Unicos Co L T D

FDA Filings

This page includes the latest FDA filings for Unicos Co L T D. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

• Registration Number: 3004167900
• FEI Number: 3004167900
• Name: UNICOS CO., LTD.
• Owner & Operator: UNICOS CO., LTD.
• Contact Address: 282-30, ,Munji-ro, Yuseong-gu, Jung-Gu; daejeon KR-30 Daejeon Gwangyeogsi 34050 KR
• Official Correspondent:
  • Sehyun Yu
  • 82-42-825-8046
• US Agent:
  • Gustavo Lancewicki
  • US Ophthalmic
  • 888 8811122
  • f.pazos@usophthalmic.com
• Importing Logistics Registration:
  • Importer: US OPHTHALMIC
  • Address: 9990 NW 14 Street unit 105 Doral, FL ; , Doral FL 33172
  • Email Address: UNITED STATES
  • Subdivision: Agent
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 282-30, Munji-ro, Yuseong-gu, ; daejeon Daejeon Gwangyeogsi, 34050 KR
• Establishment Type:
  • Manufacture Medical Device
  • Repack or Relabel Medical Device

FDA Filings

Device Company	Device	Date
HOX UNICOS CO., LTD.	ULC-900 Polirized	2020-01-30
HOX UNICOS CO., LTD.	ULC-900 Non-Polirized	2020-01-30
HOX UNICOS CO., LTD.	ULC-800 Polirized	2020-01-30
HOX UNICOS CO., LTD.	ULC-800 Non Polirized	2020-01-30
HLM UNICOS CO., LTD.	ULM-900	2015-08-31
HLM UNICOS CO., LTD.	ULM-800S	2015-08-31
HLM UNICOS CO., LTD.	ULM-800F	2015-08-31
HLM UNICOS CO., LTD.	UDL-800	2015-08-31
HLM UNICOS CO., LTD.	ELM-9200	2015-08-31
HLM UNICOS CO., LTD.	ELM-9000C	2015-08-31
HLM UNICOS CO., LTD.	ELM-9000A	2015-08-31
HLM UNICOS CO., LTD.	DLR-PLUS	2015-08-31
HOS UNICOS CO., LTD.	eCP-10	2009-06-01
HOS UNICOS CO., LTD.	ULC-900, Polarized	2009-06-01
HOS UNICOS CO., LTD.	ULC-900, Non-polarized	2009-06-01
HOS UNICOS CO., LTD.	ULC-800S, Polarized	2009-06-01
HOS UNICOS CO., LTD.	ULC-800S, Non-polarized	2009-06-01
HOS UNICOS CO., LTD.	ECP-9000LED	2009-06-01
HOS UNICOS CO., LTD.	ECP-9000	2009-06-01
HOS UNICOS CO., LTD.	ECP-7800LED	2009-06-01
HOS UNICOS CO., LTD.	ECP-5400	2009-06-01
HOS UNICOS CO., LTD.	ACP-900	2009-06-01
HOS UNICOS CO., LTD.	ACP-700	2009-06-01
HKO UNICOS CO., LTD.	eRK-10	2009-06-01
HKO UNICOS CO., LTD.	VISUREF 150	2009-06-01
HKO UNICOS CO., LTD.	VISUREF 100	2009-06-01
HKO UNICOS CO., LTD.	URK-900F	2009-06-01
HKO UNICOS CO., LTD.	URK-800F	2009-06-01
HKO UNICOS CO., LTD.	URK-800A	2009-06-01
HKO UNICOS CO., LTD.	URK-800	2009-06-01
HKO UNICOS CO., LTD.	URK-700A	2009-06-01
HKO UNICOS CO., LTD.	URK-700	2009-06-01
HKO UNICOS CO., LTD.	ERK-9200	2009-06-01
HKO UNICOS CO., LTD.	ERK-9000	2009-06-01
HKO UNICOS CO., LTD.	ERK-7800	2009-06-01
HKO UNICOS CO., LTD.	ERK-5400A	2009-06-01
HKO UNICOS CO., LTD.	ERK-5400	2009-06-01
HKN UNICOS CO., LTD.	eDR-10	2009-06-01
HKN UNICOS CO., LTD.	VDR-2400	2009-06-01
HKN UNICOS CO., LTD.	VDR-1900	2009-06-01
HKN UNICOS CO., LTD.	UDR-800	2009-06-01
HKN UNICOS CO., LTD.	UDR-700	2009-06-01
HKN UNICOS CO., LTD.	LDR-2600	2009-06-01
HKN UNICOS CO., LTD.	EDR-9000	2009-06-01
HKN UNICOS CO., LTD.	EDR-7800	2009-06-01
HKN UNICOS CO., LTD.	EDR-5400	2009-06-01

Related Finance Registrations

NCAGE Code	1X94F	UNICOS CO.,LTD
CAGE Code	1X94F	UNICOS CO.,LTD

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
202002047826	Pusan,South Korea -> Miami, Florida	LCD CHART	19 PKG
2020010720416	Pusan,South Korea -> New York/Newark Area, Newark, New Jersey	OPHTHALMIC INSTRUMENTS AND APPLIANCES	2 PKG
201912167425	Pusan,South Korea -> Miami, Florida	OPHTHALMIC INSTRUMENTS AND APPLIANCES	74 CTN
201910198645	Pusan,South Korea -> Miami, Florida	LCD CHART	10 PKG
2019082628235	Pusan,South Korea -> New York/Newark Area, Newark, New Jersey	AUTO REF KERATOMETER	3 PKG
2019062222406	Pusan,South Korea -> New York/Newark Area, Newark, New Jersey	AUTO REF KERATOMETER	1 PKG
201901144375	Pusan,South Korea -> Miami, Florida	LCD CHART	3 PKG
2018112466994	Pusan,South Korea -> Los Angeles, California	MUFFLER 8708.92	20 PKG