Visionflex Pty L T D

FDA Filings

This page includes the latest FDA filings for Visionflex Pty L T D. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

• Registration Number: 3012828634
• FEI Number: 3012828634
• Name: Brenda McGivern
• Owner & Operator: Visionflex Pty Limited
• Contact Address: 1/8 Prosperity Parade Warriewood ; Sydney AU-NSW New South Wales 2102 AU
• US Agent:
  • Brenda McGivern
  • Brenda J McGivern CPA
  • 781 3410930 11
  • 781 3449187
  • brenda@bmcgiverncpa.com
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 532 Page Street ; Stoughton, MA 02072 US
• Establishment Type:
  • Export Device to the United States But Perform No Other Operation on Device
  • Complaint File Establishment per 21 CFR 820.198

FDA Filings

Device Company	Device	Date
GUDID 09352527001314 VISIONFLEX PTY. LTD.	Visionflex	2021-03-01
GUDID 09352527001307 VISIONFLEX PTY. LTD.	Visionflex	2021-03-01
GUDID 09352527001161 VISIONFLEX PTY. LTD.	Visionflex	2021-03-01
GUDID 09352527000775 VISIONFLEX PTY. LTD.	Visionflex	2020-08-25
GUDID 09352527000669 VISIONFLEX PTY. LTD.	Visionflex	2020-08-25
GUDID 09352527000614 VISIONFLEX PTY. LTD.	Visionflex	2020-08-25
GUDID 09352527000607 VISIONFLEX PTY. LTD.	Visionflex	2020-08-25
GUDID 09352527000591 VISIONFLEX PTY. LTD.	Visionflex	2020-08-25
GUDID 09352527000584 VISIONFLEX PTY. LTD.	Visionflex	2020-08-25
GUDID 09352527000577 VISIONFLEX PTY. LTD.	Visionflex	2020-08-25
GUDID 09352527000560 VISIONFLEX PTY. LTD.	Visionflex	2020-08-25
GUDID 09352527000553 VISIONFLEX PTY. LTD.	Visionflex	2020-08-25
PMN K132953 | PEM Brenda McGivern [Visionflex Pty Limited]	Tidishield	2017-07-26
FXG Brenda McGivern [Visionflex Pty Limited]	Riester Specula- Otoscope	2017-07-26
FWL Brenda McGivern [Visionflex Pty Limited]	Universal FSC2 Camera Handpiece	2017-07-26
FWL Brenda McGivern [Visionflex Pty Limited]	LED Light Source - USB	2017-07-26
FWL Brenda McGivern [Visionflex Pty Limited]	Intra Oral Camera Lercher	2017-07-26
FWL Brenda McGivern [Visionflex Pty Limited]	GEIS - HD General Exam Camera	2017-07-26
FWL Brenda McGivern [Visionflex Pty Limited]	FV-HD Base	2017-07-26
FWL Brenda McGivern [Visionflex Pty Limited]	FSC3 Multi functional Camera Handpiece	2017-07-26
FWL Brenda McGivern [Visionflex Pty Limited]	Endoscope Camera with Adaptor - SD	2017-07-26
FWL Brenda McGivern [Visionflex Pty Limited]	Endoscope Camera Head HD Zoom	2017-07-26
PMN K132560 | DQD Brenda McGivern [Visionflex Pty Limited]	RNK PCP-USB Stethoscope	2017-07-18
OUG Brenda McGivern [Visionflex Pty Limited]	ProEX	2017-06-28
OUG Brenda McGivern [Visionflex Pty Limited]	ProEX Mobile	2017-06-28
KAK Brenda McGivern [Visionflex Pty Limited]	Visionflex Pty Limited	2016-04-17
EIX Brenda McGivern [Visionflex Pty Limited]	Visionflex Pty Limited	2016-04-17

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
201911233236	Sydney,Australia -> Philadelphia, Pennsylvania	SLAC: BIG HORUS SCOPES - MEDICAL DEVICES LOWEST HBL: S02635343 SCAC: SHPT HS CODE: 852580	1 CTN