BEUDAMED
    FDA Registration Active 🇨🇳 China

    GaleMed (Xiamen) Co., Ltd.

    Reg #: 3006783791 · FEI: 3006783791 · Expires 2026
    View on FDA
    Products
    33
    Proprietary Names
    477
    Establishment Types
    3
    Classifications
    33

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    Registration Details

    Registration Name
    GaleMed (Xiamen) Co., Ltd.
    Registration Number
    3006783791
    FEI Number
    3006783791
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Xiamen Area of China (Fujian) Pilot Free Trade Zone, 39, Section 3, Haijing East Road, 361026 Fujian Province, China
    City
    XIAMEN Fujian
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K021742

    Owner / Operator

    Firm Name
    GaleMed Corporation
    Operator Number
    8043316
    Address
    87, LI-GONG 2ND RD.,
    City
    Wu-jia
    State
    Yilan
    Postal Code
    268
    Country
    TW

    US Agent

    Business Name
    ProMedic, LLC
    Contact Name
    Matt Dryden
    Address
    131 Bay Point Dr. NE, St. Petersburg, FL 33704, USA
    City
    Saint Petersburg
    State
    FL
    ZIP
    33704
    Country
    US
    Email
    [email protected]
    Phone
    239 3076060

    Products

    Device Name Product Code
    Filter, Bacterial, Breathing-Circuit CAH
    Spirometer, Monitoring (W/Wo Alarm) BZK
    Nebulizer (Direct Patient Interface) CAF
    Ventilator, Non-Continuous (Respirator) BZD
    Regulator, Pressure, Gas Cylinder CAN
    Attachment, Breathing, Positive End Expiratory Pressure BYE
    Gas, Collecting Vessel KGK
    Drain, Tee (Water Trap) BYH
    Ventilator, Emergency, Manual (Resuscitator) BTM
    Bag, Reservoir BTC
    Humidifier, Respiratory Gas, (Direct Patient Interface) BTT
    Clip, Nose BXJ
    Exerciser, Non-Measuring For Stroke Rehabilitation PKS
    Mask, Gas, Anesthetic BSJ
    Cannula, Nasal, Oxygen CAT
    Circuit, Breathing (W Connector, Adaptor, Y Piece) CAI
    Set, Tubing And Support, Ventilator (W Harness) BZO
    Transducer, Gas Pressure BXO
    Sv70 Ventilator MNT
    Mask, Oxygen BYG
    Ventilator, Continuous, Facility Use CBK
    Monitor, Airway Pressure (Includes Gauge And/Or Alarm) CAP
    Ventilator, Emergency, Powered (Resuscitator) BTL
    Mouthpiece, Breathing BYP
    Connector, Airway (Extension) BZA
    Cardiopulmonary Resuscitation Aid Kit OEV
    Condenser, Heat And Moisture (Artificial Nose) BYD
    Airway, Oropharyngeal, Anesthesiology CAE
    Exerciser, Non-Measuring ION
    Tubing, Pressure And Accessories BYX
    Valve, Non-Rebreathing CBP
    Resuscitator, Manual, Non Self-Inflating NHK
    Strap, Head, Gas Mask BTK

    Proprietary Names

    EXHALOMETER GaleMed Large Volume Nebulizer Neb-Easy Nebulizer GALEMED NEBULIZER SET GALEMED LARGE VOLUME RF1 Nebulizer w/Valve T Kit, 22F, 22M RF1 Nebulizer w/Valve T Kit, 22M, 22M Neb.Easy Nebulizer w/Mouth Piece, Tube Neb.Easy AM-1 Mask, Infant w/Tube Neb.Easy AM-1 Mask, Adult w/Tube RF1 Nebulizer w/ATV, 1.6M Tube Neb.Easy AM-1 Mask, Child w/Tube Bravo II Bravo Disposable Tail-End Valve VentStar Resuscitaire CEU Galemed Gas sampling line Gas Sampling Line, 300cm, R1 Connector Sylent Sylent NE water trap Reusable water trap Water trap set Hybrid Complete System Dispo-BAG Manual Resuscitation Bag Disposable PEEP Valve DISPO-BAG Manual Resuscitation Bag with Disposable PEEP Valve Dispo-Bag Manual Resuscitator Adj PEEP Valve, 7.5cmH2O, 22F PEEP Valve, 5~20 cmH2O, 30F PEEP Valve, 2.5~10cmH2O, 30F DispoBag, Adult w/Pop-Off, Mask Adj. PEEP Valve, 5~20cmH2O, 22M Disposable Peep Valve 10cmH O, 30mmID Yellow PEEP Valve, 5~20cmH2O, 22F Disposable Peep Valve 7.5cmH O, 30mmID Green Disposable Peep Valve 5cmH O, 30mmID Blue Latex-Free Breathing Bag 2L Latex-Free Breathing Bag 2L Latex-Free Breathing Bag 3L Latex-Free Breathing breathing bag Silicone Breathing Bag Latex Breathing Bag VentStar Bag Set 120 2L NON-LATEX BREATHING BAG ID Bag Set 150 ID Breathing Bag Set Silicone Breathing Bag 2L w/loop end Latex-Free Breathing Bag 3L VentStar Bag Set Latex-Free Breathing Bag 1L VentStar breathing bag Set 150 Silicone Breathing Bag, 3L Latex-Free Breathing Bag 1L Silicone Breathing Bag, 2L Latex-Free Breathing Bag 0.5L Silicone Breathing Bag, 0.5L Silicone Breathing Bag, 1L Latex-Free Breathing Bag 0.5L PEEP valve Humidification Chamber Disposable Clip, Nose EMST75 Lite Respiratory Trainer Aircushion mask Aircushion mask with hook ring SURE SEAL ANESTHETIC MASK Airlift Resuscitator 1ST RESPONSE INFANT MANUAL RESUSCITATOR 1ST RESPONSE PEDIATRIC MANUAL RESUSCITATOR Ventilator, emergency, manual(resus Nasal oxygen cannula Oxi.Plus Nasal Cannula Set, #0 Oxygen Conserving Cannula Softip-3 Nasal Cannula, Child C22 Star Lumen Tubing, 1000cm ADULT SOFT NASAL CANNULA WITH TUBING NHF Prong Kit, #3 ADULT NASAL CANNULA W/O TUBING Flow Indicator w/tubing, 160cm Oxi.Plus Nasal Cannula Set, #3 C22 Star Lumen Tubing, 200cm, 6M NHF Prong Kit, #4 Auto Chamber, Infant NEONATE SOFT NASAL CANNULA WITH TUBING Softip-1 Nasal Cannula, Infant Softip-3 Nasal Cannula, Adult Softip-3 Nasal Cannula, Infant Oxi.Plus Nasal Cannula Set, #2 ADULT NASAL CANNULA WITH TUBING Softip-1 Nasal Cannula, Adult Oxi.Plus Nasal Cannula Set, #1 PAEDIATRIC SOFT NASAL CANNULA WITH TUBING NHF Prong Kit, #2 Softip-1 Nasal Cannula, Child C23 Star Lumen Tubing, 200cm, 6M Flare Nasal Cannula, Adult Flow Indicator w/tubing, 200cm Swivel Anesthesia Circuit, Adult Manifold, 3 Way, PSF Hytrel Ckt, Child, 120cm w/Water Trap CV-3 Manifold, L22M Disposable respiratory circuit Disposable anesthesia circuit Single limb manifold EVA Circuit, Adult, 180cm EVA Single Limb Circuit, 165cm EVA Circuit, Adult, 180cm w/Mask #4 Disposable Anesthesia Circuit, Coaxial Circuit, Adult, 180cm EVA Single Limb Circuit, 165cm w/WT VENTILATOR CIRCUIT Anesthesia set Basic, latexfree VentStar Anaesthesia w/o LuerL Reusable Breathing Circuit, Single Limb Anesth. Set Basic Latexfr.,US Manifold, 2 way, PSF VentStar Basic P 150 w/o LuerL Vent Set Basic Silicone J-Circuit, Adult Silicone Single Limb Circuit, Adult Standard Coaxial Circuit (150cm tubing), Adult Hytrel Ckt, Adult, 120cm w/2 Water Trap EVA Circuit, Adult, 1.5m Theta Circuit, 150cm Anesthesia Circuit, Adult, 1.5m Theta Anesthesia Circuit, 180 cm, Adult HBC Adult Breathing Circuit Sil.Plus Circuit, Adult w/2 Water Trap Coaxial Circuit, Adult, 1.8m Anesthesia Circuit, Adult, 1.8m Standard Coaxial Circuit (180cm tubing), Adult Durable Silicone Breathing Circuit with water trap, Adult VentStar Anesth (P) w/o. LuerL Theta Circuit, 180cm Disposable anesthesia circuit 1.5m (Adult, latex-free breathing bag 3L) ECO Anesthesia Circuit, Adult Sil.Plus Circuit, Child w/2 Water Trap Coaxial Circuit, Adult, 1.5m L Connector, 22F, 22/15mm, PC Disposable Tail Valve 12M, 15M Disposable Respiratiory Circuit, Single Limb Vent Set Flex Anesthesia Circuit, Adult, 1.2m Anesthesia set Flex, latexfree Disposable anesthesia circuit 1.5m (Child, latex-free breathing bag 1L) Hytrel Circuit, Adult w/Water Trap Hytrel Ckt, Child, 120cm w/2 Water Trap Utopia AV Full face mask Silicone breathing hose, adult, 1.5m Hydrophobic filter for pressure tubing line Gas Sampling Line, Adult 2.5 m Silicone breathing hose, adult, 0.45m Silicone breathing hose Disposable corrugate tube Reusable swivel flex tube Aerosol Tube Assembly Carrier Gas Tube Assembly Oxygen Line Accessory Gas Sampling Line, 50cm, 4M, 4M Pressure line for Ckt, 180cm, L6F, 4.3M Filter, Hydrophobic 4F, 4M Gas Sampling Set (Sidestream) Gas Sampling Line, 300cm, 4M GALEMED TUBING Hytrel Hose, 22F/19T, 110cm, Blue Hytrel Hose, 22F/19T, 60cm, Blue Hytrel Hose, 15F/15T, 60cm, Blue Sil.Flex Hose, 22F, 35cm Silicone Hose, 22F, 20cm Silicone breathing hose, child/infant, 1.5m EVA corraguate tube, 1.8m, bue Gas Sampling Line, Neonate 2.5 m EVA SB Hose, 22F, 180cm Nihon Kohden Exhalation Port Aircushion mask,size 4,adult Aircushion mask, size 2, Child NASAL CPAP MASK Aircushion mask, Size 5, Adult Large Economy reusable mask, #5, adult large Silicone mask, size 2, child Aircushion mask, size 1, infant large Venturi, 31% O2, 22M, White Venturi, 50% O2, 22M, Orange OM-1 Mask, Infant w/Tubing OM-2 HiO2 Mask, Child AM-3 Adj-Venturi Mask, Child w/Tube Venturi, 40% O2/8LPM, 22M, Red Adj Venturi (LAV) Adaptor, 22F Venturi, 35% O2, 22M, Green LAV Venturi Mask Kit, Adult M1 HiO2 Mask, L AM-2 HiO2 Mask, Adult TM-1 Trachea Mask, Adult w/Tubing Venturi, 50% O2, 22F, Orange OM-2 Hi-O2 Mask, Adult AM-2 Oxygen Mask, Adult OM-3 HiO2 Mask, Child w/Tubing, PVC Bag OM-1 HiO2 Mask, Infant w/Tubing M1 Oxygen Mask, M OM-5 face Tent w/Tubing AM-3 Venturi Mask, Adult Venturi, 24% O2, 22M, Blue OM-1 Mask, Adult OM-2 PR-Mask, Adult w/Tubing Venturi, 28% O2, 22M, Yellow GALEMED MASK AM-2 Aerosol Mask, Adult Silicone mask, size 0, infant AM-2 Aerosol Mask, Child Economy reusable mask, #3, child large Aircushion mask, size 0, infant Silicone mask, size 1, infant large Economy reusable mask, #4, adult CPAP Face Mask Set w/Hose, S NIV Mask, S EVA SB Hose, 19f, 180cm w/Cuff, 22F*2 NIV Mask CPAP Full Mask CPAP/VPAP Mask CPAP Face Mask Set w/Hose, M CPAP Face Mask Set w/Hose, L NIV Mask, L NIV Mask, M VentStar Oxylog 3000F (P) 190 Venti.Plus Disposable Pressure Manometer Disposable Pressure Manometer Dual Limb Circuit for Pneupac Ventilators Single Limb Circuit for Pneupac Ventilators Dual Limb Circuit for Pneupac® babyPACTM Ventilators Single Limb Circuit for Pneupac® DEMAND type Ventilators, with PEEP Valve and Pressure Monitoring Line with In-Line Filt Single Limb Circuit for Pneupac® paraPAC plusTM Ventilator with 0-20 cmH2O PEEP Valve and Internal Pressure Monitoring Single Limb Circuit for Pneupac® DEMAND type Ventilators, with PEEP Valve Single Limb Circuit for Pneupac® paraPAC plusTM Ventilators with Internal Pressure Monitoring Line with In-Line Filter Single Limb Circuit for Pneupac® DEMAND type Ventilators Mouth Piece, 13M Connector, 15M, 5F, PP Connector, 22M, 22/15mm, PP Reusable wye connector Reusable elbow connector Reusable straight connector Disposable swivel wye connector In-Line NebTee with Valve Disposable elbow connector Disposable straight connector Disposable wye connector SY Connector , 15F, 15B, 7.6F Connector, 22F, 10/7.6mm, PSF S connector, 22/15mm, 15M, 4.3F DS-L Connector w/Suction Port, 15F, 15M, Y Connector, 15F, 10M, 7.6F, 6M L Connector, 22F, 22/15mm PSF Cap w/strap 7.6F, 6F Connector, 22/15mm, 22/15mm SP Connector, 22F, 22/15mm, 7.6F Y Connector, 15F, 10M, 7.6F L Connector, 22M, 22/15mm, PSF Flow Meter Adaptor, Green MDI Adaptor, 15F, 15M T Connector, 7.6F, 7.6/4.3mm, 7.6M CPAP Exhale Vent, 22M, 22M L Connector , 22/15mm, 15M, 7.6F DS-L Connector, 15F, 15M w/Seal Cap Flow Meter Adaptor, 22M/15F, Aluminum Connector, 22M, 22/19mm, PP Connector, 22F, 22F, PC SY Connector, 22B, L4B Swivel Connector w/Clamp Cap, 15F, Yellow Connector, 22F, 15M, K Resin L Connector, 7.6M, 4B, PSF, Amber T Connector, 15F, 22/18mm, 15M SP Connector, 22F, 22/15mm, 6M SP Connector, 22F, 22/15mm, Luer, PC Connector, 22F, 22F, PSF T Connector,10/7.6mm,10/7.6mm,10/7.6mm L Connector , 22/15mm, 15M, 6M Flow Meter Adaptor, White SP Connector, 22F, 22/15mm, 7.6F, PSF Y Connector, 22/15mm, 22M, 7.6F In-Line Valve Connector, 22F, 22M Connector, 15M, 10F Y Connector, 15F, 10M, PSF Connector, 15F, 15M, PP L Connector, 22/15mm, 15M, Luer T Connector , 22M, 22/15mm, 22M, 7.6F T Connector, 22M, 22/18mm, 22M Y Connector w/Luer, 15F, 10M Connector, 30F, 22M, PP DS-L Connector, 22/15mm, 15M Y Connector w/port , 22/15mm, 22M T Adaptor for Jackson Rees Circuit Y Connector, 15F, 15Mx2, 4.3F, PC Connector, 22/15mm, 15M, 7.6F Connector, 10F/10F, Silicone L Connector, 15F, 15M, PSF, Amber L connector, 22/15mm, 15M, 7.6F SP Connector, 22F, 22/15mm, 6M, PC Y Connector, 15F, 15M, 7.6F Cap w/Strap 4.3M, Green Bear Pacifier Adaptor Y Connector, 22F w/7.6F SP Connector, 22/15mm, 10F, 6M Connector, 7.6M, Luer, PSF Connector, 22F, 15M, PC Valve Tee, 22F, 18F, 22/15mm Y Connector, 15F, 22M Connector, 22F, 22F, K Resin Y Connector, 22/15mm, 22M Adaptor for O2 Mask, 18M, 6M Y Connector, 22/15mm, 22M, 4.3F T connector w/luer, 22M, 22/15mm, 22M Catheter Mount, 20cm, 22/15mm, 15M Connector, 22/15mm, 6M, PP VENTI.PLUS SINGLE POLE CLAMP SP connector, 22/15mm, 15M, 6M(X) Neonate Connector Kit Y Connector, 15F, 10M Connector, 22F, 22/15mm, PC Connector, 10F, 10/7.6mm, K Resin Connector, 6M, 4M, K Resin CV-5 manifold 22F/19M,22F/15M,7.5M,4.3M T Connector, 22M, 22/15mm, 22M Y connector, 15F, 10Mx2, 6M AIRWAY CONNECTOR C2 Tubing Adaptor, 6F, PVC MDI L-Adaptor, 22M/15F, 15M Adaptor for HiO2 Mask w/Valve DS-L Connector w/Suction Port, 15M Rescu-7 Diverter, 30/26mm Connector, 5M, 5M, K Resin Connector, 15F, 5.5F, PP SP Connector, 22/15mm, 22/15mm, 6M Cap, 22F, Green Cap w/Strap, 4M, Silicone Venti.Plus Dual Pole Clamp T Connector w/Luer, 22F, 10/7.6mm Cap w/Strap, for 7.6F Taper Port Connector, 10/7.6mm, 10f, PSF Y connector, 22Mx2, 22/15 (X) T Connector , 22F, 22/18mm, 22M, 6M Connector, 22/15mm, 15M, PSF Connector, 22F, 22/15mm, PSF ADU Connector Valve Tee, 15F, 18F, 15M T Connector w/Luer, 22M, 22/15mm, 22M Valve Tee, 22M, 18F 22M SP Connector, 22/15mm, 15M, 6M Connector, 22/15mm, 22/15mm PSF L Connector, 4.3M, 4M In-Line Valve Connector, 22M, 22F Connector, 22F, 15F, PP T Connector, 22F, 22/18mm, 22M, PS SP Connector, 22/15mm, 15M, 7.6F SP Connector, 22F, 22M, 8.5M Connector, 15M, 4.5F, PP SP Connector, 22F, 10/7.6mm, Luer Connector, 32M, 22M, PP T Connector, 22F, 22/18mm, 22M MR-100 Diverter, 30/26mm L Connector, 22M w/Luer Port Neonate Straight connector, 7.6/10mm L Connector, 7.6M, 6M, PSF, Amber T Connector, 10F, 4.3F, 10/7.6mm SY Connector, 15F, 10M, 7.6F Connector, 15M, 6M, PP Reusable wye connector, 22M Straight Connector 22/15mm, 15M, Luer Reusable elbow connector, 22M/15F, 22F Valves Aerosol Tee Adaptor HME Disposable Adjustable PEEP Valve MR Conditional PEEP Valve, 5-20cmH2O, 30F w/adapter BERMAN AIRWAY Guedel Airway 8cm, Green COLOR CODED AIRWAYS BERMAN 7CM DRAWING REV1 Guedel Airway 9cm, Yellow Berman Airway 9cm BERMAN 5CM BERMAN 8CM DRAWING REV.A BERMAN 6CM DRAWING REV1 EMST150 expiratory muscle device Bravo Trainer, Blue FLOWREST Universal connector C22 Tubing, 200cm, 6/4mm Fits-all Oxygen Tubing Connector Swivel Oxygen Tubing Connector, Male/Female Swivel Oxygen Tubing Connector, Male/Male Disposable Oxygen Tubing R2 Star Lumen Tubing, 200cm, 6M 4.3mm Luer Cap Thread Type Color: Blue VentStar Oxylog 1000 180 Silicone mask Reusable mask Economy reusable mask Aircushion Mask Size 5 SURE SEAL® Air Cushion Mask, w/ Valve, Ped/Toddler SURE SEAL® Air Cushion Mask, w/ Valve, Infant Air-SoftTM Mask Size 1, Infant Large, w/Valve Airsoft Mask, #5 w/Valve SURE SEAL® Air Cushion Mask, Neonate Air-SoftTM Mask Size 3, Child Large, w/Valve AirLifeTM AirLife Disposable Face Mask Neonate Airsoft Mask, #1 Air-SoftTM Mask Size 5, Adult Large, w/Valve SURE SEAL® Air Cushion Mask, w/ Valve, Neonate Endo Mask, L w/Harness Hook ring for LiteStar masks with 15mm connector Air-SoftTM Mask Size 4, Adult, w/Valve Mask LiteStar4 w/o hook SURE SEAL® Air Cushion Mask, Infant RESUSCITATION MASK LARGE ADULT Mask LiteStar1 w/o hook Headgear disp.,soft rub.,large SURE SEAL® Air Cushion Mask, Ped/Toddler SURE SEAL® Air Cushion Mask, Med Adult SURE SEAL® Air Cushion Mask, w/ Valve, Sm Adult/Youth Airsoft Mask, #3 w/Valve Airsoft Mask, #5 RESUSCITATION MASK LARGE CHILD SURE SEAL® Air Cushion Mask, w/ Valve, Large Adult Airsoft Mask, #4 w/Valve RESUSCITATION MASK LARGE INFANT Airsoft Mask, #2 w/Valve Mask LiteStar3 w/o hook Rendell Baker Silicone Mask, #0 SURE SEAL® Air Cushion Mask, Large Adult Airsoft Mask, #4 Headgear disp.,soft fabric,la. Headgear disp.,soft farbic,sm. Airsoft Mask, #2 Headgear disp.,soft rub.,small Airsoft Mask, #1 w/Valve SURE SEAL® Air Cushion Mask, w/ Valve, Med Adult Aircushion Mask Size 3 AIR SOFT MASK, SIZE 1 Airsoft Mask, #3 Ambu® Open Cuff Silicone Face Mask Reusable Face Mask #4 Ambu® Open Cuff Silicone Face Mask Reusable Face Mask #1 Airsoft Mask, #6 w/Valve Mask LiteStar2 w/o hook Airsoft Mask, #0 w/Valve AirLifeTM AirLife Disposable Face Mask Pediatric SURE SEAL® Air Cushion Mask, Sm Adult/Youth Air-SoftTM Mask Size 2, Child, w/Valve Ambu® Open Cuff Silicone Face Mask Reusable Face Mask #3 Airsoft Mask, #0 Mask LiteStar6 w/o hook RESUSCITATION MASK SMALL ADULT Ambu® Open Cuff Silicone Face Mask Reusable Face Mask #2 Ambu Open Cuff Silicone Face Mask Ambu® Open Cuff Silicone Face Mask Reusable Face Mask #0 Mask LiteStar5 w/o hook Ambu® Open Cuff Silicone Face Mask Reusable Face Mask #5 1" Response Manual Resuscitator, Adult 1" Response Pediatric Manual Resuscitator, Child large PocketPak Mouth-to-Mask Resuscitator HUDSON RCI LIFESAVER SINGLE PATIENT USE MANUAL RESUSCITATOR Hybrid AV Interface Disp. humi.chamber f.F&P MR850 LIFESAVER SINGLE PATIENT USE MANUAL RESUSCITATOR AF VIRAL/BACTERIAL FILTER Hydrophobic Filter, 7.6M w/Luer Filter, 30F, 22/15mm Filter, HEPA w/luer, 22F/15M, 22/15mm Filter 22F/15M w/Luer Filter, 30F, 30M Filter, 22F/15M, 22/15mm Venti.PIus Hyperinflation Bag System with Pressure Manometer Manual Resuscitator Durable R7 Resuscitator, Adult w/Mask, Reservoir Hybrid NE Interface Utopia NE Full face mask Silicone headband Headgear for mask, L, Rubber Headgear for CPAP Mask, L, Silicone Headgear for CPAP, L, Black

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer) Manufacture Medical Device Export Device to the United States But Perform No Other Operation on Device