Summer Lan

FDA Filings

This page includes the latest FDA filings for Summer Lan. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)
Registration Number3012804266
FEI Number3012804266
NameSummer Lan
Owner & OperatorShenzhen Medke Technology Co., Ltd.
Contact Address4/F,Bldg.A1,Anle Ind. Zone,Hangcheng RD.
Shenzhen CN-44 Guangdong 518126 CN
Official Correspondent
  • Tate Zhuo
  • 086-755-23463462-x
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address2615 Woodwick Dr, Sugar Land, TX 77479
Sugar Land, TX 77479 US
Establishment TypeManufacture Medical Device



Registration Number3015972771
FEI Number3015972771
NameSummer Lan
Owner & OperatorHuman Metabolomics Institute, Inc.
Contact AddressSuite 501D1, Building E, Gangzhilong Science and Technology Park,
Shenzhen CN-44 Guangdong 518109 CN
Official Correspondent
  • Xiaoxia Yang
  • 86-134-80962674-x
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address2615 Woodwick Dr
Sugar Land, TX 77479 US
Establishment TypeManufacture Medical Device



FDA Filings

Device
Company
DeviceDate
Summer Lan [Shenzhen Medke Technology Co., Ltd.]
Patient Cable2019-12-01
Summer Lan [Human Metabolomics Institute, Inc.]
Liver Steatosis Risk Assessment Software2019-10-12
Summer Lan [Human Metabolomics Institute, Inc.]
Liver Fibrosis and Cirrhosis Risk Assessment Software2019-10-12
Summer Lan [Human Metabolomics Institute, Inc.]
Chronic Liver Disease Risk Assessment Software2019-10-12
Summer Lan [Human Metabolomics Institute, Inc.]
L-Tyrosine and Taurocholic Acid Assay Kit (Liquid Chromatography-Tandem Mass Spectrometry)2019-10-12
Summer Lan [Shenzhen Medke Technology Co., Ltd.]
Medke Spo2 sensor, P11919-01, P12019-01, P12119-01, P12219-01, P12319-01, P12419-01, P8119, P91192016-11-16
Summer Lan [Shenzhen Medke Technology Co., Ltd.]
Medke Spo2 sensor, P11019-01, P11119-01, P11219-01, P11319-01, P11419-01, P11519-01, P11619-01, P11719-01, P11819-012016-11-16
Summer Lan [Shenzhen Medke Technology Co., Ltd.]
Medke Spo2 sensor, P1019-01, P1119-01, P1219-01, P1319-01, P1419-01, P1519-01, P1619-01, P1719-01, P1819-01, P1919-012016-11-16

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