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 Number: 3006783791
• FEI Number: 3006783791
• Name: GALEMED XIAMEN CO., LTD.
• Owner & Operator: GaleMed Corporation
• Contact Address: 87, LI-GONG 2ND RD., ; Wu-jia TW-ILA Ilan 268 TW
• US Agent:
  • Thomas C. Loescher
  • 858 3533813
  • tom.loescher@galemed.com
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: Amoy 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	Device	Date
GUDID 06923980104435 GaleMed Xiamen Co., Ltd.	N/A AB0299	2023-12-20
GUDID 06923980102028 GaleMed Xiamen Co., Ltd.	N/A AW0007	2023-08-24
GUDID 06923980101939 GaleMed Xiamen Co., Ltd.	N/A AW0006	2023-08-24
GUDID 06923980101922 GaleMed Xiamen Co., Ltd.	N/A AW0005	2023-08-24
GUDID 44710810100299 GaleMed Xiamen Co., Ltd.	Venti.Plus H100-HD1	2019-11-27
GUDID 44710810100282 GaleMed Xiamen Co., Ltd.	Venti.Plus H100-HD	2019-11-27
GUDID 44710810100275 GaleMed Xiamen Co., Ltd.	Venti.Plus H050-HD1	2019-11-27
GUDID 44710810100268 GaleMed Xiamen Co., Ltd.	Venti.Plus H050-HD	2019-11-27
GUDID 44710810114104 GaleMed Xiamen Co., Ltd.	GaleMed	2019-01-23
GUDID 44710810082946 GaleMed Xiamen Co., Ltd.	GaleMed	2019-01-23
GUDID 44710810082656 GaleMed Xiamen Co., Ltd.	GaleMed	2019-01-23
GUDID 44710810101791 GaleMed Xiamen Co., Ltd.	GaleMed	2018-07-06
GUDID 44710810101777 GaleMed Xiamen Co., Ltd.	GaleMed	2018-07-06
GUDID 44710810101753 GaleMed Xiamen Co., Ltd.	GaleMed	2018-07-06
GUDID 44710810100305 GaleMed Xiamen Co., Ltd.	GaleMed 4524-HD	2018-07-06
GUDID 44710810093102 GaleMed Xiamen Co., Ltd.	LIFESAVER HD-5474	2018-07-06
GUDID 44710810093096 GaleMed Xiamen Co., Ltd.	LIFESAVER HD-5473	2018-07-06
GUDID 44710810093089 GaleMed Xiamen Co., Ltd.	LIFESAVER HD-5472	2018-07-06
GUDID 44710810093072 GaleMed Xiamen Co., Ltd.	LIFESAVER HD-5471	2018-07-06
GUDID 44710810093065 GaleMed Xiamen Co., Ltd.	LIFESAVER HD-5470	2018-07-06
GUDID 44710810093058 GaleMed Xiamen Co., Ltd.	LIFESAVER HD-5468	2018-07-06
GUDID 44710810093041 GaleMed Xiamen Co., Ltd.	LIFESAVER HD-5467	2018-07-06
GUDID 44710810093034 GaleMed Xiamen Co., Ltd.	LIFESAVER HD-5466	2018-07-06
GUDID 44710810093027 GaleMed Xiamen Co., Ltd.	LIFESAVER HD-5463	2018-07-06
GUDID 44710810093010 GaleMed Xiamen Co., Ltd.	LIFESAVER HD-5462	2018-07-06
GUDID 44710810093003 GaleMed Xiamen Co., Ltd.	LIFESAVER HD-5461	2018-07-06
GUDID 44710810082915 GaleMed Xiamen Co., Ltd.	GaleMed	2018-07-06
GUDID 24710810093184 GaleMed Xiamen Co., Ltd.	LIVESAVER 5340	2018-07-06
GUDID 04710810093234 GaleMed Xiamen Co., Ltd.	LIFESAVER 5347	2018-07-06
GUDID 04710810093227 GaleMed Xiamen Co., Ltd.	LIFESAVER 5346	2018-07-06
GUDID 04710810093210 GaleMed Xiamen Co., Ltd.	LIFESAVER 5345	2018-07-06
GUDID 04710810093203 GaleMed Xiamen Co., Ltd.	LIFESAVER 5342	2018-07-06
GUDID 04710810093197 GaleMed Xiamen Co., Ltd.	LIFESAVER 5341	2018-07-06
GUDID 44710810085206 GaleMed Xiamen Co., Ltd.	GaleMed	2018-03-29
GUDID 44710810085169 GaleMed Xiamen Co., Ltd.	GaleMed	2018-03-29
GUDID 44710810084315 GaleMed Xiamen Co., Ltd.	GaleMed	2018-03-29
GUDID 44710810083813 GaleMed Xiamen Co., Ltd.	GaleMed	2018-03-29
GUDID 44710810083301 GaleMed Xiamen Co., Ltd.	Sil-Flex	2018-03-29
GUDID 44710810082038 GaleMed Xiamen Co., Ltd.	GaleMed	2018-03-29
GUDID 44710810080690 GaleMed Xiamen Co., Ltd.	GaleMed	2018-03-29
GUDID 04710810084126 GaleMed Xiamen Co., Ltd.	GaleMed	2018-03-29
GUDID 04710810083198 GaleMed Xiamen Co., Ltd.	Sil-Flex	2018-03-29
BYX GALEMED XIAMEN CO., LTD. [GaleMed Corporation]	Swivel Oxygen Tubing Connector	2016-02-25
BYX GALEMED XIAMEN CO., LTD. [GaleMed Corporation]	Swivel Oxygen Tubing Connector with Clip	2016-02-25
CAN GALEMED XIAMEN CO., LTD. [GaleMed Corporation]	Disposable Tail-End Valve	2015-05-21
PMN K123957 | BYE GALEMED XIAMEN CO., LTD. [GaleMed Corporation]	Single Limb Circuit for Pneupac Ventilators	2015-01-26
PMN K123957 | BYE GALEMED XIAMEN CO., LTD. [GaleMed Corporation]	Dual Limb Circuit for Pneupac Ventilators	2015-01-26
PMN K123957 | BTL GALEMED XIAMEN CO., LTD. [GaleMed Corporation]	Single Limb Circuit for Pneupac Ventilators	2015-01-26
PMN K123957 | BTL GALEMED XIAMEN CO., LTD. [GaleMed Corporation]	Dual Limb Circuit for Pneupac Ventilators	2015-01-26
PMN K132679 | CAH GALEMED XIAMEN CO., LTD. [GaleMed Corporation]	BF VIRAL/BACTERIAL FILTER	2014-05-26
PMN K132679 | CAH GALEMED XIAMEN CO., LTD. [GaleMed Corporation]	AF VIRAL/BACTERIAL FILTER	2014-05-26
PMN K133957 | BYE GALEMED XIAMEN CO., LTD. [GaleMed Corporation]	Disposable Adjustable PEEP Valve MR Conditional	2014-04-28
BTK GALEMED XIAMEN CO., LTD. [GaleMed Corporation]	Silicone headband	2014-01-17
PMN K870138 | CBP GALEMED XIAMEN CO., LTD. [GaleMed Corporation]	PocketPak Mouth-to-Mask Resuscitator	2013-12-10
PMN K092687 | NHK GALEMED XIAMEN CO., LTD. [GaleMed Corporation]	Venti.PIus Hyperinflation Bag System with Pressure Manometer	2013-12-10
PMN K062224 | BZD GALEMED XIAMEN CO., LTD. [GaleMed Corporation]	Hybrid AV Interface	2013-12-10
PMN K062019 | CBK GALEMED XIAMEN CO., LTD. [GaleMed Corporation]	Utopia NE Full face mask	2013-12-10
PMN K062019 | CBK GALEMED XIAMEN CO., LTD. [GaleMed Corporation]	Hybrid NE Interface	2013-12-10
PMN K052249 | BZD GALEMED XIAMEN CO., LTD. [GaleMed Corporation]	Utopia AV Full face mask	2013-12-10
PMN K052227 | BZD GALEMED XIAMEN CO., LTD. [GaleMed Corporation]	Hybrid Complete System	2013-12-10
PMN K050171 | BZD GALEMED XIAMEN CO., LTD. [GaleMed Corporation]	Sylent	2013-12-10
PMN K050171 | BZD GALEMED XIAMEN CO., LTD. [GaleMed Corporation]	Sylent NE	2013-12-10
PMN K022465 | BZD GALEMED XIAMEN CO., LTD. [GaleMed Corporation]	Bravo	2013-12-10
PMN K022465 | BZD GALEMED XIAMEN CO., LTD. [GaleMed Corporation]	Bravo II	2013-12-10
PMN K001213 | BTT GALEMED XIAMEN CO., LTD. [GaleMed Corporation]	Humidification Chamber Disposable	2013-12-10
BTM GALEMED XIAMEN CO., LTD. [GaleMed Corporation]	Airlift Resuscitator	2013-10-31
BYH GALEMED XIAMEN CO., LTD. [GaleMed Corporation]	water trap	2013-07-31
BYH GALEMED XIAMEN CO., LTD. [GaleMed Corporation]	Reusable water trap	2013-07-31
BTC GALEMED XIAMEN CO., LTD. [GaleMed Corporation]	breathing bag	2013-07-31
BTC GALEMED XIAMEN CO., LTD. [GaleMed Corporation]	Silicone Breathing Bag	2013-07-31
BTC GALEMED XIAMEN CO., LTD. [GaleMed Corporation]	Latex-Free Breathing	2013-07-31
BTC GALEMED XIAMEN CO., LTD. [GaleMed Corporation]	Latex Breathing Bag	2013-07-31
PMN K103316 | BTT GALEMED XIAMEN CO., LTD. [GaleMed Corporation]	FLOWREST	2013-07-24
PMN K944301 | BTM GALEMED XIAMEN CO., LTD. [GaleMed Corporation]	HUDSON RCI LIFESAVER SINGLE PATIENT USE MANUAL RESUSCITATOR	2012-12-17
PMN K051279 | CAH GALEMED XIAMEN CO., LTD. [GaleMed Corporation]	EXHALOMETER	2012-12-17
PMN K051279 | BZK GALEMED XIAMEN CO., LTD. [GaleMed Corporation]	EXHALOMETER	2012-12-17
PMN K964719 | BTM GALEMED XIAMEN CO., LTD. [GaleMed Corporation]	LIFESAVER SINGLE PATIENT USE MANUAL RESUSCITATOR	2012-03-30
BYD GALEMED XIAMEN CO., LTD. [GaleMed Corporation]	HME	2012-01-10
PMN K902062 | BYE GALEMED XIAMEN CO., LTD. [GaleMed Corporation]	PEEP valve	2011-09-22
PMN K895589 | BTM GALEMED XIAMEN CO., LTD. [GaleMed Corporation]	Manual Resuscitator Durable	2011-05-13
BXJ GALEMED XIAMEN CO., LTD. [GaleMed Corporation]	Clip, Nose	2011-02-09
PMN K102377 | CAP GALEMED XIAMEN CO., LTD. [GaleMed Corporation]	Venti.Plus Disposable Pressure Manometer	2010-12-06
PMN K102377 | CAP GALEMED XIAMEN CO., LTD. [GaleMed Corporation]	Disposable Pressure Manometer	2010-12-06
PMN K082092 | BYE GALEMED XIAMEN CO., LTD. [GaleMed Corporation]	Disposable PEEP Valve	2008-11-05
PMN K082092 | BYE GALEMED XIAMEN CO., LTD. [GaleMed Corporation]	Dispo-Bag Manual Resuscitator	2008-11-05
PMN K082092 | BYE GALEMED XIAMEN CO., LTD. [GaleMed Corporation]	Dispo-BAG Manual Resuscitation Bag	2008-11-05
PMN K082092 | BYE GALEMED XIAMEN CO., LTD. [GaleMed Corporation]	DISPO-BAG Manual Resuscitation Bag with Disposable PEEP Valve	2008-11-05
PMN K082092 | BTM GALEMED XIAMEN CO., LTD. [GaleMed Corporation]	Disposable PEEP Valve	2008-11-05
PMN K082092 | BTM GALEMED XIAMEN CO., LTD. [GaleMed Corporation]	Dispo-Bag Manual Resuscitator	2008-11-05
PMN K082092 | BTM GALEMED XIAMEN CO., LTD. [GaleMed Corporation]	Dispo-BAG Manual Resuscitation Bag	2008-11-05
PMN K082092 | BTM GALEMED XIAMEN CO., LTD. [GaleMed Corporation]	DISPO-BAG Manual Resuscitation Bag with Disposable PEEP Valve	2008-11-05
PMN K991861 | BTM GALEMED XIAMEN CO., LTD. [GaleMed Corporation]	Ventilator, emergency, manual(resus	2008-03-03
PMN K991861 | BTM GALEMED XIAMEN CO., LTD. [GaleMed Corporation]	1ST RESPONSE PEDIATRIC MANUAL RESUSCITATOR	2008-03-03
PMN K991861 | BTM GALEMED XIAMEN CO., LTD. [GaleMed Corporation]	1ST RESPONSE INFANT MANUAL RESUSCITATOR	2008-03-03
PMN K023793 | BTM GALEMED XIAMEN CO., LTD. [GaleMed Corporation]	Ventilator, emergency, manual(resus	2008-03-03
PMN K023793 | BTM GALEMED XIAMEN CO., LTD. [GaleMed Corporation]	1" Response Pediatric Manual Resuscitator, Child large	2008-03-03
PMN K014115 | BTM GALEMED XIAMEN CO., LTD. [GaleMed Corporation]	Ventilator, emergency, manual(resus	2008-03-03
PMN K014115 | BTM GALEMED XIAMEN CO., LTD. [GaleMed Corporation]	1" Response Manual Resuscitator, Adult	2008-03-03
PMN K072755 | BZD GALEMED XIAMEN CO., LTD. [GaleMed Corporation]	NIV Mask	2007-12-19
PMN K072755 | BZD GALEMED XIAMEN CO., LTD. [GaleMed Corporation]	CPAP/VPAP Mask	2007-12-19
PMN K072755 | BZD GALEMED XIAMEN CO., LTD. [GaleMed Corporation]	CPAP Full Mask	2007-12-19
PMN K951043 | BSJ GALEMED XIAMEN CO., LTD. [GaleMed Corporation]	SURE SEAL ANESTHETIC MASK	2007-03-14
PMN K951043 | BSJ GALEMED XIAMEN CO., LTD. [GaleMed Corporation]	Aircushion mask	2007-03-14
PMN K951043 | BSJ GALEMED XIAMEN CO., LTD. [GaleMed Corporation]	Aircushion mask with hook ring	2007-03-14
PMN K021742 | CAF GALEMED XIAMEN CO., LTD. [GaleMed Corporation]	Neb-Easy Nebulizer	2007-03-14
PMN K021742 | CAF GALEMED XIAMEN CO., LTD. [GaleMed Corporation]	GaleMed Large Volume Nebulizer	2007-03-14
PMN K021742 | CAF GALEMED XIAMEN CO., LTD. [GaleMed Corporation]	GALEMED NEBULIZER SET	2007-03-14
PMN K021742 | CAF GALEMED XIAMEN CO., LTD. [GaleMed Corporation]	GALEMED LARGE VOLUME	2007-03-14
CAI GALEMED XIAMEN CO., LTD. [GaleMed Corporation]	VENTILATOR CIRCUIT	2007-03-14
CAI GALEMED XIAMEN CO., LTD. [GaleMed Corporation]	Single limb manifold	2007-03-14
CAI GALEMED XIAMEN CO., LTD. [GaleMed Corporation]	Disposable respiratory circuit	2007-03-14
CAI GALEMED XIAMEN CO., LTD. [GaleMed Corporation]	Disposable anesthesia circuit	2007-03-14
CAE GALEMED XIAMEN CO., LTD. [GaleMed Corporation]	GUEDEL AIRWAY	2007-03-14
CAE GALEMED XIAMEN CO., LTD. [GaleMed Corporation]	COLOR CODED AIRWAYS	2007-03-14
CAE GALEMED XIAMEN CO., LTD. [GaleMed Corporation]	BERMAN AIRWAY	2007-03-14
BZO GALEMED XIAMEN CO., LTD. [GaleMed Corporation]	Silicone breathing hose	2007-03-14
BZO GALEMED XIAMEN CO., LTD. [GaleMed Corporation]	Reusable swivel flex tube	2007-03-14
BZO GALEMED XIAMEN CO., LTD. [GaleMed Corporation]	Oxygen Line Accessory	2007-03-14
BZO GALEMED XIAMEN CO., LTD. [GaleMed Corporation]	GALEMED TUBING	2007-03-14
BZO GALEMED XIAMEN CO., LTD. [GaleMed Corporation]	Disposable corrugate tube	2007-03-14
BZO GALEMED XIAMEN CO., LTD. [GaleMed Corporation]	Carrier Gas Tube Assembly	2007-03-14
BZO GALEMED XIAMEN CO., LTD. [GaleMed Corporation]	Aerosol Tube Assembly	2007-03-14
BZA GALEMED XIAMEN CO., LTD. [GaleMed Corporation]	Reusable wye connector	2007-03-14
BZA GALEMED XIAMEN CO., LTD. [GaleMed Corporation]	Reusable straight connector	2007-03-14
BZA GALEMED XIAMEN CO., LTD. [GaleMed Corporation]	Reusable elbow connector	2007-03-14
BZA GALEMED XIAMEN CO., LTD. [GaleMed Corporation]	In-Line NebTee with Valve	2007-03-14
BZA GALEMED XIAMEN CO., LTD. [GaleMed Corporation]	Disposable wye connector	2007-03-14
BZA GALEMED XIAMEN CO., LTD. [GaleMed Corporation]	Disposable swivel wye connector	2007-03-14
BZA GALEMED XIAMEN CO., LTD. [GaleMed Corporation]	Disposable straight connector	2007-03-14
BZA GALEMED XIAMEN CO., LTD. [GaleMed Corporation]	Disposable elbow connector	2007-03-14
BZA GALEMED XIAMEN CO., LTD. [GaleMed Corporation]	AIRWAY CONNECTOR	2007-03-14
BYG GALEMED XIAMEN CO., LTD. [GaleMed Corporation]	NASAL CPAP MASK	2007-03-14
BYG GALEMED XIAMEN CO., LTD. [GaleMed Corporation]	GALEMED MASK	2007-03-14
BSJ GALEMED XIAMEN CO., LTD. [GaleMed Corporation]	Silicone mask	2004-09-15
BSJ GALEMED XIAMEN CO., LTD. [GaleMed Corporation]	SURE SEAL ANESTHETIC MASK	2004-09-15
BSJ GALEMED XIAMEN CO., LTD. [GaleMed Corporation]	Reusable mask	2004-09-15
BSJ GALEMED XIAMEN CO., LTD. [GaleMed Corporation]	Economy reusable mask	2004-09-15
BSJ GALEMED XIAMEN CO., LTD. [GaleMed Corporation]	Ambu Open Cuff Silicone Face Mask	2004-09-15

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
2020092628949	Xiamen,China (Mainland) -> New York/Newark Area, Newark, New Jersey	MEDICAL EQUIPMENT	100 CTN
202008315332	Xiamen,China (Mainland) -> New York/Newark Area, Newark, New Jersey	MEDICAL EQUIPMENT	25 CTN
2020073119013	Xiamen,China (Mainland) -> New York/Newark Area, Newark, New Jersey	MEDICAL EQUIPMENT	25 CTN
2020073017388	Xiamen,China (Mainland) -> New York/Newark Area, Newark, New Jersey	MEDICAL EQUIPMENT	25 CTN
2020071730298	Xiamen,China (Mainland) -> Long Beach, California	FILTER	90 CTN
2020071445412	Xiamen,China (Mainland) -> Long Beach, California	FILTER	90 CTN
2020070823928	Xiamen,China (Mainland) -> New York/Newark Area, Newark, New Jersey	MEDICAL EQUIPMENT	250 CTN
2020062414448	Xiamen,China (Mainland) -> New York/Newark Area, Newark, New Jersey	MEDICAL EQUIPMENT	40 CTN