Hi Medical Co L T D

FDA Filings

This page includes the latest FDA filings for Hi Medical 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 Number3012502601
FEI Number3012502601
NameHI MEDICAL CO., LTD.
Owner & OperatorHI MEDICAL CO., LTD.
Contact AddressB-2005, 583, YANGCHEON-RO , GANGSEO-GU,
SEOUL KR-11 Seoul Teugbyeolsi 07547 KR
Official Correspondent
  • SEONG IL CHOI
  • 82-2-2093-3291
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration AddressB-2005, 583, YANGCHEON-RO , GANGSEO-GU,
SEOUL Seoul Teugbyeolsi, 07547 KR
Establishment TypeExport Device to the United States But Perform No Other Operation on Device



FDA Owner/Operator Registration


FDA Filings

Device
Company
DeviceDate
HI MEDICAL CO., LTD.
Convatec2020-04-03
HI MEDICAL CO., LTD.
Aquacel Foam2020-04-03
HI MEDICAL CO., LTD.
3M Dressing, Wound And Burn, Occlusive2020-03-24
HI MEDICAL CO., LTD.
Philips2020-03-24
HI MEDICAL CO., LTD.
BD2020-03-11
HI MEDICAL CO., LTD.
Novofine2020-03-11
HI MEDICAL CO., LTD.
3M ESPE2020-03-09
HI MEDICAL CO., LTD.
Smith&Nephew2020-02-18
HI MEDICAL CO., LTD.
Leukotape, Cover-roll, Haypafix2020-01-22
HI MEDICAL CO., LTD.
Surgical Clipper Blade2019-10-04
HI MEDICAL CO., LTD.
Irrigator, ostomy2019-09-05
HI MEDICAL CO., LTD.
Duoderm dressing2019-05-02
HI MEDICAL CO., LTD.
DUODERM DRESSING2019-05-02
HI MEDICAL CO., LTD.
Aquacel with Strengthening fiber2019-05-02
HI MEDICAL CO., LTD.
Aquacel Foam2019-05-02
HI MEDICAL CO., LTD.
VACUTAINER BRAND MULTIPLE SAMPLE LUER ADAPTER, BLOOD COLLECTION SETS AND SAFETY-LOK BLOOD COLLECTION2019-04-14
HI MEDICAL CO., LTD.
PROTECTOR, OSTOMY2019-04-09
HI MEDICAL CO., LTD.
Dressing, wound, drug2019-04-09
HI MEDICAL CO., LTD.
SUTURE2019-04-01
HI MEDICAL CO., LTD.
SUTURE2019-04-01
HI MEDICAL CO., LTD.
SUTURE2019-04-01
HI MEDICAL CO., LTD.
SUTURE2019-04-01
HI MEDICAL CO., LTD.
SUTURE2019-04-01
HI MEDICAL CO., LTD.
SUTURE2019-04-01
HI MEDICAL CO., LTD.
SUTURE2019-04-01
HI MEDICAL CO., LTD.
COLLECTOR, OSTOMY2019-03-28
HI MEDICAL CO., LTD.
SUTURE, ABSORBABLE, SYNTHETIC2018-07-24
HI MEDICAL CO., LTD.
Ethicon2018-07-24
HI MEDICAL CO., LTD.
Attest2018-05-22
HI MEDICAL CO., LTD.
Orthoptic Eye Patch2018-02-20
HI MEDICAL CO., LTD.
Foam Dressing2017-10-11
HI MEDICAL CO., LTD.
NO STING2017-09-19
HI MEDICAL CO., LTD.
BARRIER FILM, SPRAY2017-09-19
HI MEDICAL CO., LTD.
Stethoscope2017-07-27
HI MEDICAL CO., LTD.
Duoderm2017-03-10
HI MEDICAL CO., LTD.
Ascensia Breeze 22016-09-06
HI MEDICAL CO., LTD.
Ascensia Breeze 22016-09-06
HI MEDICAL CO., LTD.
Ascensia Breeze 22016-09-06

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U.S. Import Records [external site]
Import IDShipmentCargo DescriptionQuantity
2020041139724Istanbul,Turkey -> New York/Newark Area, Newark, New JerseyMEDICAL PRODUCTS5 CAS
2019091130075Valencia,Spain -> Miami, FloridaSAFETY PUSH BUTTON BLOOD ADAPTER1760 CAS
2019091041458Valencia,Spain -> Miami, FloridaSAFETY PUSH BUTTON BLOOD ADAPTER1760 CAS
2019082628413Pusan,South Korea -> New York/Newark Area, Newark, New JerseyMEDICAL SUPPLIES WOUND DRESSING51 CTN
2019073020779Port Swettenham,Malaysia -> New York/Newark Area, Newark, New Jersey3M LITTMAN STETHOSCOPE CLASSIC III3 PKG
2019073020785Port Swettenham,Malaysia -> New York/Newark Area, Newark, New JerseyCARDIO IV N BLUE CARDIO IV HUNT GREEN CARDIO IV PLUM CARDIO IV RASPBERRY3 PKG
2019072319600Port Swettenham,Malaysia -> New York/Newark Area, Newark, New Jersey3M 1626W TEGADERM TRANSPARENT DRESSING5 PKG
2019062537577Bremerhaven,Federal Republic of Germany -> New York/Newark Area, Newark, New JerseySPECIALIZED DRESSINGS HS CODE 3005902 PKG

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