Gynius Plus Ab

FDA Filings

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

FDA Registration(s)
Registration Number3014982233
FEI Number3014982233
NameGYNIUS PLUS AB
Owner & OperatorGynius Plus AB
Contact AddressMedicinaregaten 8A
Goteborg SE-O Vastra Gotalands lan [SE-14] 41390 SE
Official Correspondent
  • Huaqing Li
  • 46-704-30444-x
US Agent
Importing Logistics Registration
ImporterScene Capture Inc
Address865 Anthony Dr.
Lindenhurst, NY 11757 UNITED STATES
Importer TypeBroker
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration AddressMedicinaregaten 8A
Goteborg Vastra Gotalands lan [SE-14], 41390 SE
Establishment TypeDevelop Specifications But Do Not Manufacture At This Facility



FDA Filings

Device
Company
DeviceDate
GYNIUS PLUS AB
Gynocular colposcope2018-11-21

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