Epic Medical Pte L T D

FDA Filings

This page includes the latest FDA filings for Epic Medical Pte 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: 3012429465
• FEI Number: 3012429465
• Name: David Lennarz
• Owner & Operator: Epic Medical Pte Ltd
• Contact Address: 105 Cecil Street #20-01 The Octagon; Singapore SG-01 Central Singapore 069534 SG
• US Agent:
  • David Lennarz
  • REGISTRAR CORP
  • 757 2240177
  • 757 2240179
  • david.lennarz@registrarcorp.com
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 144 Research Drive ; Hampton, VA 23666 US
• Establishment Type: Manufacture Medical Device

FDA Filings

Device Company	Device	Date
PMN K201626 Epic Medical Pte. Ltd.	Safety Subcutaneous Infusion Set	2021-03-24
PMN K192075 Epic Medical Pte. Ltd.	ProSeal™ Closed System Drug Transfer Device (CSTD)	2020-08-07
NEP David Lennarz [Epic Medical Pte Ltd]	SMARTeZ Pharmacy Filling Pump	2018-02-01
KYX David Lennarz [Epic Medical Pte Ltd]	SMARTeZ Fluid Transfer Set	2017-12-13
PMN K151650 | MEB David Lennarz [Epic Medical Pte Ltd]	SMARTeZ Pump	2016-04-05
PMN K151650 Epic Medical Pte Ltd	SMARTez Elastomeric Infusion Pump	2016-04-04