Kerecis Ehf

FDA Filings

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

FDA Registration(s)

• Registration Number: 3013281127
• FEI Number: 3013281127
• Name: Kerecis Arlington
• Owner & Operator: Kerecis ehf
• Contact Address: Eyrargata 2 ; Isafjordur IS-4 Vestfiroir 400 IS
• Official Correspondent:
  • Fertram Sigurjonsson
  • 354-8-494960-x
• Registration Status: 1
• Initial Importer: Y
• Registration Expiration: 2020-04-25
• Registration Address: 2200 Clarendon Boulevard Suite 1400A; Arlington, VA 22201 US
• Establishment Type: Complaint File Establishment per 21 CFR 820.198

• Registration Number: 3010600625
• FEI Number: 3010600625
• Name: KERECIS EHF
• Owner & Operator: Kerecis ehf
• Contact Address: Eyrargata 2 ; Isafjordur IS-4 Vestfiroir 400 IS
• Official Correspondent:
  • Fertram Sigurjonsson
  • 354-8-494960-x
• US Agent:
  • Gudmundur Fertram Sigurjonsson
  • Kerecis LLC
  • 703 2878752
  • gfs@kerecis.com
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: Eyrargata 2 ; Isafjordur Vestfiroir, 400 IS
• Establishment Type:
  • Complaint File Establishment per 21 CFR 820.198
  • Manufacture Medical Device

FDA Filings

Device Company	Device	Date
PMN K190528 | KGN Kerecis Arlington [Kerecis ehf]	MariGen Wound Extra	2019-10-21
PMN K190528 | KGN Kerecis Arlington [Kerecis ehf]	Kerecis Burn	2019-10-21
PMN K190528 | KGN KERECIS EHF	MariGen Wound Extra	2019-10-21
PMN K190528 | KGN KERECIS EHF	Kerecis Burn	2019-10-21
PMN K153364 | OXE KERECIS EHF	Kerecis SecureMesh	2016-11-21
PMN K132343 | KGN Kerecis Arlington [Kerecis ehf]	Marigen Omega3	2013-11-12
PMN K132343 | KGN Kerecis Arlington [Kerecis ehf]	Marigen Omega3 Wound	2013-11-12
PMN K132343 | KGN Kerecis Arlington [Kerecis ehf]	MariGen	2013-11-12
PMN K132343 | KGN Kerecis Arlington [Kerecis ehf]	MariGen Wound	2013-11-12
PMN K132343 | KGN Kerecis Arlington [Kerecis ehf]	Kerecis Omega3	2013-11-12
PMN K132343 | KGN Kerecis Arlington [Kerecis ehf]	Kerecis Omega3 Wound	2013-11-12
PMN K132343 | KGN Kerecis Arlington [Kerecis ehf]	Alphaplex with MariGen Wound	2013-11-12
PMN K132343 | KGN KERECIS EHF	Marigen Omega3	2013-11-12
PMN K132343 | KGN KERECIS EHF	Marigen Omega3 Wound	2013-11-12
PMN K132343 | KGN KERECIS EHF	MariGen	2013-11-12
PMN K132343 | KGN KERECIS EHF	MariGen Wound	2013-11-12
PMN K132343 | KGN KERECIS EHF	Kerecis Omega3	2013-11-12
PMN K132343 | KGN KERECIS EHF	Kerecis Omega3 Wound	2013-11-12
PMN K132343 | KGN KERECIS EHF	Alphaplex with MariGen Wound	2013-11-12