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HLB CO., LTD

US

Last updated May 30, 2026

What HLB CO., LTD makes

HLB Co., Ltd manufactures single-use blood lancets and manual blood lancing devices designed for repeated skin punctures, including sterile disposable models like the Eol Lancet Plus and SureComfort Safety Lancet. They also produce components for fully-implantable middle ear implant systems, specifically vibrator assemblies intended for cochlear or hearing aid applications. The company’s blood lancets are intended for medical and home monitoring use, while the implant components are part of surgical hearing restoration devices.

The company’s blood lancets and manual lancing devices are classified as Class II medical devices under FDA regulations and are listed in the FDA’s Unique Device Identifier (UDI) database. The vibrator assemblies for implantable middle ear systems fall under the same Class II designation. HLB Co., Ltd operates from the United States, adhering to applicable FDA requirements for device authorisation and traceability.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Information

Country
US
Address
—
Website
hlbbio.co.kr
LinkedIn
—
Facebook
—
Phone
+82448629134
PRRC Contact
—
EUDAMED SRN
—
FDA FEI Number
—
DUNS Number
987587913

Catalogue (13)

DeviceModel / ReferenceRegistriesClassStatus
Sterilized Eol Lancet Plus HCG LANCET 28G
FDA UDI
Class IIActive
SureComfort Safety Lancet LBAL 30G
FDA UDI
Class IIActive
Sterilized Eol Auto Lancet LBAL 26G
FDA UDI
Class IIActive
Sterilized Eol Lancet Plus HCG LANCET 30G
FDA UDI
Class IIActive
Sterilized Eol Auto Lancet LBAL 28G
FDA UDI
Class IIActive
Sterilized Eol Lancet Plus HCG LANCET 30G
FDA UDI
Class IIActive
Sterilized Eol Lancet Plus HCG LANCET 30G
FDA UDI
Class IIActive
Sterilized Eol Lancet Plus HCG LANCET 28G
FDA UDI
Class IIActive
Sterilized Eol Auto Lancet LBAL 30G
FDA UDI
Class IIActive
Sterilized Eol Lancet Plus HCG LANCET 26G
FDA UDI
Class IIActive
Sterilized Eol Lancet Plus HCG LANCET 26G
FDA UDI
Class IIActive
Sterilized Eol Lancet Plus HCG LANCET 28G
FDA UDI
Class IIActive
Sterilized Eol Lancet Plus HCG LANCET 26G
FDA UDI
Class IIActive

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