Harvard Bioscience

FDA Filings

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

Harvard Bioscience holds import registrations or U.S. agent authorizations in conjunction with the following organizations:

• BIOCHROM LTD

FDA Registration(s)

• Registration Number: 3003521949
• FEI Number: 3003521949
• Name: BIOCHROM LTD
• Owner & Operator: Harvard Bioscience
• Contact Address: 84 OCTOBER HILL ROAD --; Holliston MA 01746 US
• Official Correspondent:
  • Nyerngoor Korda Hewitt
  • 1-508-8933125-x
• US Agent:
  • Jean D'Alessandro
  • HARVARD BIOSCIENCE
  • 508 8933125
  • jdalessandro@harvardbioscience.com
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 1020 CAMBOURNE BUSINESS PARK CAMBOURNE; CAMBRIDGE Cambridgeshire, CB23 6DW GB
• Establishment Type:
  • Complaint File Establishment per 21 CFR 820.198
  • Manufacture Medical Device

• Registration Number: 3008382976
• FEI Number: 3008382976
• Name: Biochrom US
• Owner & Operator: Harvard Bioscience
• Contact Address: 84 OCTOBER HILL ROAD --; Holliston MA 01746 US
• Official Correspondent:
  • Nyerngoor Korda Hewitt
  • 1-508-8933125-x
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 84 October Hill Rd Ste 10 ; Holliston, MA 01746 US
• Establishment Type: Manufacture Medical Device for Another Party (Contract Manufacturer)

FDA Filings

Device Company	Device	Date
JJF Biochrom US [Harvard Bioscience]	Bio30+	2008-01-04
JJF BIOCHROM LTD [Harvard Bioscience]	Bio30+	2008-01-04