Smartmedics Sp Z O O

FDA Filings

This page includes the latest FDA filings for Smartmedics Sp Z O 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: 3016096088
• FEI Number: 3016096088
• Name: SMARTMEDICS SP. Z O.O.
• Owner & Operator: SMARTMEDICS SP. Z O.O.
• Contact Address: Ul. PULAWSKA 12 / 3 ; Warsaw PL-MZ Mazowieckie 02-566 PL
• Official Correspondent:
  • Adrian Maciejewski
  • 48-519-190854-x
• US Agent:
  • Bill Righter
  • Righter Consulting Group LLC
  • 503 4471236
  • bill@righter.us
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: Ul. PULAWSKA 12 / 3 ; Warsaw Mazowieckie, 02-566 PL
• Establishment Type: Manufacture Medical Device

FDA Filings

Device Company	Device	Date
DRX SMARTMEDICS SP. Z O.O.	SmartMedics Precordial ECG Patch	2019-11-04
DRX SMARTMEDICS SP. Z O.O.	SmartMedics MCT Patch	2019-11-04
DRX SMARTMEDICS SP. Z O.O.	SmartMedics EASI Patch	2019-11-04
DRX SMARTMEDICS SP. Z O.O.	SmartMedics 18-lead ECG Patch	2019-11-04
DRX SMARTMEDICS SP. Z O.O.	SmartMedics 12-lead ECG Patch	2019-11-04