Humanoptics Ag

FDA Filings

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

GERMANY

FRANKFURT STOCK EXCHANGE

H9O1

DUNS 326947129

FDA Registration(s)

• Registration Number: 3010531293
• FEI Number: 3010531293
• Name: Barbara S. Fant
• Owner & Operator: HumanOptics AG
• Contact Address: Westerwaldstr. 11-13 ; Sankt Augustin DE-NW Nordrhein-Westfalen 53757 DE
• Official Correspondent:
  • Pierre Billardon
  • 49-913-150665-55
• US Agent:
  • Barbara S. Fant
  • Clinical Research Consultants, Inc.
  • 513 9618200
  • 513 9612858
  • bsfant@crc-regulatory.com
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 3308 Jefferson Ave Upper Level; Cincinnati, OH 45220 US
• Establishment Type: Manufacture Medical Device

FDA Filings

Device Company	Device	Date
PMA P170039S003 HumanOptics AG	CustomFlex ArtificialIris	2020-09-04
GUDID 04049154000029 HumanOptics AG	Artificial Iris Fiber Free 00095002	2019-10-10
GUDID 04049154000012 HumanOptics AG	Artificial Iris with Fiber 00095001	2019-10-10
PMN P170039 | QBT Barbara S. Fant [HumanOptics AG]	CUSTOMFLEX ARTIFICIAL IRIS	2018-09-10