Galemed Xiamen Co L T D

FDA Filings

This page includes the latest FDA filings for Galemed Xiamen Co L T D. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)
Registration Number3006783791
FEI Number3006783791
NameGALEMED XIAMEN CO., LTD.
Owner & OperatorGaleMed Corporation
Contact Address87, LI-GONG 2ND RD.,
Wu-jia TW-ILA Ilan 268 TW
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration AddressAmoy Export Processing Zone , 39, Section 3 Haijing East Road,
XIAMEN Fujian, 361026 CN
Establishment Type
  • Manufacture Medical Device
  • Manufacture Medical Device for Another Party (Contract Manufacturer)



FDA Filings

Device
Company
DeviceDate
GaleMed Xiamen Co., Ltd.
N/A AT15-DS2024-10-30
GaleMed Xiamen Co., Ltd.
N/A 2024-09-19
GaleMed Xiamen Co., Ltd.
Mindray 040-007123-002024-07-29
GaleMed Xiamen Co., Ltd.
Mindray 040-006322-002024-07-29
GaleMed Xiamen Co., Ltd.
Mindray 040-006315-002024-07-29
GaleMed Xiamen Co., Ltd.
N/A 2024-06-04
GaleMed Xiamen Co., Ltd.
N/A 2024-06-04
GaleMed Xiamen Co., Ltd.
N/A AB02992023-12-20
GaleMed Xiamen Co., Ltd.
N/A AW00072023-08-24
GaleMed Xiamen Co., Ltd.
N/A AW00062023-08-24
GaleMed Xiamen Co., Ltd.
N/A AW00052023-08-24
GaleMed Xiamen Co., Ltd.
Venti.Plus H100-HD12019-11-27
GaleMed Xiamen Co., Ltd.
Venti.Plus H100-HD2019-11-27
GaleMed Xiamen Co., Ltd.
Venti.Plus H050-HD12019-11-27
GaleMed Xiamen Co., Ltd.
Venti.Plus H050-HD2019-11-27
GaleMed Xiamen Co., Ltd.
GaleMed 2019-01-23
GaleMed Xiamen Co., Ltd.
GaleMed 2019-01-23
GaleMed Xiamen Co., Ltd.
GaleMed 2019-01-23
GaleMed Xiamen Co., Ltd.
GaleMed 2018-07-06
GaleMed Xiamen Co., Ltd.
GaleMed 2018-07-06
GaleMed Xiamen Co., Ltd.
GaleMed 2018-07-06
GaleMed Xiamen Co., Ltd.
GaleMed 4524-HD2018-07-06
GaleMed Xiamen Co., Ltd.
LIFESAVER HD-54742018-07-06
GaleMed Xiamen Co., Ltd.
LIFESAVER HD-54732018-07-06
GaleMed Xiamen Co., Ltd.
LIFESAVER HD-54722018-07-06
GaleMed Xiamen Co., Ltd.
LIFESAVER HD-54712018-07-06
GaleMed Xiamen Co., Ltd.
LIFESAVER HD-54702018-07-06
GaleMed Xiamen Co., Ltd.
LIFESAVER HD-5468 2018-07-06
GaleMed Xiamen Co., Ltd.
LIFESAVER HD-5467 2018-07-06
GaleMed Xiamen Co., Ltd.
LIFESAVER HD-54662018-07-06
GaleMed Xiamen Co., Ltd.
LIFESAVER HD-54632018-07-06
GaleMed Xiamen Co., Ltd.
LIFESAVER HD-54622018-07-06
GaleMed Xiamen Co., Ltd.
LIFESAVER HD-54612018-07-06
GaleMed Xiamen Co., Ltd.
GaleMed 2018-07-06
GaleMed Xiamen Co., Ltd.
LIVESAVER 53402018-07-06
GaleMed Xiamen Co., Ltd.
LIFESAVER 53472018-07-06
GaleMed Xiamen Co., Ltd.
LIFESAVER 53462018-07-06
GaleMed Xiamen Co., Ltd.
LIFESAVER 53452018-07-06
GaleMed Xiamen Co., Ltd.
LIFESAVER 53422018-07-06
GaleMed Xiamen Co., Ltd.
LIFESAVER 53412018-07-06
GaleMed Xiamen Co., Ltd.
GaleMed 2018-03-29
GaleMed Xiamen Co., Ltd.
GaleMed 2018-03-29
GaleMed Xiamen Co., Ltd.
GaleMed 2018-03-29
GaleMed Xiamen Co., Ltd.
GaleMed 2018-03-29
GaleMed Xiamen Co., Ltd.
Sil-Flex 2018-03-29
GaleMed Xiamen Co., Ltd.
GaleMed 2018-03-29
GaleMed Xiamen Co., Ltd.
GaleMed 2018-03-29
GaleMed Xiamen Co., Ltd.
GaleMed 2018-03-29
GaleMed Xiamen Co., Ltd.
Sil-Flex 2018-03-29
GALEMED XIAMEN CO., LTD. [GaleMed Corporation]
Swivel Oxygen Tubing Connector2016-02-25
GALEMED XIAMEN CO., LTD. [GaleMed Corporation]
Swivel Oxygen Tubing Connector with Clip2016-02-25
GALEMED XIAMEN CO., LTD. [GaleMed Corporation]
Disposable Tail-End Valve2015-05-21
GALEMED XIAMEN CO., LTD. [GaleMed Corporation]
Single Limb Circuit for Pneupac Ventilators2015-01-26
GALEMED XIAMEN CO., LTD. [GaleMed Corporation]
Dual Limb Circuit for Pneupac Ventilators2015-01-26
GALEMED XIAMEN CO., LTD. [GaleMed Corporation]
Single Limb Circuit for Pneupac Ventilators2015-01-26
GALEMED XIAMEN CO., LTD. [GaleMed Corporation]
Dual Limb Circuit for Pneupac Ventilators2015-01-26
GALEMED XIAMEN CO., LTD. [GaleMed Corporation]
BF VIRAL/BACTERIAL FILTER2014-05-26
GALEMED XIAMEN CO., LTD. [GaleMed Corporation]
AF VIRAL/BACTERIAL FILTER2014-05-26
GALEMED XIAMEN CO., LTD. [GaleMed Corporation]
Disposable Adjustable PEEP Valve MR Conditional2014-04-28
GALEMED XIAMEN CO., LTD. [GaleMed Corporation]
Silicone headband2014-01-17
GALEMED XIAMEN CO., LTD. [GaleMed Corporation]
PocketPak Mouth-to-Mask Resuscitator2013-12-10
GALEMED XIAMEN CO., LTD. [GaleMed Corporation]
Venti.PIus Hyperinflation Bag System with Pressure Manometer2013-12-10
GALEMED XIAMEN CO., LTD. [GaleMed Corporation]
Hybrid AV Interface2013-12-10
GALEMED XIAMEN CO., LTD. [GaleMed Corporation]
Utopia NE Full face mask2013-12-10
GALEMED XIAMEN CO., LTD. [GaleMed Corporation]
Hybrid NE Interface2013-12-10
GALEMED XIAMEN CO., LTD. [GaleMed Corporation]
Utopia AV Full face mask2013-12-10
GALEMED XIAMEN CO., LTD. [GaleMed Corporation]
Hybrid Complete System2013-12-10
GALEMED XIAMEN CO., LTD. [GaleMed Corporation]
Sylent2013-12-10
GALEMED XIAMEN CO., LTD. [GaleMed Corporation]
Sylent NE2013-12-10
GALEMED XIAMEN CO., LTD. [GaleMed Corporation]
Bravo2013-12-10
GALEMED XIAMEN CO., LTD. [GaleMed Corporation]
Bravo II2013-12-10
GALEMED XIAMEN CO., LTD. [GaleMed Corporation]
Humidification Chamber Disposable2013-12-10
GALEMED XIAMEN CO., LTD. [GaleMed Corporation]
Airlift Resuscitator2013-10-31
GALEMED XIAMEN CO., LTD. [GaleMed Corporation]
water trap2013-07-31
GALEMED XIAMEN CO., LTD. [GaleMed Corporation]
Reusable water trap2013-07-31
GALEMED XIAMEN CO., LTD. [GaleMed Corporation]
breathing bag2013-07-31
GALEMED XIAMEN CO., LTD. [GaleMed Corporation]
Silicone Breathing Bag2013-07-31
GALEMED XIAMEN CO., LTD. [GaleMed Corporation]
Latex-Free Breathing2013-07-31
GALEMED XIAMEN CO., LTD. [GaleMed Corporation]
Latex Breathing Bag2013-07-31
GALEMED XIAMEN CO., LTD. [GaleMed Corporation]
FLOWREST2013-07-24
GALEMED XIAMEN CO., LTD. [GaleMed Corporation]
HUDSON RCI LIFESAVER SINGLE PATIENT USE MANUAL RESUSCITATOR2012-12-17
GALEMED XIAMEN CO., LTD. [GaleMed Corporation]
EXHALOMETER2012-12-17
GALEMED XIAMEN CO., LTD. [GaleMed Corporation]
EXHALOMETER2012-12-17
GALEMED XIAMEN CO., LTD. [GaleMed Corporation]
LIFESAVER SINGLE PATIENT USE MANUAL RESUSCITATOR2012-03-30
GALEMED XIAMEN CO., LTD. [GaleMed Corporation]
HME2012-01-10
GALEMED XIAMEN CO., LTD. [GaleMed Corporation]
PEEP valve2011-09-22
GALEMED XIAMEN CO., LTD. [GaleMed Corporation]
Manual Resuscitator Durable2011-05-13
GALEMED XIAMEN CO., LTD. [GaleMed Corporation]
Clip, Nose2011-02-09
GALEMED XIAMEN CO., LTD. [GaleMed Corporation]
Venti.Plus Disposable Pressure Manometer2010-12-06
GALEMED XIAMEN CO., LTD. [GaleMed Corporation]
Disposable Pressure Manometer2010-12-06
GALEMED XIAMEN CO., LTD. [GaleMed Corporation]
Disposable PEEP Valve2008-11-05
GALEMED XIAMEN CO., LTD. [GaleMed Corporation]
Dispo-Bag Manual Resuscitator2008-11-05
GALEMED XIAMEN CO., LTD. [GaleMed Corporation]
Dispo-BAG Manual Resuscitation Bag2008-11-05
GALEMED XIAMEN CO., LTD. [GaleMed Corporation]
DISPO-BAG Manual Resuscitation Bag with Disposable PEEP Valve2008-11-05
GALEMED XIAMEN CO., LTD. [GaleMed Corporation]
Disposable PEEP Valve2008-11-05
GALEMED XIAMEN CO., LTD. [GaleMed Corporation]
Dispo-Bag Manual Resuscitator2008-11-05
GALEMED XIAMEN CO., LTD. [GaleMed Corporation]
Dispo-BAG Manual Resuscitation Bag2008-11-05
GALEMED XIAMEN CO., LTD. [GaleMed Corporation]
DISPO-BAG Manual Resuscitation Bag with Disposable PEEP Valve2008-11-05
GALEMED XIAMEN CO., LTD. [GaleMed Corporation]
Ventilator, emergency, manual(resus2008-03-03
GALEMED XIAMEN CO., LTD. [GaleMed Corporation]
1ST RESPONSE PEDIATRIC MANUAL RESUSCITATOR2008-03-03
GALEMED XIAMEN CO., LTD. [GaleMed Corporation]
1ST RESPONSE INFANT MANUAL RESUSCITATOR2008-03-03
GALEMED XIAMEN CO., LTD. [GaleMed Corporation]
Ventilator, emergency, manual(resus2008-03-03
GALEMED XIAMEN CO., LTD. [GaleMed Corporation]
1" Response Pediatric Manual Resuscitator, Child large2008-03-03
GALEMED XIAMEN CO., LTD. [GaleMed Corporation]
Ventilator, emergency, manual(resus2008-03-03
GALEMED XIAMEN CO., LTD. [GaleMed Corporation]
1" Response Manual Resuscitator, Adult2008-03-03
GALEMED XIAMEN CO., LTD. [GaleMed Corporation]
NIV Mask2007-12-19
GALEMED XIAMEN CO., LTD. [GaleMed Corporation]
CPAP/VPAP Mask2007-12-19
GALEMED XIAMEN CO., LTD. [GaleMed Corporation]
CPAP Full Mask2007-12-19
GALEMED XIAMEN CO., LTD. [GaleMed Corporation]
SURE SEAL ANESTHETIC MASK2007-03-14
GALEMED XIAMEN CO., LTD. [GaleMed Corporation]
Aircushion mask2007-03-14
GALEMED XIAMEN CO., LTD. [GaleMed Corporation]
Aircushion mask with hook ring2007-03-14
GALEMED XIAMEN CO., LTD. [GaleMed Corporation]
Neb-Easy Nebulizer2007-03-14
GALEMED XIAMEN CO., LTD. [GaleMed Corporation]
GaleMed Large Volume Nebulizer2007-03-14
GALEMED XIAMEN CO., LTD. [GaleMed Corporation]
GALEMED NEBULIZER SET2007-03-14
GALEMED XIAMEN CO., LTD. [GaleMed Corporation]
GALEMED LARGE VOLUME2007-03-14
GALEMED XIAMEN CO., LTD. [GaleMed Corporation]
VENTILATOR CIRCUIT2007-03-14
GALEMED XIAMEN CO., LTD. [GaleMed Corporation]
Single limb manifold2007-03-14
GALEMED XIAMEN CO., LTD. [GaleMed Corporation]
Disposable respiratory circuit2007-03-14
GALEMED XIAMEN CO., LTD. [GaleMed Corporation]
Disposable anesthesia circuit2007-03-14
GALEMED XIAMEN CO., LTD. [GaleMed Corporation]
GUEDEL AIRWAY2007-03-14
GALEMED XIAMEN CO., LTD. [GaleMed Corporation]
COLOR CODED AIRWAYS2007-03-14
GALEMED XIAMEN CO., LTD. [GaleMed Corporation]
BERMAN AIRWAY2007-03-14
GALEMED XIAMEN CO., LTD. [GaleMed Corporation]
Silicone breathing hose2007-03-14
GALEMED XIAMEN CO., LTD. [GaleMed Corporation]
Reusable swivel flex tube2007-03-14
GALEMED XIAMEN CO., LTD. [GaleMed Corporation]
Oxygen Line Accessory2007-03-14
GALEMED XIAMEN CO., LTD. [GaleMed Corporation]
GALEMED TUBING2007-03-14
GALEMED XIAMEN CO., LTD. [GaleMed Corporation]
Disposable corrugate tube2007-03-14
GALEMED XIAMEN CO., LTD. [GaleMed Corporation]
Carrier Gas Tube Assembly2007-03-14
GALEMED XIAMEN CO., LTD. [GaleMed Corporation]
Aerosol Tube Assembly2007-03-14
GALEMED XIAMEN CO., LTD. [GaleMed Corporation]
Reusable wye connector2007-03-14
GALEMED XIAMEN CO., LTD. [GaleMed Corporation]
Reusable straight connector2007-03-14
GALEMED XIAMEN CO., LTD. [GaleMed Corporation]
Reusable elbow connector2007-03-14
GALEMED XIAMEN CO., LTD. [GaleMed Corporation]
In-Line NebTee with Valve2007-03-14
GALEMED XIAMEN CO., LTD. [GaleMed Corporation]
Disposable wye connector2007-03-14
GALEMED XIAMEN CO., LTD. [GaleMed Corporation]
Disposable swivel wye connector2007-03-14
GALEMED XIAMEN CO., LTD. [GaleMed Corporation]
Disposable straight connector2007-03-14
GALEMED XIAMEN CO., LTD. [GaleMed Corporation]
Disposable elbow connector2007-03-14
GALEMED XIAMEN CO., LTD. [GaleMed Corporation]
AIRWAY CONNECTOR2007-03-14
GALEMED XIAMEN CO., LTD. [GaleMed Corporation]
NASAL CPAP MASK2007-03-14
GALEMED XIAMEN CO., LTD. [GaleMed Corporation]
GALEMED MASK2007-03-14
GALEMED XIAMEN CO., LTD. [GaleMed Corporation]
Silicone mask2004-09-15
GALEMED XIAMEN CO., LTD. [GaleMed Corporation]
SURE SEAL ANESTHETIC MASK2004-09-15
GALEMED XIAMEN CO., LTD. [GaleMed Corporation]
Reusable mask2004-09-15
GALEMED XIAMEN CO., LTD. [GaleMed Corporation]
Economy reusable mask2004-09-15
GALEMED XIAMEN CO., LTD. [GaleMed Corporation]
Ambu Open Cuff Silicone Face Mask2004-09-15

Related Finance Registrations
U.S. Import Records [external site]
Import IDShipmentCargo DescriptionQuantity
2020092628949Xiamen,China (Mainland) -> New York/Newark Area, Newark, New JerseyMEDICAL EQUIPMENT100 CTN
202008315332Xiamen,China (Mainland) -> New York/Newark Area, Newark, New JerseyMEDICAL EQUIPMENT25 CTN
2020073119013Xiamen,China (Mainland) -> New York/Newark Area, Newark, New JerseyMEDICAL EQUIPMENT25 CTN
2020073017388Xiamen,China (Mainland) -> New York/Newark Area, Newark, New JerseyMEDICAL EQUIPMENT25 CTN
2020071730298Xiamen,China (Mainland) -> Long Beach, CaliforniaFILTER90 CTN
2020071445412Xiamen,China (Mainland) -> Long Beach, CaliforniaFILTER90 CTN
2020070823928Xiamen,China (Mainland) -> New York/Newark Area, Newark, New JerseyMEDICAL EQUIPMENT250 CTN
2020062414448Xiamen,China (Mainland) -> New York/Newark Area, Newark, New JerseyMEDICAL EQUIPMENT40 CTN

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