Vera Au

FDA Filings

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

FDA Registration(s)
Registration Number3008912461
FEI Number3008912461
NameVera Au
Owner & OperatorSM ENG co.,ltd
Contact Address46,Nakdong-daero 1302beon-gil, Sasang-gu
Busan KR-26 Busan Gwangyeogsi 46910 KR
Official Correspondent
  • Gil-Soo Lee
  • 82-10-38311493-x
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address1296 Kifer Rd Sunnyvale, CA 94086, USA
Sunnyvale, CA 94086 US
Establishment Type
  • Complaint File Establishment per 21 CFR 820.198
  • Manufacture Medical Device



FDA Filings

Device
Company
DeviceDate
Vera Au [SM ENG co.,ltd]
REXLENE2019-01-08
Vera Au [SM ENG co.,ltd]
REXMONO?2018-07-16
Vera Au [SM ENG co.,ltd]
PDREX?2018-07-16
Vera Au [SM ENG co.,ltd]
REXMONO?2018-07-16
Vera Au [SM ENG co.,ltd]
PDREX?2018-07-16
Vera Au [SM ENG co.,ltd]
REXSIL?2017-03-14
Vera Au [SM ENG co.,ltd]
REXLON?2017-03-14
Vera Au [SM ENG co.,ltd]
OSSLON2017-03-14
Vera Au [SM ENG co.,ltd]
OSILK2017-03-14
Vera Au [SM ENG co.,ltd]
REXSIL?2017-03-14
Vera Au [SM ENG co.,ltd]
REXLON?2017-03-14
Vera Au [SM ENG co.,ltd]
OSSLON2017-03-14
Vera Au [SM ENG co.,ltd]
OSILK2017-03-14
Vera Au [SM ENG co.,ltd]
CRYLREX?2017-02-13
Vera Au [SM ENG co.,ltd]
NEEDLE, TONSIL SUTURING2014-09-02
Vera Au [SM ENG co.,ltd]
NEEDLE, OPHTHALMIC SUTURING2014-09-02
Vera Au [SM ENG co.,ltd]
NEEDLE, CERCLAGE, GYNECOLOGICAL2014-09-02
Vera Au [SM ENG co.,ltd]
NEEDLE, NEUROSURGICAL SUTURE2014-09-02
Vera Au [SM ENG co.,ltd]
NEEDLE, DENTAL2014-09-02
Vera Au [SM ENG co.,ltd]
NEEDLE, SUTURING, REUSABLE2014-06-05
Vera Au [SM ENG co.,ltd]
NEEDLE, SUTURING, DISPOSABLE2014-06-05
Vera Au [SM ENG co.,ltd]
BLADE and SCALPEL, SURGICAL2014-05-14
Vera Au [SM ENG co.,ltd]
EASYTAP SM-35W2013-07-24

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