Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

8043316

FEI Number

3003319165

Entity Name

GALEMED CORP.

City/State/Country

WU-JIA Yilan, TW

Establishment Address

No.87, LI-GONG 2ND RD.,, WU-JIA Yilan 268, TW

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

GaleMed Corporation (Owner Number: 8043316)

Owner / Operator Contact Address

87, LI-GONG 2ND RD.,, Wu-jia, TW-ILA 268, TW

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K092687

PMA Number

N/A

All Registered Proprietary Names

EMST150 expiratory muscle device Bravo Trainer, Blue BABI PLUS INFANT NASAL CANNULA SYSTEM 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 L Connector, 22F, 22/15mm, PC 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 GALEMED PEAK FLOW METER nProng, #6 nProng, #7 nProng, #3 BABI PLUS INFANT NASAL CANNULA SYSTEM nCPAP Nasal Kit nProng, #1 nProng, #2 nProng, #4 nProng, #0 nProng, #5 1ST RESPONSE INFANT MANUAL RESUSCITATOR 1ST RESPONSE PEDIATRIC MANUAL RESUSCITATOR Ventilator, emergency, manual(resus Hook rings for face masks, disposable Circuit Hanger and Mounting System 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 Universal connector C22 Tubing, 200cm, 6/4mm Fits-all Oxygen Tubing Connector Swivel Oxygen Tubing Connector, Male/Female C22 Star Lumen Tubing, 200cm, 6M Swivel Oxygen Tubing Connector, Male/Male Disposable Oxygen Tubing R2 Star Lumen Tubing, 200cm, 6M 4.3mm Luer Cap Thread Type Color: Blue 1" Response Pediatric Manual Resuscitator, Child large Ventilator, emergency, manual(resus 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 Pneupac babyPAC HME 1" Response Manual Resuscitator, Adult Ventilator, emergency, manual(resus 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 water trap Reusable water trap Water trap set EXHALOMETER 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 Clip, Nose Manual Resuscitator Durable R7 Resuscitator, Adult w/Mask, Reservoir Rescu-7 Diverter, 30/26mm CPR SUPER POCKET PACK Oxi.Plus Oxi.Hood FLOWREST NESSI OTC SPACER Airway Elbow Adapter, Disposable Adapter for Gas Return Airway Straight T Adapter, Disposable 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 Gio Digital Pressure Monometer 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 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 BabI PIus N Bag BABI PLUS NEONATAL RESUSCITATION BAG nBag Resuscitator Venti.PIus Hyperinflation Bag System with Pressure Manometer

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
ION	Exerciser, Non-Measuring	Physical Medicine	Class 1	890.5370	2023-05-13
BZD	Ventilator, Non-Continuous (Respirator)	Anesthesiology	Class 2	868.5905	2010-12-22
BZA	Connector, Airway (Extension)	Anesthesiology	Class 1	868.5810	2007-03-14
BZH	Meter, Peak Flow, Spirometry	Anesthesiology	Class 2	868.1860	2007-03-14
BZD	Ventilator, Non-Continuous (Respirator)	Anesthesiology	Class 2	868.5905	2011-11-02
BTM	Ventilator, Emergency, Manual (Resuscitator)	Anesthesiology	Class 2	868.5915	2008-03-03
BSZ	Gas-Machine, Anesthesia	Anesthesiology	Class 2	868.5160	2014-11-21
JAY	Support, Breathing Tube	Anesthesiology	Class 1	868.5280	2011-09-06
BZO	Set, Tubing And Support, Ventilator (W Harness)	Anesthesiology	Class 1	868.5975	2007-03-14
BYX	Tubing, Pressure And Accessories	Anesthesiology	Class 1	868.5860	2016-02-25
BTM	Ventilator, Emergency, Manual (Resuscitator)	Anesthesiology	Class 2	868.5915	2008-03-03
BTL	Ventilator, Emergency, Powered (Resuscitator)	Anesthesiology	Class 2	868.5925	2015-01-26
BYE	Attachment, Breathing, Positive End Expiratory Pressure	Anesthesiology	Class 2	868.5965	2015-01-26
BTL	Ventilator, Emergency, Powered (Resuscitator)	Anesthesiology	Class 2	868.5925	2020-04-07
BYD	Condenser, Heat And Moisture (Artificial Nose)	Anesthesiology	Class 1	868.5375	2012-01-10
BTM	Ventilator, Emergency, Manual (Resuscitator)	Anesthesiology	Class 2	868.5915	2008-03-03
CAF	Nebulizer (Direct Patient Interface)	Anesthesiology	Class 2	868.5630	2007-03-14
BYH	Drain, Tee (Water Trap)	Anesthesiology	Class 1	868.5995	2013-07-31
CAH	Filter, Bacterial, Breathing-Circuit	Anesthesiology	Class 2	868.5260	2012-12-17
BZK	Spirometer, Monitoring (W/Wo Alarm)	Anesthesiology	Class 2	868.1850	2012-12-17
BZD	Ventilator, Non-Continuous (Respirator)	Anesthesiology	Class 2	868.5905	2007-12-19
BXJ	Clip, Nose	Anesthesiology	Class 1	868.6225	2011-02-09
BTM	Ventilator, Emergency, Manual (Resuscitator)	Anesthesiology	Class 2	868.5915	2011-05-13
CBP	Valve, Non-Rebreathing	Anesthesiology	Class 2	868.5870	2007-03-14
BYL	Tent, Oxygen	Anesthesiology	Class 1	868.5700	2011-09-21
BTT	Humidifier, Respiratory Gas, (Direct Patient Interface)	Anesthesiology	Class 2	868.5450	2013-07-24
NVO	Spacer, Direct Patient Interface	Anesthesiology	Class 2	868.5630	2011-07-26
DXJ	Display, Cathode-Ray Tube, Medical	Cardiovascular	Class 2	870.2450	2014-11-21
CAE	Airway, Oropharyngeal, Anesthesiology	Anesthesiology	Class 1	868.5110	2007-03-14
CAP	Monitor, Airway Pressure (Includes Gauge And/Or Alarm)	Anesthesiology	Class 2	868.2600	2013-09-09
CAI	Circuit, Breathing (W Connector, Adaptor, Y Piece)	Anesthesiology	Class 1	868.5240	2007-03-14
BTC	Bag, Reservoir	Anesthesiology	Class 1	868.5320	2013-07-31
BTM	Ventilator, Emergency, Manual (Resuscitator)	Anesthesiology	Class 2	868.5915	2012-02-08
NHK	Resuscitator, Manual, Non Self-Inflating	Anesthesiology	Class 2	868.5905	2013-12-10

Official Correspondent

No official correspondent registered.

US Agent Details

Yong Sun Business: Emergo Global Representation LLC Email: USAgent@ul.com Phone: (512) 3279997

Related Public Records

Same Entity

GaleMed Corporation

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3011659673	GALEMED LIMITED TAIPEI BRANCH	Taipei, TW
3006783791	GaleMed (Xiamen) Co., Ltd.	XIAMEN Fujian, CN

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K792722	Novametrix Medical Systems, Inc.	NOVAMETRIX CPAP NASAL CANNULA	1980-01-24
K082979	Resmed, Ltd.	S8 ADVANCE	2009-01-02
K203126	Resmed Pty , Ltd.	S10 Kirra	2020-12-18
K050853	Card Guard Scientific Survival , Ltd.	PMP4 SPIROPRO	2005-05-04
K123945	Monaghan Medical Corp.	STRIVE DUAL ZONE PEAK FLOW METER	2013-04-17

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0020-2020	Galemed Corporation 87 Wu-Jia Li-Gong 2nd Road I-Lan Taiwan	2	Babi.Plus 12.5 cm H2O Pressure Relief Manifold, REF 1030, RX Only, UDI: 04710810093562
Z-0021-2020	Galemed Corporation 87 Wu-Jia Li-Gong 2nd Road I-Lan Taiwan	2	Babi.Plus Bubble PAP Valve with 12.5 cm H2O Pressure Relief Manifold, REF 1002, Rx Only, UDI: 24710810093559
Z-0022-2020	Galemed Corporation 87 Wu-Jia Li-Gong 2nd Road I-Lan Taiwan	2	Babi.Plus 12.5 cm H2O Pressure Relief Manifold with Gas Supply Tube and Oxygen Sensor Port, REF 2691, Rx Only, UDI: 04710810100802
Z-0009-2020	TELEFLEX-MORRISVILLE	2	Babi.Plus 12.5 cm H2O Pressure Relief Manifold Catalog # 2691 for use with ventilators.
Z-0039-2010	Unomedical	2	Infant Manual Pulmonary Resuscitator with reservoir bag, face mask & Gas sampling elbow. Product ID # 5801, 12-8713, 732-E, and 2206. Packaged under the name of Dynarex, Evergreen, Mada and Hospitak. Recalled codes may be identified by examining the patient valve housing immediately below the right-angle exhalation port, where the retention ring should be visible. MPR units with a clear or transparent ring, as well as those where no ring can be seen, should be returned. MPR units with a blue retention ring are not affected and do not need to be returned.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 8043316. Last updated year: 2026. Please use registration number 8043316 when referencing this establishment in official correspondence.