Huvitz Co L T D

FDA Filings

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

KOREA REP OF

KOREA EXCHANGE (KOSDAQ)

065510

DUNS 688154202

FDA Registration(s)

• Registration Number: 9616199
• FEI Number: 3003768492
• Name: Gustavo Lancewicki
• Owner & Operator: HUVITZ CO., LTD.
• Contact Address: 38, Burim-ro 170beon-gil Dongan-gu; Anyang-si KR-41 Gyeonggido 14055 KR
• Official Correspondent:
  • Hyung Min Heo
  • 82-31-4289100-9059
• US Agent:
  • Gustavo Lancewicki
  • US Ophthalmic
  • 888 8811122
  • f.pazos@usophthalmic.com
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 9990 NW 14th Street unit 105; Doral, FL 33172 US
• Establishment Type: Manufacture Medical Device

FDA Filings

Device Company	Device	Date
GUDID 00880019600961 Huvitz Co., Ltd.	Lilivis SCAN OPTOMO Y4XXCL-24-00001	2024-12-04
GUDID 08800019600985 Huvitz Co., Ltd.	Instrument Table CIT-4200	2024-07-02
GUDID 08800019600978 Huvitz Co., Ltd.	Instrument Table CIT-4100	2024-07-02
GUDID 08800019600909 Huvitz Co., Ltd.	Lilivis CAD L-CAD LS-100	2024-06-04
GUDID 08800019600893 Huvitz Co., Ltd.	Lilivis Scan LS-100 LS-100	2024-06-04
GUDID 08800019600787 Huvitz Co., Ltd.	Optical Biometer HBM-1	2023-10-26
GUDID 08800019600923 Huvitz Co., Ltd.	Auto Ref/Keratometer HRK-8100A	2023-09-01
GUDID 08800019600916 Huvitz Co., Ltd.	Digital Refractor HDR-7100P	2023-09-01
GUDID 08800019600824 Huvitz Co., Ltd.	Automated Perimetery HVF-100 HVF-100	2023-06-20
GUDID 08800019600817 Huvitz Co., Ltd.	Digital Refractor HDR-7000P HDR-7000P	2023-06-20
GUDID 08800019600770 Huvitz Co., Ltd.	Corneal Topographer HTG-1 HTG-1	2023-06-20
GUDID 08800019600749 Huvitz Co., Ltd.	Digital Chart HDC-9100PF HDC-9100PF	2023-06-20
GUDID 08800019600732 Huvitz Co., Ltd.	Digital Chart HDC-9100N HDC-9100N	2023-06-20
GUDID 08800019600558 Huvitz Co., Ltd.	Auto Tono/Refracto/Kerato/Pachymeter HTR-1A HTR-1A	2023-06-20
GUDID 08800019600503 Huvitz Co., Ltd.	Ref-Keratometer ERK-9100 ERK-9100	2023-06-20
GUDID 08800019600435 Huvitz Co., Ltd.	Non-contact Tonometer HNT-1P HNT-1P	2023-06-20
GUDID 08800019600411 Huvitz Co., Ltd.	Applanation Tonometer HT-5000 HT-5000	2023-06-20
GUDID 08800019600541 Huvitz Co., Ltd.	Fundus Camera HFC-1 HFC-1	2021-02-17
PMN K202097 Huvitz Co., Ltd.	Fundus Camera	2021-02-02
GUDID 08800019600428 Huvitz Co., Ltd.	Non-contact Tonometer HNT-1 HNT-1	2019-12-12
GUDID 08800019600190 Huvitz Co., Ltd.	Digital Chart HDC-9000 HDC-9000	2019-07-22
GUDID 08800019600183 Huvitz Co., Ltd.	Digital Chart HDC-7000 HDC-7000	2019-07-22
PMN K191615 Huvitz Co., Ltd.	Huvitz Imaging System	2019-07-18
PMN K191615 | NFJ Gustavo Lancewicki [HUVITZ CO., LTD.]	System, image management, ophthalmic	2019-07-18
GUDID 08800019600398 Huvitz Co., Ltd.	Auto Lensmeter HLM-7000 HLM-7000	2019-06-03
GUDID 08800019600497 Huvitz Co., Ltd.	Optical Coherence Tomography HOCT-1F HOCT-1F	2019-05-20
GUDID 08800019600480 Huvitz Co., Ltd.	Ref-Keratometer HRK-1 HRK-1	2019-05-20
GUDID 08800019600473 Huvitz Co., Ltd.	Optical Coherence Tomography HOCT-1 HOCT-1	2019-05-20
GUDID 08800019600459 Huvitz Co., Ltd.	Auto Lensmeter HLM-7000P HLM-7000P	2019-05-20
GUDID 08800019600442 Huvitz Co., Ltd.	Auto Lensmeter HLM-1 HLM-1	2019-05-20
GUDID 08800019600404 Huvitz Co., Ltd.	Auto Lensmeter HLM-9000 HLM-9000	2019-05-20
GUDID 08800019600374 Huvitz Co., Ltd.	Instrument Table CIT-4000 CIT-4000	2019-05-20
GUDID 08800019600244 Huvitz Co., Ltd.	Opthalmic Table HRT-7000 HRT-7000	2019-05-20
GUDID 08800019600237 Huvitz Co., Ltd.	Chart Projector HCP-7000 HCP-7000	2019-05-20
GUDID 08800019600220 Huvitz Co., Ltd.	Chart Projector CCP-3100 CCP-3100	2019-05-20
GUDID 08800019600213 Huvitz Co., Ltd.	Digital Refractor HDR-9000 HDR-9000	2019-05-20
GUDID 08800019600206 Huvitz Co., Ltd.	Digital Refractor HDR-7000 HDR-7000	2019-05-20
GUDID 08800019600176 Huvitz Co., Ltd.	Non-contact Tonometer HNT-7000 HNT-7000	2019-05-20
GUDID 08800019600169 Huvitz Co., Ltd.	Auto Ref-Keratometer HRK-9000A HRK-9000A	2019-05-20
GUDID 08800019600152 Huvitz Co., Ltd.	Auto Ref-Keratometer HRK-8000A HRK-8000A	2019-05-20
GUDID 08800019600145 Huvitz Co., Ltd.	Auto Ref-Keratometer HRK-7000A HRK-7000A	2019-05-20
GUDID 08800019600138 Huvitz Co., Ltd.	Ref/Keratometers HRK-7000 HRK-7000	2019-05-20
GUDID 08800019600121 Huvitz Co., Ltd.	maging System HIS-5000U HIS-5000U	2019-05-20
GUDID 08800019600077 Huvitz Co., Ltd.	Slit Lamp HS-7500 HS-7500(LED)	2019-05-20
GUDID 08800019600039 Huvitz Co., Ltd.	Slit Lamp HS-7500 HS-7500(HLG)	2019-05-20
GUDID 08800019600022 Huvitz Co., Ltd.	Slit Lamp HS-7000 HS-7000(HLG)	2019-05-20
GUDID 00880001960042 Huvitz Co., Ltd.	Non-contact Tonometer HNT-1 HNT-1	2019-05-20
GUDID 08800019600114 Huvitz Co., Ltd.	Slit Lamp HS-5000 HS-5000	2019-05-17
GUDID 08800019600107 Huvitz Co., Ltd.	Slit Lamp HS-5000 HS-5000	2019-05-17
GUDID 08800019600060 Huvitz Co., Ltd.	Slit Lamp HS-7000 HS-7000	2019-05-17
GUDID 08800019600053 Huvitz Co., Ltd.	Slit Lamp HS-5500 HS-5500(LED)	2019-05-17
GUDID 08800019600046 Huvitz Co., Ltd.	Slit Lamp HS-5000 HS-5000(LED)	2019-05-17
GUDID 08800019600015 Huvitz Co., Ltd.	Slit Lamp HS-5500 HS-5500(HLG)	2019-05-17
GUDID 08800019600008 Huvitz Co., Ltd.	Slit Lamp HS-5000 HS-5000	2019-05-17
PMN K161829 | NFJ Gustavo Lancewicki [HUVITZ CO., LTD.]	System, image management, ophthalmic	2019-05-12
OBO Gustavo Lancewicki [HUVITZ CO., LTD.]	Tomography, optical coherence	2018-02-11
PMN K161829 HUVITZ CO., LTD.	Huvitz Imaging System	2017-04-06
HKX Gustavo Lancewicki [HUVITZ CO., LTD.]	Tonometer, ac-powered	2016-08-10
HRJ Gustavo Lancewicki [HUVITZ CO., LTD.]	Table, instrument, powered, ophthalmic	2013-03-22
HOX Gustavo Lancewicki [HUVITZ CO., LTD.]	Chart, visual acuity	2011-12-15
PMN K093639 | HJO Gustavo Lancewicki [HUVITZ CO., LTD.]	Biomicroscope, slit-lamp, ac-powered	2010-03-11
PMN K093639 HUVITZ CO., LTD.	SLIT LAMP, MODELS HS-5000, HS-5500 AND HS-7500	2009-12-03
PMN K073190 | HJO Gustavo Lancewicki [HUVITZ CO., LTD.]	Biomicroscope, slit-lamp, ac-powered	2008-01-20
PMN K073190 HUVITZ CO., LTD.	SLIT LAMP	2008-01-11
HKO Gustavo Lancewicki [HUVITZ CO., LTD.]	Refractometer, ophthalmic	2001-04-03
HOS Gustavo Lancewicki [HUVITZ CO., LTD.]	Projector, ophthalmic	2001-03-29
HLM Gustavo Lancewicki [HUVITZ CO., LTD.]	Instrument, measuring, lens, ac-powered	2001-03-29
HKN Gustavo Lancewicki [HUVITZ CO., LTD.]	Refractor, manual, non-powered, including phoropter	1999-10-14

Related Finance Registrations

NCAGE Code	1F06F	HUVITZ CO., LTD
CAGE Code	1F06F	HUVITZ CO., LTD

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
2020083134374	Pusan,South Korea -> New York/Newark Area, Newark, New Jersey	AUTOMOTIVE PARTS	71 CTN
202007132893	Pusan,South Korea -> New York/Newark Area, Newark, New Jersey	AUTOMOTIVE PARTS	10 CTN
202007079984	Pusan,South Korea -> New York/Newark Area, Newark, New Jersey	AUTOMOTIVE PARTS	10 CTN
2020070312374	Pusan,South Korea -> New York/Newark Area, Newark, New Jersey	AUTOMOTIVE PARTS	10 CTN
2020070217284	Pusan,South Korea -> New York/Newark Area, Newark, New Jersey	AUTOMOTIVE PARTS	10 CTN
2020062920920	Pusan,South Korea -> New York/Newark Area, Newark, New Jersey	AUTOMOTIVE PARTS	10 CTN
202005041535	Pusan,South Korea -> Miami, Florida	(MACHINERY) OPHTHALMIC INSTRUMENTS AND APPLIA NCES LASER OPERATED INSTRUMENT	229 CTN
2020042023854	Pusan,South Korea -> New York/Newark Area, Newark, New Jersey	AUTOMOTIVE PARTS	52 CTN