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CareforU.Co.Ltd

South Korea·KR-MF-000031539

Last updated September 17, 2026

About

Hepatitis B, Hepatitis B, Hepatitis B, Hepatitis B

Translated from the manufacturer's own website. Source

What CareforU.Co.Ltd makes

CareforU.Co.Ltd manufactures point-of-care diagnostic devices, including self-testing systems for blood glucose monitoring (CareBuddy and CareBuddy Multi) and HbA1c measurement (CareBuddy HbA1c and HUBI A1c). The company also produces diagnostic tools for hepatitis B testing (HUBI DIA).

These devices fall under Class A medical devices and IVD categories, including general IVDs and self-testing IVDs, and are listed in the EU’s eudamed registry. The company is based in South Korea.

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 CareforU.Co.Ltd manufacture?

CareforU.Co.Ltd produces point-of-care diagnostic devices, including self-testing systems for blood glucose monitoring (such as CareBuddy and CareBuddy Multi) and HbA1c measurement (like CareBuddy HbA1c and HUBI A1c). Additionally, the company develops diagnostic tools for hepatitis B testing, specifically the HUBI DIA device. These products are designed for easy use in home or clinical settings.

Where is CareforU.Co.Ltd based?

CareforU.Co.Ltd is headquartered in South Korea. The company’s location in South Korea supports its development and manufacturing of diagnostic devices, which are then distributed globally for use in managing chronic conditions like diabetes and infectious diseases.

Are CareforU.Co.Ltd’s devices listed in any regulatory registries?

Yes, CareforU.Co.Ltd’s devices are listed in the EU’s eudamed registry. This registry is used to track medical devices authorized for placement on the European market, ensuring transparency and traceability of products like their point-of-care diagnostics.

How are CareforU.Co.Ltd’s devices classified under medical device regulations?

CareforU.Co.Ltd’s devices fall under Class A medical device classifications and are categorized as In Vitro Diagnostic (IVD) devices. Some of their products, like self-testing systems, are specifically classified as IVD devices for self-testing, which are designed for use by individuals without professional medical supervision. IVD General classifications cover other diagnostic tools like the HUBI DIA for hepatitis B testing.

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

Information

Country
South Korea
Address
88, #405-2, Jeonpa-ro 88, Dongan-gu, Anyang city, , Anyang-si, South Korea
LinkedIn
—
Facebook
—
Phone
+82805000016
PRRC Contact
Byung Hoon Kho
EUDAMED SRN
KR-MF-000031539
FDA FEI Number
—
DUNS Number
—

Catalogue (6)

DeviceModel / ReferenceRegistriesClassStatus
CareBuddy HbA1c CDC1B02
EUDAMED
IVD GeneralActive
CareBuddy CGSB02
EUDAMED
IVD devices for self-testingActive
CareBuddy Multi CFU-D1
EUDAMED
Class AActive
HUBI A1c AHA1C-8010
EUDAMED
IVD GeneralActive
CareBuddy CGMB02
EUDAMED
IVD devices for self-testingActive
Hubi Dia AHD-8001
EUDAMED
Class AActive

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