Johan Van Dalen

FDA Filings

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

FDA Registration(s)
Registration Number9617582
FEI Number3003272824
NameJohan Van Dalen
Owner & OperatorPIETRASANTA PHARMA SpA
Contact AddressVIA S. FRANCESCO NO. 67 --
VIAREGGIO IT-LU Lucca 55049 IT
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address3391 E. Hemisphere Loop
Tucson, AZ 85706 US
Establishment TypeManufacture Medical Device



Registration Number9615150
FEI Number1000618080
NameJohan Van Dalen
Owner & OperatorOptego Vision
Contact Address3600 B. Laird Drive Unit 3
Mississauga CA-ON Ontario l5l 6a7 CA
Official Correspondent
  • Johan - Van Dalen
  • 1-905-8281919-x
US Agent
Importing Logistics Registration
ImporterNova southeastern University
Address3301 College avenue
Fort Lauderdale, FL 33314 UNITED STATES
Importer TypeEnd User
Importing Logistics Registration
ImporterPioneer International
Address361 Airport Drive, joliet
Joliet, IL 60431 UNITED STATES
Importer TypeRetailer
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address3391 E. Hemisphere Loop
Tucson, AZ 85706 US
Establishment TypeExport Device to the United States But Perform No Other Operation on Device



FDA Filings

Device
Company
DeviceDate
Johan Van Dalen [PIETRASANTA PHARMA SpA]
IDRA Hydrogel2020-01-10
Johan Van Dalen [Optego Vision]
Optego Stock Spherical Flippers2019-04-01
Johan Van Dalen [Optego Vision]
Optego Stock Prism Flippers2019-04-01
Johan Van Dalen [Optego Vision]
Optego Home Therapy Flippers2019-04-01
Johan Van Dalen [Optego Vision]
Optego Diagnostic Flippers2019-04-01
Johan Van Dalen [PIETRASANTA PHARMA SpA]
MASTER AID-STERIBLOCK2003-12-22
Johan Van Dalen [PIETRASANTA PHARMA SpA]
Rollflex2003-09-10
Johan Van Dalen [PIETRASANTA PHARMA SpA]
MASTER AID TAPE2003-09-10
Johan Van Dalen [PIETRASANTA PHARMA SpA]
Cutiflex2003-09-10
Johan Van Dalen [PIETRASANTA PHARMA SpA]
Ortopad2001-01-29
Johan Van Dalen [PIETRASANTA PHARMA SpA]
Ortolux2001-01-29
Johan Van Dalen [PIETRASANTA PHARMA SpA]
OPTOMED-MASTER-AID2001-01-29
Johan Van Dalen [Optego Vision]
OPTEGO READERS1999-12-01

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