
Tubing, Pressure And AccessoriesBYX1Exporter to the US, Repackager or relabeleraccessdata.fda.gov
Ventilator, Continuous, Facility UseCBK2Exporter to the USaccessdata.fda.gov
Warmer, Infant RadiantFMT2Exporter to the USaccessdata.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
September 24, 2025K252689MEDRAD Centargo CT Injection System; MEDRAD Centargo Day Set; MEDRAD Centargo Patient Line; MEDRAD Centargo Replacement Spike; MEDRAD ISI2 Module (ISI2)IZQSubstantially EquivalentImaxeon Pty, Ltd.accessdata.fda.gov
May 8, 2025K251133AVEA disposable expiratory filter/water trap (11790)CBKSubstantially EquivalentTelesair, Inc.accessdata.fda.gov
November 5, 2024K241849MEDRAD Centargo CT Injection System; MEDRAD Centargo Day Set; MEDRAD Centargo Patient Line; MEDRAD Centargo Replacement Spike; MEDRAD ISI2 Module (ISI2)IZQSubstantially EquivalentImaxeon Pty, Ltd.accessdata.fda.gov
January 29, 2021K202970Ventway SparrowCBKSubstantially EquivalentInovytech Medical Solutions , Ltd.accessdata.fda.gov
April 30, 2018K171678Gas Sampling Line, Coextruded, 2m/7ft, 10/pkg, Disposable/ 100/pkg, Disposable, Gas Sampling Line, Coextruded, 2.5m/8ft, 10/pkg, Disposable, Gas Sampling Line, Coextruded, 3m/10ft, 10/pkg, Disposable/ 100/pkg, Disposable, Gas Sampling Line, Coextruded, 6m/20ft, 5/pkg, DisposableCCKSubstantially EquivalentVyaire Medical, Inc.accessdata.fda.gov
April 7, 2017K162877VOCSN Unified Respiratory SystemCBKSubstantially EquivalentVentec Life Systems, Inc.accessdata.fda.gov
September 10, 2013K123896CCS-200 SPIROMETERBZGSubstantially EquivalentBenson Medical Instruments Co.accessdata.fda.gov
August 2, 2013K131517MEDRAD TWIST & GO HIGH PRESSURE CONNECTOR TUBINGFPKSubstantially EquivalentMedrad, Inc. / Bayer Medical Care, Inc.accessdata.fda.gov
November 2, 2012K120642RESUSCITAIRE WITH AUTOBREATHFMTSubstantially EquivalentDraeger Medical Systems, Inc.accessdata.fda.gov
September 13, 2010K101380RXPEAKFLOWBZHSubstantially EquivalentNoble Marketingaccessdata.fda.gov
June 17, 2005K050456MEDRAD AVANTA FLUID MANAGEMENT INJECTION SYSTEMDXTSubstantially EquivalentMedrad, Inc.accessdata.fda.gov
May 25, 2005K051092DATEX-OHMEDA S/5 COMPACT AIRWAY MODULE (MODEL FAMILY E-CAIOVX) E-CAIOVX, E-CAIOV, E-CAIO, E-COVX, E-COV, E-CO & ACCESACCCCLSubstantially EquivalentGE Healthcareaccessdata.fda.gov
March 1, 2005K043120MIN-FILTER/S, UNI-FILTER JUNIOR, UNI-FILTER/S ANGLED AND UNI-FILTERCAHSubstantially EquivalentDatex-Ohmeda, Inc.accessdata.fda.gov
June 20, 2003K031653DATEX-OHMEDA HMEF 750CAHSubstantially EquivalentDatex-Ohmedaaccessdata.fda.gov
November 27, 2002K023641DATEX-OHMEDA HMEF MINICAHSubstantially EquivalentDatex-Ohmedaaccessdata.fda.gov
August 30, 2002K021265DATEX-OHMEDA HMEF 500CAHSubstantially EquivalentDatex-Ohmedaaccessdata.fda.gov
March 19, 1998K973532STEALTH, METERED DOSE INHALER (MDI) SPACER WITHOUT INTEGRAL ACTUATORCAFSubstantially EquivalentDhd Diemolding Healthcare Div.accessdata.fda.gov
November 13, 1996K964204ENGSTROM HMEF 1000CAHSubstantially EquivalentDatex Engstrom ABaccessdata.fda.gov
May 20, 1994K933902MOBLVAC IIIBTASubstantially EquivalentAeros Instruments, Inc.accessdata.fda.gov
March 19, 1984K834588OXYMIZER-PENDANTNFBSubstantially EquivalentChad Therapeutics, Inc.accessdata.fda.gov
April 2, 1983K830009OXYMIZERNFBSubstantially EquivalentChad Therapeutics, Inc.accessdata.fda.gov

Compare with other makers

Updated September 24, 2025. 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.