Skip to content

Hlb Lifescience Co., Ltd.

South Korea KR-MF-000031817 Last updated 22 Oct 2026

Devices
76
Registries
EUDAMED
FDA recalls
0

Catalogue76

Page 1 of 2

Showing 1-50 of 76

What Hlb Lifescience Co., Ltd. makes

Hlb Lifescience Co., Ltd. manufactures single-use medical devices, including disposable needles, syringes (with and without needles), and membrane filter syringes designed for clinical and procedural use.

These products are classified as Class II devices under FDA regulations and are listed in the FDA’s 510(k) registry. The company is based in the United States.

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

Frequently asked questions

What types of medical devices does Hlb Lifescience Co., Ltd. manufacture?

Hlb Lifescience Co., Ltd. specializes in single-use medical devices. Their portfolio includes disposable needles, syringes (both with and without needles), and membrane filter syringes. These products are designed for clinical and procedural applications, ensuring ease of use and compliance with single-patient-use standards.

Where is Hlb Lifescience Co., Ltd. based?

Hlb Lifescience Co., Ltd. is headquartered in the United States. This location supports their global distribution and regulatory compliance efforts, particularly for devices marketed in regions governed by FDA standards.

Which regulatory registries list Hlb Lifescience Co., Ltd.’s devices?

Hlb Lifescience Co., Ltd.’s devices are listed in the FDA’s 510(k) registry. This registry tracks Class II medical devices that have undergone the 510(k) premarket notification process, demonstrating their compliance with FDA requirements before commercial distribution.

How are Hlb Lifescience Co., Ltd.’s devices classified under FDA regulations?

Hlb Lifescience Co., Ltd.’s devices are classified as Class II under FDA regulations. This classification applies to products that pose moderate risk and require special controls—such as performance standards, post-market surveillance, or labeling requirements—to ensure their safety and effectiveness.

AI-generated from registry data and not verified by a human reviewer.

Information

Country
South Korea
Address
104, Yongmeorikeun-gil, Gongdo-eup, Anseong-si, Gyeonggi-do,, South Korea
Phone
+82 31 658 8460
PRRC contact
Sang-woo Nam
EUDAMED SRN
KR-MF-000031817