Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3030089798

FEI Number

3030089798

Entity Name

HLB LIFE SCIENCE CO., LTD.

City/State/Country

Anseong-si, Gyeonggi-do, KR

Establishment Address

122-39, Gieopdanji-ro, Gongdo-eup, Anseong-si, Gyeonggi-do 17551, KR

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

HLB Life Science Co., Ltd. (Owner Number: 10089317)

Owner / Operator Contact Address

122-39, Gieopdanji-ro, Gongdo-eup, Anseong-si, Gyeonggi-do, KR-NOTA 17551, KR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Membrane Filter Syringe/Sofjec, CarePoint Precision Single use Syringe with/without Needle/Sofjec, CarePoint Precision Single use Needle/Sofjec, CarePoint Precision Irrigation Syringe, Catheter Tip Syringe/Sofjec, CarePoint Precision

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2024-12-28
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2024-12-28
KYZ	Syringe, Irrigating (Non Dental)	General Hospital	Class 1	880.6960	2024-06-25

Official Correspondent

No official correspondent registered.

US Agent Details

Charles Mack Business: IRC USA Email: ircfda@gmail.com Phone: (931) 6254938

Related Public Records

Same Entity

HLB Life Science 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
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
K812404	Nu Tech Medical Systems	BUTTERFLY NEEDLE ASSEMBLY	1981-09-09

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0003-04	Liberty Medical Supplies	2	Liberty brand Insulin Syringes for use with U-100 insulin, 1/2 cc X 30G X 5/16'' syringes
Z-0004-04	Liberty Medical Supplies	2	Liberty brand Insulin Syringes for use with U-100 insulin, 1 cc X 29G X 1/2 '' insulin syringes
Z-0005-04	Liberty Medical Supplies	2	Liberty brand Insulin Syringes for use with U-100 insulin, 1/2 cc X 29G X 1/2 '' insulin syringes
Z-0005-2024	Fresenius Medical Care Holdings, Inc.	2	10ML SYRINGE LUER LOCK W/OUT NEEDLE, Part Number 15-R010-0, 100 per box, 12 boxes to a case
Z-0006-2024	Fresenius Medical Care Holdings, Inc.	2	10ML SYRINGE LUER LOCK W/NEEDLE, Part Number 15-10ML-0, 100 per box, 12 boxes per case

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3030089798. Last updated year: 2026. Please use registration number 3030089798 when referencing this establishment in official correspondence.