Weian

FDA Filings

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

FDA Registration(s)
Registration Number0
FEI Number0
NameWeian
Owner & OperatorShandong Hismer Medical Device Co., Ltd
Contact AddressWest end of Jinyang Street (South to Xim
Taian CN-37 Shandong 271400 CN
Official Correspondent
  • kai chen
  • 86-538-6085538-x
US Agent
  • Weian
  • 949 4624543
  • weian@isosh.com
Registration Status5
Initial ImporterN
Registration Expiration2020-04-25
Registration Address430 Oakbrook Dr, Columbus, IN 47201
Columbus, IN 47201 US
Establishment TypeManufacture Medical Device



Registration Number0
FEI Number0
NameWeian
Owner & OperatorAvioq Bio-tech Co., Ltd.
Official Correspondent
  • Libo Yan
  • 86-0535-6707585-x
US Agent
  • Weian
  • 194 9462454 3
  • weian@isosh.com
Registration Status5
Initial ImporterN
Registration Expiration2020-04-25
Registration Address430 Oakbrook Dr, Columbus, IN 47201,USA
Columbus, IN 47201 US
Establishment TypeManufacture Medical Device



Registration Number0
FEI Number0
NameWeian
Owner & OperatorQingdao Huaren Medical Product Co.,Ltd.
Contact AddressNo.187 Zhuzhou Road, Qingdao City, China
Qingdao CN-37 Shandong 266101 CN
Official Correspondent
  • Junjie Wang
  • 86-053-8870562-x
US Agent
Registration Status5
Initial ImporterN
Registration Expiration2020-04-25
Registration Address430 Oakbrook Dr, Columbus
Columbus, IN 47201 US
Establishment TypeManufacture Medical Device



FDA Filings

Device
Company
DeviceDate
Weian [Avioq Bio-tech Co., Ltd.]
Novel Coronavirus (COVID-2019) IgG/IgM Assay(Colloidal Gold)2020-04-13
Weian [Qingdao Huaren Medical Product Co.,Ltd.]
N95,Mask:HRKMB-C2020-04-01
Weian [Qingdao Huaren Medical Product Co.,Ltd.]
N95,Mask:HRKMA-C2020-04-01

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