Topcon Europe Medical B V

FDA Filings

This page includes the latest FDA filings for Topcon Europe Medical 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: 3007913339
• FEI Number: 3007913399
• Name: TOPCON EUROPE MEDICAL BV
• Owner & Operator: Topcon Europe Medical BV
• Contact Address: Essebaan 11 Capelle a/d IJssel; Capelle a/d IJssel NL-ZH Zuid-Holland 2908 LJ NL
• US Agent:
  • Ramya Sundaram
  • Topcon Medical Systems, Inc.
  • 201 5995125
  • 201 5995248
  • rsundaram@topcon.com
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: Essebaan 11 Capelle a/d IJssel; Capelle a/d IJssel Zuid-Holland, 2908 LJ NL
• Establishment Type: Export Device to the United States But Perform No Other Operation on Device

FDA Filings

Device Company	Device	Date
HJO TOPCON EUROPE MEDICAL BV	ALADDIN TMS	2016-06-30
HRJ TOPCON EUROPE MEDICAL BV	IC-1	2016-03-15
HMF TOPCON EUROPE MEDICAL BV	IS-600N	2016-03-15
HMF TOPCON EUROPE MEDICAL BV	IS-600III	2016-03-15
HMF TOPCON EUROPE MEDICAL BV	IS-1P	2016-03-15
HMF TOPCON EUROPE MEDICAL BV	IS-1D	2016-03-15
HMF TOPCON EUROPE MEDICAL BV	IS-1	2016-03-15
HMF TOPCON EUROPE MEDICAL BV	IS-100	2016-03-15
HME TOPCON EUROPE MEDICAL BV	OC-9	2016-03-15
HME TOPCON EUROPE MEDICAL BV	OC-8	2016-03-15
HME TOPCON EUROPE MEDICAL BV	OC-66	2016-03-15
HME TOPCON EUROPE MEDICAL BV	OC-63	2016-03-15
HME TOPCON EUROPE MEDICAL BV	OC-12	2016-03-15
HME TOPCON EUROPE MEDICAL BV	OC-10	2016-03-15
PMN K131567 | HJO TOPCON EUROPE MEDICAL BV	Aladdin TMS	2014-12-19
PMN K131567 | HJO TOPCON EUROPE MEDICAL BV	Aladdin HW3.0	2014-12-19
PMN K131567 | HJO TOPCON EUROPE MEDICAL BV	ALADDIN HW2.0	2014-12-19
HOX TOPCON EUROPE MEDICAL BV	CC-100XP	2012-04-20
HOX TOPCON EUROPE MEDICAL BV	CC-100	2012-04-20
HLQ TOPCON EUROPE MEDICAL BV	CA-800	2012-04-20
HLQ TOPCON EUROPE MEDICAL BV	CA-200F	2012-04-20
HKN TOPCON EUROPE MEDICAL BV	CV-TABLET	2012-04-20

Related Finance Registrations

NCAGE Code	AH955	TOPCON EUROPE MEDICAL BV
CAGE Code	AH955	TOPCON EUROPE MEDICAL BV TOPCON ITALIA TOPCON EUROPE B.V. MMEDICAL DIVISION

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
202008049117	Rotterdam,Netherlands -> New York/Newark Area, Newark, New Jersey	MEDICAL EQUIPMENT HS 9402900	9 PKG
2020070877560	Rotterdam,Netherlands -> New York/Newark Area, Newark, New Jersey	MEDICAL EQUIPMENT HS 9402900	9 PKG