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Sign in to claim this brandCareforU.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
- Website
- www.careforu.co.kr
- —
- —
- [email protected]
- Phone
- +82805000016
- PRRC Contact
- Byung Hoon Kho
- EUDAMED SRN
- KR-MF-000031539
- FDA FEI Number
- —
- DUNS Number
- —
Catalogue (6)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| CareBuddy HbA1c | CDC1B02 | EUDAMED | IVD General | Active |
| CareBuddy | CGSB02 | EUDAMED | IVD devices for self-testing | Active |
| CareBuddy Multi | CFU-D1 | EUDAMED | Class A | Active |
| HUBI A1c | AHA1C-8010 | EUDAMED | IVD General | Active |
| CareBuddy | CGMB02 | EUDAMED | IVD devices for self-testing | Active |
| Hubi Dia | AHD-8001 | EUDAMED | Class A | Active |
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