Helena Biosciences Europe

FDA Filings

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

FDA Registration(s)

• Registration Number: 3009736003
• FEI Number: 3009736003
• Name: Helena Laboratories UK Ltd
• Owner & Operator: Helena Biosciences Europe
• Contact Address: Queensway South Team Valley Trading Estate; Gateshead GB-GAT Gateshead NE11 0SD GB
• Official Correspondent:
  • Carol J Sandercock
  • 44-191-5160554-220
• US Agent:
  • Justin Padia
  • Regulatory Affairs
  • 409 8423714 1275
  • JPadia@helena.com
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: Queensway South Team Valley Trading Estate; Gateshead Newcastle upon Tyne, NE11 0SD GB
• Establishment Type: Manufacture Medical Device

FDA Filings

Device Company	Device	Date
CEF Helena Laboratories UK Ltd [Helena Biosciences Europe]	V8 Urine Preparation Buffer SPE	2012-07-27
CEF Helena Laboratories UK Ltd [Helena Biosciences Europe]	V8 Urine Preparation Buffer SP6	2012-07-27
CEF Helena Laboratories UK Ltd [Helena Biosciences Europe]	V8 Urine Preparation Buffer SP6 Zoom	2012-07-27
CEF Helena Laboratories UK Ltd [Helena Biosciences Europe]	V8 Storage Buffer	2012-07-27
CEF Helena Laboratories UK Ltd [Helena Biosciences Europe]	V8 Serum Protein SPE Kit	2012-07-27
CEF Helena Laboratories UK Ltd [Helena Biosciences Europe]	V8 Serum Protein SPE Buffer (single)	2012-07-27
CEF Helena Laboratories UK Ltd [Helena Biosciences Europe]	V8 Serum Protein 6 Band Zoom Kit	2012-07-27
CEF Helena Laboratories UK Ltd [Helena Biosciences Europe]	V8 Serum Protein 6 Band Zoom Buffer (single)	2012-07-27
CEF Helena Laboratories UK Ltd [Helena Biosciences Europe]	V8 Serum Protein 6 Band Kit	2012-07-27
CEF Helena Laboratories UK Ltd [Helena Biosciences Europe]	V8 Serum Protein 6 Band Buffer (single)	2012-07-27
CEF Helena Laboratories UK Ltd [Helena Biosciences Europe]	V8 Maintenance Buffer	2012-07-27
PMN K111369 | CFF Helena Laboratories UK Ltd [Helena Biosciences Europe]	V8 Immunodisplacement Kit	2012-07-17