E J Smith

FDA Filings

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

FDA Registration(s)

• Registration Number: 3011688715
• FEI Number: 3011688715
• Name: E.J. Smith
• Owner & Operator: Sonoscanner
• Contact Address: 16192 Coastal Hwy ; Lewes DE 19958 US
• Official Correspondent:
  • Etienne Richard
  • x-866-9392427-x
• US Agent:
  • E.J. Smith
  • Smith Associates
  • 410 4510639
  • 410 7930448
  • esmith@fdaconsultants.com
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 1468 Hardwell Avenue ; Crofton, MD 21114 US
• Establishment Type: Manufacture Medical Device

• Registration Number: 3006891655
• FEI Number: 3006891655
• Name: E.J. Smith
• Owner & Operator: Seisa Europe s.r.o.
• Contact Address: priemyselna 4 ; Myjava SK-TC Trenciansky kraj 90701 SK
• Official Correspondent:
  • Miroslava Janechova
  • 421-34-6999202-103
• US Agent:
  • E.J. Smith
  • SEISA MEDICAL / Smith Associates
  • 888 7299674
  • 410 7930448
  • esmith@fdaconsultants.com
• Importing Logistics Registration:
  • Importer: Cook Ireland LTD
  • Address: O'Halloran Road, National Technology Park ; Limerck, 00000 IRELAND
  • Importer Type: Retailer
  • Subdivision: IE-LK
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: Crofton, MD 21114 Crofton, Maryland, 21114, UNITED STATES; Crofton, MD 21114 US
• Establishment Type: Manufacture Medical Device for Another Party (Contract Manufacturer)

FDA Filings

Device Company	Device	Date
PMN K171164 | IYO E.J. Smith [Sonoscanner]	U-Lite EXP	2017-10-16
PMN K171164 | IYO E.J. Smith [Sonoscanner]	InVisus EXP	2017-10-16
PMN K171164 | IYN E.J. Smith [Sonoscanner]	U-Lite EXP	2017-10-16
PMN K171164 | IYN E.J. Smith [Sonoscanner]	InVisus EXP	2017-10-16
PMN K171164 | ITX E.J. Smith [Sonoscanner]	U-Lite EXP	2017-10-16
PMN K171164 | ITX E.J. Smith [Sonoscanner]	InVisus EXP	2017-10-16
PMN K143601 | IYO E.J. Smith [Sonoscanner]	U-Lite	2015-05-02
PMN K143601 | IYO E.J. Smith [Sonoscanner]	InVisus SLP	2015-05-02
PMN K143601 | IYN E.J. Smith [Sonoscanner]	U-Lite	2015-05-02
PMN K143601 | IYN E.J. Smith [Sonoscanner]	InVisus SLP	2015-05-02
PMN K143601 | ITX E.J. Smith [Sonoscanner]	U-Lite	2015-05-02
PMN K143601 | ITX E.J. Smith [Sonoscanner]	InVisus SLP	2015-05-02
PMN K040151 | FGE E.J. Smith [Seisa Europe s.r.o.]	oasis biliary stent introduction sy	2007-12-28

Similar & Related FDA Registered Companies

• SEISA MEDICAL / Smith Associates
• Smith Associates

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
20200811110131	Yantian,China (Mainland) -> Los Angeles, California	SLAP BRACELET	1 PCS
20200811111852	Yantian,China (Mainland) -> Los Angeles, California	SLAP BRACELET	1 PCS