Sm Eng Co L T D

FDA Filings

This page includes the latest FDA filings for Sm Eng Co 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 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
SM ENG CO., LTD
REXLENE2018-12-21
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
SM ENG CO., LTD
REXMONO, PDREX2018-03-12
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
SM ENG CO., LTD
REXLON, REXSIL2017-03-02
Vera Au [SM ENG co.,ltd]
CRYLREX?2017-02-13
SM ENG CO., LTD
CRYLREX2017-02-10
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

Related Finance Registrations
U.S. Import Records [external site]
Import IDShipmentCargo DescriptionQuantity
2020050130913Pusan,South Korea -> Oakland, CaliforniaSURGICAL BLADE11 CTN
2019102245659Pusan,South Korea -> Oakland, CaliforniaSURGICAL BLADE16 CTN
2019011742785Pusan,South Korea -> Oakland, CaliforniaSURGICAL BLADE 90189018 PKG
2018111061457Pusan,South Korea -> Oakland, CaliforniaSURGICAL SCAPEL 9018.90-209020 PKG
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