EU Manufacturer
🇰🇷 South Korea
Active
GC MEDIS Corp.
SRN: KR-MF-000012638
·
Jeongja 1-gil, Seonggeo-eup, Seobuk-gu, Cheonan-si, 16, 31045 Chungcheongnam-do, South Korea
Basic UDI-DIs
31
Total Devices
31
On Market
31
Off Market
0
Certificates
3
Valid
0
Expiring < 6mo
0
Countries
4
Basic Information
- Address
- Jeongja 1-gil, Seonggeo-eup, Seobuk-gu, Cheonan-si, 16, 31045 Chungcheongnam-do, South Korea
- [email protected]
- Phone
- +82-31-267-8470
- Website
- http://www.gcmedis.com
Regulatory Overview
Regulation
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Eu Ivdd
30
Eu Ivdr
1
Classification
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Eu Ivd Annex 2 List B
13
Eu Ivd General
11
Eu Ivd Self Testing
6
Eu Ivd Class A
1
Device Types
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Certificate Health
Total
3
Valid
0
Expiring < 6mo
0
Expired / Withdrawn
3
Certificates by Expiry Year
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| Type | Number | Expiry Date | Status | |||
|---|---|---|---|---|---|---|
| IVDD Annex IV (excluding sections 4, 6) | V1 091763 0015 | TÜV SÜD Product Service GmbH | May 26, 2024 | |||
| IVDD Annex IV (excluding sections 4, 6) | V74 091763 0019 | TÜV SÜD Product Service GmbH | May 26, 2024 | |||
| IVDD Annex IV (excluding sections 4, 6) | Q5 091763 0014 | TÜV SÜD Product Service GmbH | Oct 13, 2025 |
Market Presence
Devices from this manufacturer are available in 4 countries across Europe.
🇧🇪 Belgium
🇨🇾 Cyprus
🇪🇸 Spain
🇱🇹 Lithuania
Device Portfolio
| Name | ||||
|---|---|---|---|---|
| CERA-CHEK™ 3 in 1 GHL Blood Glucose Test Strip | EU IVDD | Eu Ivd Annex 2 List B | On Market | 1 |
| CERA-CHEK™ 3 in 1 GHL Blood Glucose, Hemoglobin, Lactate Monitoring System | EU IVDD | Eu Ivd Annex 2 List B | On Market | 1 |
| CERA-CHEK™ 3 in 1 GHL Glucose Control Solution | EU IVDD | Eu Ivd Annex 2 List B | On Market | 1 |
| CERA-CHEK™ 3 in 1 GHL Hemoglobin Control Solution | EU IVDD | Eu Ivd Annex 2 List B | On Market | 1 |
| CERA-CHEK™ 3 in 1 GHL Hemoglobin Test Strip | EU IVDD | Eu Ivd Annex 2 List B | On Market | 1 |
| CERA-CHEK™ 3 in 1 GHL Lactate Control Solution | EU IVDD | Eu Ivd Annex 2 List B | On Market | 1 |
| CERA-CHEK™ 3 in 1 GHL Lactate Test Strip | EU IVDD | Eu Ivd Annex 2 List B | On Market | 1 |
| CERA-CHEK™ 1070 Blood Glucose Monitoring System | EU IVDD | Eu Ivd Annex 2 List B | On Market | 1 |
| CERA-CHEK™ 1070 Blood Glucose Test Strip | EU IVDD | Eu Ivd Annex 2 List B | On Market | 1 |
| CERA-CHEK™ 1070 Glucose Control Solution | EU IVDD | Eu Ivd Annex 2 List B | On Market | 1 |
| CERA-CHEK™ 1Code Blood Glucose Monitoring System | EU IVDD | Eu Ivd Annex 2 List B | On Market | 1 |
| CERA-CHEK™ 1Code Blood Glucose Test Strip | EU IVDD | Eu Ivd Annex 2 List B | On Market | 1 |
| CERA-CHEK™ 1Code Glucose Control Solution | EU IVDD | Eu Ivd Annex 2 List B | On Market | 1 |
| CERA-CHEK™ Hb Plus Hemoglobin Control Solution | EU IVDD | Eu Ivd Self Testing | On Market | 1 |
| CERA-CHEK™ Hb Plus Hemoglobin Measuring System | EU IVDD | Eu Ivd Self Testing | On Market | 1 |
| CERA-CHEK™ Hb Plus Hemoglobin Test Strip | EU IVDD | Eu Ivd Self Testing | On Market | 1 |
| CERA-CHEK™ Lactate Control Solution | EU IVDD | Eu Ivd Self Testing | On Market | 1 |
| CERA-CHEK™ Lactate Measuring System | EU IVDD | Eu Ivd Self Testing | On Market | 1 |
| CERA-CHEK™ Lactate Test Strip | EU IVDD | Eu Ivd Self Testing | On Market | 1 |
| CERA-STAT™ 2000 Analyzer | EU IVDD | Eu Ivd General | On Market | 0 |
| CERA-STAT™ 2000 HbA1c Control Solution | EU IVDD | Eu Ivd General | On Market | 1 |
| CERA-STAT™ 2000 HbA1c Test Kit | EU IVDD | Eu Ivd General | On Market | 0 |
| CERA-STAT™ 4000 Analyzer | EU IVDD | Eu Ivd General | On Market | 0 |
| CERA-STAT™ 4000 Analyzer | EU IVDR | Eu Ivd Class A | On Market | 0 |
| CERA-STAT™ CRP Control Solution | EU IVDD | Eu Ivd General | On Market | 0 |
| CERA-STAT™ CRP Test Kit | EU IVDD | Eu Ivd General | On Market | 0 |
| CERA-STAT™ HbA1c Control Solution | EU IVDD | Eu Ivd General | On Market | 0 |
| CERA-STAT™ HbA1c Test Kit | EU IVDD | Eu Ivd General | On Market | 0 |
| LabonaCheck™ A1c Control Solution | EU IVDD | Eu Ivd General | On Market | 1 |
| LabonaCheck™ A1c HbA1c Analyzer | EU IVDD | Eu Ivd General | On Market | 0 |
| LabonaCheck™ A1c HbA1c Test Kit | EU IVDD | Eu Ivd General | On Market | 0 |