Steris Ast Sk S R O

FDA Filings

This page includes the latest FDA filings for Steris Ast Sk S R O. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

• Registration Number: 3006610707
• FEI Number: 3006610707
• Name: STERIS AST SK S.R.O.
• Owner & Operator: STERIS Corporation
• Contact Address: 5960 Heisley Road ; Mentor OH 44060 US
• Official Correspondent:
  • Becky Aldhizer
  • x-440-3927490-x
• US Agent:
  • Becky Aldhizer
  • Synergy Health
  • 440 3927490
  • Becky_Aldhizer@steris.com
• Importing Logistics Registration:
  • Importer: Convatec
  • Address: 211 american ave ; Greensboro, NC 27409 UNITED STATES
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: PRIEMYSELNY PARK 6020/5 ; MICHALOVCE Kosicky kraj, 07101 SK
• Establishment Type: Sterilize Medical Device for Another Party (Contract Sterilizer)

FDA Filings

Device Company	Device	Date
PMN K063367 | HIF STERIS AST SK S.R.O. [STERIS Corporation]	Flex Medical WOM-F114 RTP (US)	2017-04-05
PMN K063367 | HIF STERIS AST SK S.R.O. [STERIS Corporation]	Flex Medical WOM-F114 HIGHFlow II(US)	2017-04-05
PMN K063367 | HIF STERIS AST SK S.R.O. [STERIS Corporation]	Flex Medical WOM-F114 HEATED (US)	2017-04-05
PMN K063367 | HIF STERIS AST SK S.R.O. [STERIS Corporation]	Flex Medical WOM-1200999	2017-04-05
PMN K063367 | HIF STERIS AST SK S.R.O. [STERIS Corporation]	Flex Medical WOM-1200997	2017-04-05
PMN K063367 | HIF STERIS AST SK S.R.O. [STERIS Corporation]	Flex Medical WOM-1200457	2017-04-05
PMN K063367 | HIF STERIS AST SK S.R.O. [STERIS Corporation]	Flex Medical WOM-120001	2017-04-05
PMN K063367 | HIF STERIS AST SK S.R.O. [STERIS Corporation]	Flex Medical W.O.M. WORLD OF MEDICNE AG	2017-04-05
PMN K063367 | HIF STERIS AST SK S.R.O. [STERIS Corporation]	Flex Medical Tubing Set H111/M111 Integrated (Inflow/Outflow)	2017-04-05
PMN K022449 | HIG STERIS AST SK S.R.O. [STERIS Corporation]	Flex Medical WOM-F114 RTP (US)	2017-04-05
PMN K022449 | HIG STERIS AST SK S.R.O. [STERIS Corporation]	Flex Medical WOM-F114 HIGHFlow II(US)	2017-04-05
PMN K022449 | HIG STERIS AST SK S.R.O. [STERIS Corporation]	Flex Medical WOM-F114 HEATED (US)	2017-04-05
PMN K022449 | HIG STERIS AST SK S.R.O. [STERIS Corporation]	Flex Medical WOM-1200999	2017-04-05
PMN K022449 | HIG STERIS AST SK S.R.O. [STERIS Corporation]	Flex Medical WOM-1200997	2017-04-05
PMN K022449 | HIG STERIS AST SK S.R.O. [STERIS Corporation]	Flex Medical WOM-1200457	2017-04-05
PMN K022449 | HIG STERIS AST SK S.R.O. [STERIS Corporation]	Flex Medical WOM-120001	2017-04-05
PMN K022449 | HIG STERIS AST SK S.R.O. [STERIS Corporation]	Flex Medical W.O.M. WORLD OF MEDICNE AG	2017-04-05
PMN K022449 | HIG STERIS AST SK S.R.O. [STERIS Corporation]	Flex Medical Tubing Set H111/M111 Integrated (Inflow/Outflow)	2017-04-05
GCD STERIS AST SK S.R.O. [STERIS Corporation]	Medline - Connector	2014-11-14
GCD STERIS AST SK S.R.O. [STERIS Corporation]	D.O.R.C. Dutch Ophthalmic Research Center - DMEK instruments and pack	2014-11-14
GCY STERIS AST SK S.R.O. [STERIS Corporation]	Summit Medical - Replacement Collection Bag	2013-01-17