EU Manufacturer
🇰🇷 South Korea
Active
CareforU.Co.Ltd
SRN: KR-MF-000031539
·
#405-2, Jeonpa-ro 88, Dongan-gu, Anyang city, 88, 13901 Anyang-si, South Korea
Basic UDI-DIs
6
Total Devices
6
On Market
6
Off Market
0
Certificates
1
Valid
0
Expiring < 6mo
0
Countries
0
Basic Information
- Address
- #405-2, Jeonpa-ro 88, Dongan-gu, Anyang city, 88, 13901 Anyang-si, South Korea
- [email protected]
- Phone
- +82805000016
- Website
- www.careforu.co.kr
Regulatory Overview
Regulation
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Eu Ivdd
4
Eu Ivdr
2
Classification
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Eu Ivd Class A
2
Eu Ivd General
2
Eu Ivd Self Testing
2
Device Types
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Certificate Health
Total
1
Valid
0
Expiring < 6mo
0
Expired / Withdrawn
1
Certificates by Expiry Year
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| Type | Number | Expiry Date | Status | |||
|---|---|---|---|---|---|---|
| IVDD Annex III Section 6 | 1434-IVDD-178/2022 | POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A. | May 27, 2025 |
Device Portfolio
| Name | ||||
|---|---|---|---|---|
| CareBuddy | EU IVDD | Eu Ivd Self Testing | On Market | 1 |
| CareBuddy | EU IVDD | Eu Ivd Self Testing | On Market | 1 |
| CareBuddy HbA1c | EU IVDD | Eu Ivd General | On Market | 0 |
| CareBuddy Multi | EU IVDR | Eu Ivd Class A | On Market | 0 |
| HUBI A1c | EU IVDD | Eu Ivd General | On Market | 0 |
| HUBI DIA | EU IVDR | Eu Ivd Class A | On Market | 0 |