Sanquin Reagents B V

FDA Filings

This page includes the latest FDA filings for Sanquin Reagents B V. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

• Registration Number: 3014271897
• FEI Number: 3014271897
• Name: Ronald Eisenwinter
• Owner & Operator: Sanquin Reagents B.V.
• Contact Address: Plesmanlaan125 ; Amsterdam NL-NH Noord-Holland 1066CX NL
• Official Correspondent:
  • Anky Koenderman
  • 31-20-5123599-x
• US Agent:
  • Ronald Eisenwinter
  • 617 9642962
  • roneisen@rcn.com
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 221 Walnut Street #1 ; Newton, MA 02460 US
• Establishment Type: Manufacture Medical Device for Another Party (Contract Manufacturer)

FDA Filings

Device Company	Device	Date
PMN K171742 | DFH Ronald Eisenwinter [Sanquin Reagents B.V.]	N Latex FLC lambda	2018-01-16
PMN K171742 | DFH Ronald Eisenwinter [Sanquin Reagents B.V.]	N Latex FLC kappa	2018-01-16
PMN K171742 | DFH Ronald Eisenwinter [Sanquin Reagents B.V.]	N FLC Supplementary Reagent	2018-01-16
PMN K171742 | DFH Ronald Eisenwinter [Sanquin Reagents B.V.]	N FLC Standard SL	2018-01-16
PMN K171742 | DFH Ronald Eisenwinter [Sanquin Reagents B.V.]	N FLC Control SL2	2018-01-16
PMN K171742 | DFH Ronald Eisenwinter [Sanquin Reagents B.V.]	N FLC Control SL1	2018-01-16
PMN K171742 | DEH Ronald Eisenwinter [Sanquin Reagents B.V.]	N Latex FLC lambda	2018-01-16
PMN K171742 | DEH Ronald Eisenwinter [Sanquin Reagents B.V.]	N Latex FLC kappa	2018-01-16
PMN K171742 | DEH Ronald Eisenwinter [Sanquin Reagents B.V.]	N FLC Supplementary Reagent	2018-01-16
PMN K171742 | DEH Ronald Eisenwinter [Sanquin Reagents B.V.]	N FLC Standard SL	2018-01-16
PMN K171742 | DEH Ronald Eisenwinter [Sanquin Reagents B.V.]	N FLC Control SL2	2018-01-16
PMN K171742 | DEH Ronald Eisenwinter [Sanquin Reagents B.V.]	N FLC Control SL1	2018-01-16