Ga Health Co L T D

FDA Filings

This page includes the latest FDA filings for Ga Health 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: 3011620482
• FEI Number: 3011620482
• Name: GA HEALTH COMPANY LIMITED
• Owner & Operator: GA Health Company Limited
• Contact Address: F3,9 Fuzhong Road, GuanTian District, Longjiang Shunde; Foshan CN-44 Guangdong 528318 CN
• US Agent:
  • David Lennarz
  • REGISTRAR CORP
  • 757 2240177
  • 757 2240179
  • david.lennarz@registrarcorp.com
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: F3,9 Fuzhong Road, GuanTian District, Longjiang Shunde; Foshan Guangdong, 528318 CN
• Establishment Type: Manufacture Medical Device

• Registration Number: 3014749926
• FEI Number: 3014749926
• Name: David Lennarz
• Owner & Operator: GA Health Company Limited
• Contact Address: Unit 18, 21/F, Metropole Square 2 On Yiu Street ,Shatin, N.T; Hong Kong HK-NA None HK
• US Agent:
  • David Lennarz
  • Registrar Corp
  • 757 2240177
  • 757 2240179
  • david.lennarz@registrarcorp.com
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 144 Research Drive ; Hampton, VA 23666 US
• Establishment Type:
  • Export Device to the United States But Perform No Other Operation on Device
  • Foreign Private Label Distributor

FDA Owner/Operator Registration

FDA Filings

Device Company	Device	Date
GUDID 14897106955531 GA Health Company Limited	andorate® Champion 3-piece valve kit	2024-10-17
GUDID 14897106955661 GA Health Company Limited	andorate® Champion 4-piece valve kit	2024-10-14
GUDID 14897106955647 GA Health Company Limited	andorate® Champion 4-piece valve kit	2024-10-14
GUDID 14897106955616 GA Health Company Limited	andorate® Champion 3-piece valve kit	2024-10-14
GUDID 14897106955579 GA Health Company Limited	andorate® Champion 3-piece valve kit	2024-10-14
GUDID 14897106955562 GA Health Company Limited	andorate® Champion 4-piece valve kit	2024-10-14
GUDID 14897106955166 GA Health Company Limited	andorate® Biopsy Valve	2024-10-14
GUDID 14897106954626 GA Health Company Limited	andorate® Suction Valve	2024-10-14
GUDID 04897106953363 GA Health Company Limited	andorate® 2-piece Valve Kit	2024-10-14
GUDID 04897106957040 GA Health Company Limited	andorate® Port Brush	2024-08-15
GUDID 14897106955838 GA Health Company Limited	andorate® Air Water Channel Cleaning Adapter + 4-piece Valve Kit	2023-10-12
GUDID 14897106955821 GA Health Company Limited	andorate® Air Water Channel Cleaning Adapter + 4-piece Valve Kit	2023-10-12
GUDID 14897106955814 GA Health Company Limited	andorate® Air Water Channel Cleaning Adapter + 3-piece Valve Kit	2023-10-12
GUDID 14897106955807 GA Health Company Limited	andorate® Air Water Channel Cleaning Adapter + 4-piece Valve Kit	2023-10-12
GUDID 14897106955791 GA Health Company Limited	andorate® Air Water Channel Cleaning Adapter + 3-piece Valve Kit	2023-10-12
GUDID 14897106955784 GA Health Company Limited	andorate® Air Water Channel Cleaning Adapter + 3-piece Valve Kit	2023-10-12
GUDID 14897106955869 GA Health Company Limited	andorate® CO2 Source Tubing Adapter	2023-09-07
GUDID 14897106955852 GA Health Company Limited	andorate® CO2 Source Tubing Adapter	2023-09-05
GUDID 14897106955746 GA Health Company Limited	andorate® Air Water Channel Cleaning Adapter	2023-06-07
GUDID 14897106955739 GA Health Company Limited	andorate® Biopsy Port Cleaning Adapter	2023-06-07
GUDID 14897106955722 GA Health Company Limited	andorate® Air Water Channel Cleaning Adapter	2023-06-07
GUDID 14897106955753 GA Health Company Limited	2-piece Cleaning Adapter Kit (Non sterile)	2023-04-03
GUDID 14897106951168 GA Health Company Limited	Air/Water Valve	2023-03-23
GUDID 14897106951113 GA Health Company Limited	2-piece valve kit (Suction and Air/Water Valve)	2023-03-23
GUDID 14897106951106 GA Health Company Limited	4-piece valve kit(Suction, Air/Water, Biopsy Valves & Auxiliary Water Connector)	2023-03-23
GUDID 14897106951090 GA Health Company Limited	3-piece valve kit (Suction, Air/Water and Biopsy Valves)	2023-03-23
GUDID 14897106951489 GA Health Company Limited	KEYSURGICAL® PolypTrap with 2 removable chambers	2022-11-28
GUDID 14897106951175 GA Health Company Limited	STOPCON Suction Valve for GI-Endoscope	2022-11-28
PMN K223171 GA Health Company Limited	AquaPulse® Irrigation Tubing	2022-11-10
GUDID 14897106951779 GA Health Company Limited	STOPCON CO2 Source Tubing Adapter	2022-06-10
GUDID 14897106951762 GA Health Company Limited	STOPCON Air/Water Channel Cleaning Adapter	2022-06-10
GUDID 14897106951311 GA Health Company Limited	STOPCON Disposable Auxiliary Water Connector	2022-06-10
GUDID 14897106950109 GA Health Company Limited	andorate® Air/Water Bottle Tubing with Side Port	2022-06-10
GUDID 14897106950062 GA Health Company Limited	andorate® Air/Water Bottle Tubing	2022-06-10
GUDID 04897106950355 GA Health Company Limited	andorate® Disposable Endoscope Valves Set	2022-04-25
GUDID 24897106953671 GA Health Company Limited	andorate® Single Use Tourniquet	2022-04-04
GUDID 14897106955098 GA Health Company Limited	Single Chamber Polyp Trap for Polyp Collection	2022-04-04
GUDID 14897106955074 GA Health Company Limited	Biopsy Valve for Olympus® / Fujinon® GI-Endoscope	2022-04-04
GUDID 14897106955067 GA Health Company Limited	Disposable Four-Chamber Polyp Trap	2022-04-04
GUDID 14897106953643 GA Health Company Limited	andorate® Eye Cornea Protectors	2022-03-10
GUDID 14897106953933 GA Health Company Limited	andorate® Single-end Bronchoscope Cleaning Brush	2022-03-09
GUDID 14897106953636 GA Health Company Limited	andorate® Single-End Tapered Brush	2022-03-09
GUDID 14897106954978 GA Health Company Limited	andorate® Air/Water Bottle Tubing	2022-03-03
GUDID 14897106954954 GA Health Company Limited	andorate® Air/Water Bottle Tubing	2022-03-03
GUDID 14897106954176 GA Health Company Limited	andorate® A/W Channel Cleaning Adapter + 3-piece Valve Kit	2022-03-03
GUDID 14897106954084 GA Health Company Limited	andorate® A/W Channel Cleaning Adapter + 4-piece Valve Kit	2022-03-03
GUDID 14897106954077 GA Health Company Limited	andorate® 4-piece Valve Kit	2022-03-03
GUDID 14897106953797 GA Health Company Limited	andorate® CO2 Extend Tubing with Luer Connector	2022-03-03
GUDID 14897106953773 GA Health Company Limited	andorate® 4-piece Valve Kit	2022-03-03
GUDID 14897106953599 GA Health Company Limited	andorate® Bite Block 66Fr with Strap	2022-03-03
GUDID 14897106953582 GA Health Company Limited	andorate® Bite Block 55.5Fr with Strap	2022-03-03
GUDID 14897106953568 GA Health Company Limited	andorate® Bite Block 66Fr with Oxygen Connection and Tooth Protector	2022-03-03
GUDID 14897106953490 GA Health Company Limited	andorate® Four Chamber Polyp Trap	2022-03-03
GUDID 14897106950369 GA Health Company Limited	andorate® Disposable Endoscope Valves Set	2022-03-02
GUDID 14897106955043 GA Health Company Limited	andorate® Irrigation Tubing	2022-02-08
GUDID 14897106954145 GA Health Company Limited	STOPCON Cap Tubing Pentax® Air/Water Bottle Tubing With CO2 Extend	2022-02-08
GUDID 14897106954138 GA Health Company Limited	STOPCON Disposable Endoscope Valves Set	2022-02-08
GUDID 14897106954121 GA Health Company Limited	STOPCON Jet - Pentax® Auxiliary Water Connector for Pentax® 90/ i10 GI Endoscope	2022-02-08
GUDID 14897106954114 GA Health Company Limited	StopCon-Cap Pentax® Cap with Air/Water tubing for Pentax® GI Endoscope	2022-02-08
GUDID 14897106954107 GA Health Company Limited	STOPCON Biopsy Valve For Pentax® GI-Endoscope	2022-02-08
GUDID 14897106952257 GA Health Company Limited	StopCon-Cap Olympus® Cap with Air/Water tubing for Olympus®	2022-02-08
GUDID 14897106951397 GA Health Company Limited	STOPCON Cap Tubing Olympus® Air / Water Bottle Tubing With CO2 Extend	2022-02-08
GUDID 14897106954985 GA Health Company Limited	andorate® Irrigation Tubing	2022-02-07
GUDID 14897106954787 GA Health Company Limited	andorate® 2-piece Cleaning Adapter + 4-piece Valve Kit	2022-02-07
GUDID 14897106954633 GA Health Company Limited	andorate® Air/Water Valve	2022-02-07
GUDID 14897106954602 GA Health Company Limited	andorate® Suction Valve	2022-02-07
GUDID 14897106954596 GA Health Company Limited	andorate® Suction Valve	2022-02-07
GUDID 14897106953896 GA Health Company Limited	andorate® Biopsy Irrigator	2022-02-07
GUDID 14897106953834 GA Health Company Limited	andorate® 2-piece Valve Kit	2022-02-07
GUDID 14897106953780 GA Health Company Limited	andorate® 3-piece Valve Kit	2022-02-07
GUDID 14897106953544 GA Health Company Limited	andorate® Universal Endoscope Tip Guard	2022-02-07
GUDID 14897106952899 GA Health Company Limited	andorate® Universal Endoscope Tip Guard	2022-02-07
GUDID 14897106950253 GA Health Company Limited	andorate® Air/Water Valve	2022-02-07
GUDID 14897106950246 GA Health Company Limited	andorate® Suction Valve	2022-02-07
GUDID 14897106954930 GA Health Company Limited	andorate® Air/Water Bottle Tubing with Side Port	2022-01-21
GUDID 14897106954466 GA Health Company Limited	andorate® Air/Water Bottle Tubing	2022-01-21
GUDID 14897106953766 GA Health Company Limited	andorate® 4-piece Valve Kit	2022-01-21
GUDID 14897106953926 GA Health Company Limited	andorate® 4-piece Valve Kit	2022-01-20
GUDID 14897106953919 GA Health Company Limited	andorate® 3-piece Valve Kit	2022-01-20
GUDID 14897106953810 GA Health Company Limited	andorate® 2-piece Cleaning Adapter Kit	2022-01-20
GUDID 14897106953803 GA Health Company Limited	andorate® A/W Channel Cleaning Adapter + 4-piece Valve Kit	2022-01-20
GUDID 14897106954046 GA Health Company Limited	andorate® 3-piece Valve Kit	2022-01-19
GUDID 14897106954039 GA Health Company Limited	andorate® 2-piece Valve Kit	2022-01-19
GUDID 14897106954022 GA Health Company Limited	andorate® 3-piece Valve Kit	2022-01-19
GUDID 14897106953759 GA Health Company Limited	andorate® Biopsy Valve	2022-01-19
GUDID 14897106954435 GA Health Company Limited	andorate® Air/Water Bottle Tubing	2022-01-18
GUDID 14897106954008 GA Health Company Limited	andorate® Biopsy Valve	2022-01-18
GUDID 14897106953902 GA Health Company Limited	andorate® Biopsy Valve	2022-01-18
GUDID 14897106953889 GA Health Company Limited	andorate® 2-piece Valve Kit	2022-01-18
GUDID 14897106953735 GA Health Company Limited	andorate® 3-piece Valve Kit	2022-01-18
PMN K213095 GA Health Company Limited	Andorate Suction Valve, Andorate Air/Water Valve	2022-01-12
GUDID 14897106950314 GA Health Company Limited	andorate® Disposable Endoscope Valves Set	2022-01-12
GUDID 14897106950321 GA Health Company Limited	andorate® Disposable Endoscope Valves Set	2022-01-11
GUDID 14897106950239 GA Health Company Limited	andorate® Disposable Endoscope Valves Set	2022-01-11
GUDID 14897106950222 GA Health Company Limited	andorate® Disposable Endoscope Valves Set	2022-01-11
GUDID 14897106950024 GA Health Company Limited	andorate® Air/Water Bottle Tubing	2022-01-11
GUDID 14897106950505 GA Health Company Limited	andorate® Auxiliary Water Connector	2022-01-07
GUDID 14897106950260 GA Health Company Limited	Andorate® 4-piece Valve Kit	2022-01-07
GUDID 14897106950185 GA Health Company Limited	andorate® Air/Water Bottle Tubing with CO2 Extend	2022-01-07
GUDID 14897106950147 GA Health Company Limited	andorate® Air/Water Bottle Tubing with CO2 Extend	2022-01-07
GUDID 14897106950086 GA Health Company Limited	andorate® Air/Water Bottle Tubing with CO2 Extend	2022-01-07
GUDID 14897106950048 GA Health Company Limited	andorate® Air/Water Bottle Tubing with CO2 Extend	2022-01-07
PMN K202838 GA Health Company Limited	Andorate Universal Endoscope Tip Guard	2021-03-05
PMN K202560 GA Health Company Limited	AquaPulse Irrigation Tubing	2020-12-10
PMN K200495 GA Health Company Limited	Andorate Disposable Air/Water Valve, Andorate Disposable Suction Valve	2020-06-24
PMN K200481 GA Health Company Limited	Andorate Biopsy Valve, Andorate Biopsy Irrigator	2020-06-18
PMN K200479 GA Health Company Limited	AquaPulse Auxiliary Water Connector	2020-05-15
PMN K200388 GA Health Company Limited	Vacutore Air/Water Bottle Tubing, Vacutore CO2 Tubing With Luer Connector	2020-04-14
PMN K200388 | OCX David Lennarz [GA Health Company Limited]	Vacutore CO2 Source Tubing with Luer Connector	2020-04-14
PMN K200388 | OCX David Lennarz [GA Health Company Limited]	Vacutore Air/Water Bottle Tubing	2020-04-14
PMN K200388 | FCX David Lennarz [GA Health Company Limited]	Vacutore CO2 Source Tubing with Luer Connector	2020-04-14
PMN K200388 | FCX David Lennarz [GA Health Company Limited]	Vacutore Air/Water Bottle Tubing	2020-04-14
MNL GA HEALTH COMPANY LIMITED	Cleaning Brush	2017-12-27
MNK GA HEALTH COMPANY LIMITED	Bite Block	2017-12-27
HMP GA HEALTH COMPANY LIMITED	Surgical Eye Cover	2017-12-27
GAX GA HEALTH COMPANY LIMITED	Tourniquet	2017-12-27
CBC GA HEALTH COMPANY LIMITED	Polyp Trap	2017-12-27

Similar & Related FDA Registered Companies

• Ganzhou Hongfei medical and health materials Co., Ltd
• Gauke Healthcare Co., Ltd
• GA Health and Beauty (FOSHAN) Co., Ltd

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
2020092147407	Shanghai ,China (Mainland) -> Los Angeles, California	DISPOSABLE ENDOSCOPE VALVES SET	185 CTN
202008189664	Shanghai ,China (Mainland) -> Long Beach, California	DISPOSABLE ENDOSCOPE VALVES SET	29 PKG
2020073045416	Shanghai ,China (Mainland) -> Long Beach, California	DISPOSABLE ENDOSCOPE VALVES SET	29 PKG
2020072842365	Shanghai ,China (Mainland) -> Long Beach, California	DISPOSABLE ENDOSCOPE VALVES SET	29 PKG
2020070617066	Shanghai ,China (Mainland) -> New York/Newark Area, Newark, New Jersey	DISPOSABLE ENDOSCOPE VALVES SET	12 CTN
2020061725846	Shanghai ,China (Mainland) -> New York/Newark Area, Newark, New Jersey	DISPOSABLE ENDOSCOPE VALVES SET	11 CTN
2020061037456	Shanghai ,China (Mainland) -> Seattle, Washington	BIOPSY VALVE BIOPSY VALVE FOR PENTAX GI-ENDOSCOPE	8 PKG
2020060952366	Shanghai ,China (Mainland) -> Seattle, Washington	BIOPSY VALVE BIOPSY VALVE FOR PENTAX GI-ENDOSCOPE	8 PKG