Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010384323

FEI Number

3010384323

Entity Name

Medifirst Co.,Ltd.

City/State/Country

Cheonan-si, Chungnam, KR

Establishment Address

1049-16, Charyeonggogae-ro, Gwangdeok-myeon, Dongnam-gu,, Cheonan-si, Chungnam 330922, KR

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

MediFirst Co.,Ltd. (Owner Number: 10043739)

Owner / Operator Contact Address

1049-16, Charyeonggogae-ro,, Gwangdeok-myeon, Dongnam-gu,, Cheonan-si,, KR-44 330922, KR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K070917

PMA Number

N/A

All Registered Proprietary Names

Feel Fine Insulin pen needle ESR GRAPHENE MARATHON Face Mask/MF-KIP-007(L), MF-KIP-008(M), MF-KIP-009(S) RED SHIELD Face Mask(KF-AD)/MF-KFAD-001(L), MF-KFAD-002(M), MF-KFAD-003(S) RED SHIELD Face Mask(KF-80)/MF-KF80-001(L), MF-KF80-002(M), MF-KF80-003(S) RED SHIELD Face Mask(KF94)/MF-KF94-001(L), MF-KF94-002(M), MF-KF94-003(S) WOOA Face Mask(KF80)/MF-KF80-004(L), MF-KF80-005(M), MF-KF80-006(S) WOOA Face Mask(KF-AD)/MF-KFAD-004(L), MF-KFAD-005(M), MF-KFAD-006(S) MEDI HIT Face Mask/MF-KFAD-007(L), MF-KFAD-008(M), MF-KFAD-009(S) WOOA Face Mask(KF94)/MF-KF94-004(L), MF-KF94-005(M), MF-KF94-006(S) MEDI HIT Face Mask(KF94)/MF-KF94-007(L), MF-KF94-008(M), MF-KF94-009(S) MF SAFECATH MF Reagents (MF C001, MF C002, MF C003, MF C004, MF C005) Feel-Ject Insulin syringe

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2013-03-18
QKR	Face Mask Within The Scope Of The Face Mask And Barrier Face Covering Enforcement Policy Or Face Mask Umbrella Eua	Unknown	Class N	N/A	2020-09-17
FOZ	Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days	General Hospital	Class 2	880.5200	2020-05-18
KDT	Container, Specimen Mailer And Storage, Sterile	Pathology	Class 1	864.3250	2020-08-30
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2013-03-18

Official Correspondent

Young Ju Lee

US Agent Details

David Hyun Jun Paek Email: dpaek.rennes@gmail.com Phone: (818) 9030660

Related Public Records

Same Entity

MediFirst 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
K812404	Nu Tech Medical Systems	BUTTERFLY NEEDLE ASSEMBLY	1981-09-09
K943349	Quinton, Inc.	MAHURKAR DUAL LUMEN CATHETER	1995-03-22
K912158	Medical Device Inspection Co., Inc.	CENTRAL VENOUS CATHETER DRESSING CHANGE TRAY	1991-10-23
K880350	Honway International Co.	YUE/FA DISPOSABLE SYRINGE	1988-02-16
K003571	Terumo Medical Corp.	SERONO FOR USE WITH GONAL-F 1200IU MULTI-DOSE ONLY AT 600IU/ML SYRINGE	2001-02-12

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
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-0002-2024	ARROW INTERNATIONAL Inc.	2	Arrow ErgoPack Complete, Pressure Injectable Arrowg+ard Blue Plus Four-Lumen CVC, REF CDC-42854- PCN1A; catheter, intravascular, therapeutic, long-term greater than 30 days
Z-0003-2024	ARROW INTERNATIONAL Inc.	2	Arrow Pressure Injectable Arrowg+ard Blue Plus Four-Lumen CVC, REF CDC-45854-P1A; catheter, intravascular, therapeutic, long-term greater than 30 days
Z-0009-2023	B Braun Medical Inc	2	Introcan Safety FEP 14G, 2.2x32MM-US, Product Code 4251890-02. A passive anti-needle device to provide venous or arterial access.
Z-0025-2024	Becton Dickinson Infusion Therapy Systems Inc.	2	REF: 386862, BD Cathena Safety IV catheter with BD Multiguard Technology, 20 GA 1.00 IN, 1.1 x 25 mm 64 mL/min , Rx Only, Sterile EO

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010384323. Last updated year: 2026. Please use registration number 3010384323 when referencing this establishment in official correspondence.