Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3012502601

FEI Number

3012502601

Entity Name

HI MEDICAL CO., LTD.

City/State/Country

SEOUL, KR

Establishment Address

B-2005, 583, YANGCHEON-RO , GANGSEO-GU,, SEOUL 07547, KR

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device

Owner / Operator

HI MEDICAL CO., LTD. (Owner Number: 10052106)

Owner / Operator Contact Address

B-2005, 583, YANGCHEON-RO , GANGSEO-GU,, SEOUL, KR-11 07547, KR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K991088

PMA Number

N/A

All Registered Proprietary Names

BD VACUTAINER TRACE ELEMENT SERUM PLUS TUBE AND BD VACUTAINER TRACE ELEMENT K2EDTA PLUS TUBE GC 3M Nexcare 3M ESPE 3M Nexcare Dentsply 3M ESPE BD BD Microtainer MAP Microtube for Automated Process Denstply 3M Dentsply 3M ESPE Convatec BD Kulzer Convatec 3M ESPE Convatec Leukotape, Cover-roll, Haypafix GC Convatec 3M ESPE Convatec Convatec GC Convatec BD

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
JKA	Tubes, Vials, Systems, Serum Separators, Blood Collection	Clinical Chemistry	Class 2	862.1675	2021-04-25
EMA	Cement, Dental	Dental	Class 2	872.3275	2017-12-21
HOY	Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)	Ophthalmic	Class 1	886.4750	2018-02-20
EMA	Cement, Dental	Dental	Class 2	872.3275	2020-11-19
KGX	Tape And Bandage, Adhesive	General Hospital	Class 1	880.5240	2023-05-22
EGZ	Holder, Film, X-Ray	Dental	Class 1	872.1905	2026-06-03
KLE	Agent, Tooth Bonding, Resin	Dental	Class 2	872.3200	2026-02-10
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2020-03-11
JKA	Tubes, Vials, Systems, Serum Separators, Blood Collection	Clinical Chemistry	Class 2	862.1675	2021-04-25
NDP	Accessories, Implant, Dental, Endosseous	Dental	Class 1	872.3980	2023-08-15
KGX	Tape And Bandage, Adhesive	General Hospital	Class 1	880.5240	2016-06-22
EJK	Liner, Cavity, Calcium Hydroxide	Dental	Class 2	872.3250	2017-12-03
EZR	Cement, Stomal Appliance, Ostomy	Gastroenterology, Urology	Class 1	876.5900	2020-04-22
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2020-04-03
BSP	Needle, Conduction, Anesthetic (W/Wo Introducer)	Anesthesiology	Class 2	868.5150	2020-11-24
LOD	Bone Cement	Orthopedic	Class 2	888.3027	2021-06-02
NAE	Dressing, Wound, Hydrogel Without Drug And/Or Biologic	General, Plastic Surgery	Class 1	878.4022	2019-04-01
ELW	Material, Impression	Dental	Class 2	872.3660	2020-11-19
MGP	Dressing, Wound And Burn, Occlusive	Unknown	Class U	N/A	2020-03-24
KGX	Tape And Bandage, Adhesive	General Hospital	Class 1	880.5240	2020-02-18
EID	Syringe, Restorative And Impression Material	Dental	Class 1	872.4565	2018-04-03
NAD	Dressing, Wound, Occlusive	General, Plastic Surgery	Class 1	878.4020	2017-03-10
ELW	Material, Impression	Dental	Class 2	872.3660	2021-04-26
NAC	Dressing, Wound, Hydrophilic	General, Plastic Surgery	Class 1	878.4018	2017-10-11
EXD	Irrigator, Ostomy	Gastroenterology, Urology	Class 2	876.5895	2019-09-05
EMA	Cement, Dental	Dental	Class 2	872.3275	2020-11-19
EXE	Protector, Ostomy	Gastroenterology, Urology	Class 1	876.5900	2019-04-09
JKA	Tubes, Vials, Systems, Serum Separators, Blood Collection	Clinical Chemistry	Class 2	862.1675	2019-04-14

Official Correspondent

SEONG IL CHOI

US Agent Details

MYEONG HO HA Business: SKY EAGLE LOGISTICS, INC. Email: tiger1@skyeaglelogis.com Phone: (310) 8633700

Related Public Records

Same Entity

HI MEDICAL CO., LTD.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K945777	Smiths Industries Medical Systems, Inc.	PRO-VENT(TM), PULSATOR(R), AND LINE DRAW(TM) ARTERIAL BLOOD SAMPLING SYRINGES	1994-12-22
K972485	Arent, Fox, Kintner, Plotkin & Kahn	CIMPAT N	1997-09-08
K982895	Sterngold/Implamed	STERNOMEGA COMPOMER CEMENT	1998-10-09
K033068	Voco GmbH	IONOFIL COLOR AC	2003-10-31
K062064	Southern Dental Industries, Inc.	RIVA BOND LC	2006-11-09

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0030-2014	Perkin Elmer Health Sciences, Inc.	2	Perkin Elmer 226 Sample Collection Device, Serial numbers: 06132903 - 06198900. The PerkinElmer 226 Sample Collection Devices are intended to be used as a medium to collect and transport whole blood specimen spots to a laboratory, in newborn screening. The device includes a tear-apart form for the collection of demographic information.
Z-0035-2008	Heraeus Kulzer Inc., Dental Products Division	2	Heraeus Kulzer GLUMA Comfort Bond + Desensitizer light curing one component adhesive, contents: 4 ml, dental bonding agent. Distributed by Heraeus Kulzer, Inc., Armonk, NY; Reorder No. 66001710.
Z-0036-2008	Heraeus Kulzer Inc., Dental Products Division	2	Heraeus Kulzer GLUMA Comfort Bond + Desensitizer light curing one component adhesive, Assortment Value Pack 3 x 4 ml, dental bonding agent. Distributed by Heraeus Kulzer, Inc., Armonk, NY; Reorder No. 66018222.
Z-0002-2022	Bard Peripheral Vascular Inc	2	REF TIN3015, 15G x 79 mm Bone Marrow Aspiration/Intraosseous Infusion Needle, For Single Use Only, Sterile EO, UDI: 10885403043796
Z-0013-2022	Paltop Advanced Dental Solutions Ltd 5, Ha-Shita Caesarea Israel	1	Scan Abutment SP, Cat. No. 30-70101 - Product Usage: used to take an impression with an intra oral scanner or optical scanner to provide a digital registration of an implant or abutment platform. The Paltop Advanced Dental Solutions Implant System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient s chewing function.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3012502601. Last updated year: 2026. Please use registration number 3012502601 when referencing this establishment in official correspondence.