Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3016748351

FEI Number

3016748351

Entity Name

HLB Life Science CO., LTD

City/State/Country

Anseong-si Gyeonggi, KR

Establishment Address

104, Yongmeorikeun-gil, Gongdo-eup, Anseong-si Gyeonggi 17551, KR

Establishment Type(s)

Manufacture Medical Device,Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

HLB Life Science CO., LTD (Owner Number: 10079867)

Owner / Operator Contact Address

104, Yongmeorikeun-gil, Gongdo-eup, Anseong-si, Gyeonggi-do, Republic of Korea, Anseong-si, KR-41 17551, KR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Inverted cup 61mm 10ul Capillary tube 5ul Capillary tube Mini-tip 20ul (non-heparin) Mini-tip QP type 10ul (with plunger) Mini-tip R type 10ul (with silicone plunger) Mini-tip QP type 20ul (with plunger) Capillary tube 10, 20ul (10ul Blue, 20ul Black, 2 line) Mini-tip Q type 10ul (without plunger) Mini-tip R type 20ul (with silicone plunger) Mini-tip Q type 20ul (without plunger) 20ul Capillary tube Mini-tip 10ul (non-heparin) Inverted cup 80mm Mini-tip R type 50ul (with silicone plunger) Easy Sample Collector Hydrophili Capillary tube 5ul, 10ul(Black, 2 line) AIM Foam swab AIM Nasal Swab AIM Collection Swab AIM Swab Set(AIM Nasal Swab+AIM Foam Swab)

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GIO	Tube, Collection, Capillary Blood	Hematology	Class 1	864.6150	2020-12-29
KXG	Applicator, Absorbent Tipped, Sterile	General Hospital	Class 1	880.6025	2021-03-26

Official Correspondent

No official correspondent registered.

US Agent Details

Jongoh CHOO Business: SMGUSA LLC Email: ce@smgusa.org Phone: (307) 6502347

Related Public Records

Same Entity

HLB Life Science CO., LTD

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

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3016748351. Last updated year: 2026. Please use registration number 3016748351 when referencing this establishment in official correspondence.