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 OFKOREA EXCHANGE (KOSDAQ)065510DUNS 688154202
FDA Registration(s)
Registration Number9616199
FEI Number3003768492
NameGustavo Lancewicki
Owner & OperatorHUVITZ CO., LTD.
Contact Address38, Burim-ro 170beon-gil Dongan-gu
Anyang-si KR-41 Gyeonggido 14055 KR
Official Correspondent
  • Hyung Min Heo
  • 82-31-4289100-9059
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address9990 NW 14th Street unit 105
Doral, FL 33172 US
Establishment TypeManufacture Medical Device



FDA Filings

Device
Company
DeviceDate
Huvitz Co., Ltd.
Optical Biometer HBM-1 2023-10-26
Huvitz Co., Ltd.
Auto Ref/Keratometer HRK-8100A 2023-09-01
Huvitz Co., Ltd.
Digital Refractor HDR-7100P 2023-09-01
Huvitz Co., Ltd.
Automated Perimetery HVF-100 HVF-1002023-06-20
Huvitz Co., Ltd.
Digital Refractor HDR-7000P HDR-7000P2023-06-20
Huvitz Co., Ltd.
Corneal Topographer HTG-1 HTG-12023-06-20
Huvitz Co., Ltd.
Digital Chart HDC-9100PF HDC-9100PF2023-06-20
Huvitz Co., Ltd.
Digital Chart HDC-9100N HDC-9100N2023-06-20
Huvitz Co., Ltd.
Auto Tono/Refracto/Kerato/Pachymeter HTR-1A HTR-1A2023-06-20
Huvitz Co., Ltd.
Ref-Keratometer ERK-9100 ERK-91002023-06-20
Huvitz Co., Ltd.
Non-contact Tonometer HNT-1P HNT-1P2023-06-20
Huvitz Co., Ltd.
Applanation Tonometer HT-5000 HT-50002023-06-20
Huvitz Co., Ltd.
Fundus Camera HFC-1 HFC-12021-02-17
Huvitz Co., Ltd.
Fundus Camera2021-02-02
Huvitz Co., Ltd.
Non-contact Tonometer HNT-1 HNT-12019-12-12
Huvitz Co., Ltd.
Digital Chart HDC-9000 HDC-90002019-07-22
Huvitz Co., Ltd.
Digital Chart HDC-7000 HDC-70002019-07-22
Huvitz Co., Ltd.
Huvitz Imaging System2019-07-18
Gustavo Lancewicki [HUVITZ CO., LTD.]
System, image management, ophthalmic2019-07-18
Huvitz Co., Ltd.
Auto Lensmeter HLM-7000 HLM-70002019-06-03
Huvitz Co., Ltd.
Optical Coherence Tomography HOCT-1F HOCT-1F2019-05-20
Huvitz Co., Ltd.
Ref-Keratometer HRK-1 HRK-12019-05-20
Huvitz Co., Ltd.
Optical Coherence Tomography HOCT-1 HOCT-12019-05-20
Huvitz Co., Ltd.
Auto Lensmeter HLM-7000P HLM-7000P 2019-05-20
Huvitz Co., Ltd.
Auto Lensmeter HLM-1 HLM-12019-05-20
Huvitz Co., Ltd.
Auto Lensmeter HLM-9000 HLM-90002019-05-20
Huvitz Co., Ltd.
Instrument Table CIT-4000 CIT-40002019-05-20
Huvitz Co., Ltd.
Opthalmic Table HRT-7000 HRT-70002019-05-20
Huvitz Co., Ltd.
Chart Projector HCP-7000 HCP-70002019-05-20
Huvitz Co., Ltd.
Chart Projector CCP-3100 CCP-31002019-05-20
Huvitz Co., Ltd.
Digital Refractor HDR-9000 HDR-90002019-05-20
Huvitz Co., Ltd.
Digital Refractor HDR-7000 HDR-70002019-05-20
Huvitz Co., Ltd.
Non-contact Tonometer HNT-7000 HNT-70002019-05-20
Huvitz Co., Ltd.
Auto Ref-Keratometer HRK-9000A HRK-9000A2019-05-20
Huvitz Co., Ltd.
Auto Ref-Keratometer HRK-8000A HRK-8000A2019-05-20
Huvitz Co., Ltd.
Auto Ref-Keratometer HRK-7000A HRK-7000A2019-05-20
Huvitz Co., Ltd.
Ref/Keratometers HRK-7000 HRK-70002019-05-20
Huvitz Co., Ltd.
maging System HIS-5000U HIS-5000U2019-05-20
Huvitz Co., Ltd.
Slit Lamp HS-7500 HS-7500(LED)2019-05-20
Huvitz Co., Ltd.
Slit Lamp HS-7500 HS-7500(HLG)2019-05-20
Huvitz Co., Ltd.
Slit Lamp HS-7000 HS-7000(HLG)2019-05-20
Huvitz Co., Ltd.
Non-contact Tonometer HNT-1 HNT-12019-05-20
Huvitz Co., Ltd.
Slit Lamp HS-5000 HS-50002019-05-17
Huvitz Co., Ltd.
Slit Lamp HS-5000 HS-50002019-05-17
Huvitz Co., Ltd.
Slit Lamp HS-7000 HS-70002019-05-17
Huvitz Co., Ltd.
Slit Lamp HS-5500 HS-5500(LED)2019-05-17
Huvitz Co., Ltd.
Slit Lamp HS-5000 HS-5000(LED)2019-05-17
Huvitz Co., Ltd.
Slit Lamp HS-5500 HS-5500(HLG)2019-05-17
Huvitz Co., Ltd.
Slit Lamp HS-5000 HS-50002019-05-17
Gustavo Lancewicki [HUVITZ CO., LTD.]
System, image management, ophthalmic2019-05-12
Gustavo Lancewicki [HUVITZ CO., LTD.]
Tomography, optical coherence2018-02-11
HUVITZ CO., LTD.
Huvitz Imaging System2017-04-06
Gustavo Lancewicki [HUVITZ CO., LTD.]
Tonometer, ac-powered2016-08-10
Gustavo Lancewicki [HUVITZ CO., LTD.]
Table, instrument, powered, ophthalmic2013-03-22
Gustavo Lancewicki [HUVITZ CO., LTD.]
Chart, visual acuity2011-12-15
Gustavo Lancewicki [HUVITZ CO., LTD.]
Biomicroscope, slit-lamp, ac-powered2010-03-11
HUVITZ CO., LTD.
SLIT LAMP, MODELS HS-5000, HS-5500 AND HS-75002009-12-03
Gustavo Lancewicki [HUVITZ CO., LTD.]
Biomicroscope, slit-lamp, ac-powered2008-01-20
HUVITZ CO., LTD.
SLIT LAMP2008-01-11
Gustavo Lancewicki [HUVITZ CO., LTD.]
Refractometer, ophthalmic2001-04-03
Gustavo Lancewicki [HUVITZ CO., LTD.]
Projector, ophthalmic2001-03-29
Gustavo Lancewicki [HUVITZ CO., LTD.]
Instrument, measuring, lens, ac-powered2001-03-29
Gustavo Lancewicki [HUVITZ CO., LTD.]
Refractor, manual, non-powered, including phoropter1999-10-14

Related Finance Registrations
U.S. Import Records [external site]
Import IDShipmentCargo DescriptionQuantity
2020083134374Pusan,South Korea -> New York/Newark Area, Newark, New JerseyAUTOMOTIVE PARTS71 CTN
202007132893Pusan,South Korea -> New York/Newark Area, Newark, New JerseyAUTOMOTIVE PARTS10 CTN
202007079984Pusan,South Korea -> New York/Newark Area, Newark, New JerseyAUTOMOTIVE PARTS10 CTN
2020070312374Pusan,South Korea -> New York/Newark Area, Newark, New JerseyAUTOMOTIVE PARTS10 CTN
2020070217284Pusan,South Korea -> New York/Newark Area, Newark, New JerseyAUTOMOTIVE PARTS10 CTN
2020062920920Pusan,South Korea -> New York/Newark Area, Newark, New JerseyAUTOMOTIVE PARTS10 CTN
202005041535Pusan,South Korea -> Miami, Florida(MACHINERY) OPHTHALMIC INSTRUMENTS AND APPLIA NCES LASER OPERATED INSTRUMENT229 CTN
2020042023854Pusan,South Korea -> New York/Newark Area, Newark, New JerseyAUTOMOTIVE PARTS52 CTN

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