EU Manufacturer
๐ฐ๐ท South Korea
Active
GC Medical Science Corporation
SRN: KR-MF-000015840
ยท
Mugeuk-ro 65beon-gil 26, 27632 Geumwang-eup, Eumseong-gun, Chungcheongbuk-do, South Korea
Basic UDI-DIs
11
Total Devices
11
On Market
11
Off Market
0
Certificates
1
Valid
0
Expiring < 6mo
0
Countries
32
Basic Information
- Address
- Mugeuk-ro 65beon-gil 26, 27632 Geumwang-eup, Eumseong-gun, Chungcheongbuk-do, South Korea
- [email protected]
- Phone
- +82-31-260-9553
Regulatory Overview
Regulation
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Eu Ivdd
11
Classification
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Eu Ivd General
9
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Expired / Withdrawn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 IV (excluding sections 4, 6) | V1 049753 0022 | TรV SรD Product Service GmbH | May 26, 2025 |
Market Presence
Devices from this manufacturer are available in 32 countries across Europe.
๐ฆ๐น Austria
๐ง๐ช Belgium
๐ง๐ฌ Bulgaria
๐จ๐พ Cyprus
๐จ๐ฟ Czechia
๐ฉ๐ช Germany
๐ฉ๐ฐ Denmark
๐ช๐ช Estonia
๐ฌ๐ท Greece
๐ช๐ธ Spain
๐ซ๐ฎ Finland
๐ซ๐ท France
๐ญ๐ท Croatia
๐ญ๐บ Hungary
๐ฎ๐ช Ireland
๐ฎ๐ธ Iceland
๐ฎ๐น Italy
๐ฑ๐ฎ Liechtenstein
๐ฑ๐น Lithuania
๐ฑ๐บ Luxembourg
๐ฑ๐ป Latvia
๐ฒ๐น Malta
๐ณ๐ฑ Netherlands
๐ณ๐ด Norway
๐ต๐ฑ Poland
๐ต๐น Portugal
๐ท๐ด Romania
๐ธ๐ช Sweden
๐ธ๐ฎ Slovenia
๐ธ๐ฐ Slovakia
๐น๐ท Tรผrkiye
๐ฌ๐ง United Kingdom
Device Portfolio
| Name | ||||
|---|---|---|---|---|
| CHEMISTRY INSTRUMENTS - OTHER | EU IVDD | Eu Ivd Self Testing | On Market | 1 |
| GREENCARE A1c Analyzer | EU IVDD | Eu Ivd General | On Market | 0 |
| GREENCARE A1c Hemoglobin A1c Test Kit | EU IVDD | Eu Ivd General | On Market | 0 |
| GREENCARE A1c Hemoglobin A1c Test Kit | EU IVDD | Eu Ivd General | On Market | 0 |
| MULTIPLE PARAMETER BLOOD TEST | EU IVDD | Eu Ivd Self Testing | On Market | 1 |
| PocketChem A1c Advanced | EU IVDD | Eu Ivd General | On Market | 0 |
| PocketChem A1c Advanced Hemoglobin A1c Test Kit | EU IVDD | Eu Ivd General | On Market | 0 |
| QDx A1c Advance | EU IVDD | Eu Ivd General | On Market | 0 |
| QDx A1c Advance Test kit | EU IVDD | Eu Ivd General | On Market | 0 |
| responsยฎ A1c Analyzer | EU IVDD | Eu Ivd General | On Market | 0 |
| responsยฎA1c Hemoglobin A1c Test Kit | EU IVDD | Eu Ivd General | On Market | 0 |