EU Manufacturer
🇰🇷 South Korea
SG Medical Inc.
SRN: KR-MF-000009362
·
Ogeum-ro 13-gil, 05548 Seoul, South Korea
Basic UDI-DIs
57
Total Devices
57
On Market
57
Off Market
0
Certificates
2
Valid
0
Expiring < 6mo
0
Countries
0
Basic Information
- Address
- Ogeum-ro 13-gil, 05548 Seoul, South Korea
- [email protected]
- Phone
- +82 2 2240 7044
- Website
- www.sgmedical.kr
Regulatory Overview
Regulation
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Eu Ivdd
39
Eu Mdd
18
Classification
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Eu Ivd General
38
Eu Md Class 1
18
Eu Ivd Self Testing
1
Device Types
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Certificate Health
Total
2
Valid
0
Expiring < 6mo
0
Expired / Withdrawn
2
Certificates by Expiry Year
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| Type | Number | Expiry Date | Status | |||
|---|---|---|---|---|---|---|
| MDD Annex II (excluding section 4) | 1434-MDD-205/2021 | POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A. | May 27, 2024 | |||
| IVDD Annex III Section 6 | 1434-IVDD-197/2022 | POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A. | May 27, 2025 |
Device Portfolio
| Name | ||||
|---|---|---|---|---|
| ALLTM Set | EU IVDD | Eu Ivd General | On Market | 0 |
| ALLTM Set | EU IVDD | Eu Ivd General | On Market | 0 |
| ALLTM Set | EU IVDD | Eu Ivd General | On Market | 0 |
| ALLTM Set | EU IVDD | Eu Ivd General | On Market | 0 |
| ALLTM Set | EU IVDD | Eu Ivd General | On Market | 0 |
| ALLTM Set | EU IVDD | Eu Ivd General | On Market | 0 |
| ALLTM Set | EU IVDD | Eu Ivd General | On Market | 0 |
| ALLTM Set | EU IVDD | Eu Ivd General | On Market | 0 |
| ALLTM Set | EU IVDD | Eu Ivd General | On Market | 0 |
| ALLTM Set | EU IVDD | Eu Ivd General | On Market | 0 |
| ALLTM Set | EU IVDD | Eu Ivd General | On Market | 0 |
| ALLTM Set | EU IVDD | Eu Ivd General | On Market | 0 |
| ALLTM Set | EU IVDD | Eu Ivd General | On Market | 0 |
| ALLTM Set | EU IVDD | Eu Ivd General | On Market | 0 |
| CORONAVIRUS [obsolete from 2025-01-01] | EU IVDD | Eu Ivd General | On Market | 0 |
| CORONAVIRUS [obsolete from 2025-01-01] | EU IVDD | Eu Ivd Self Testing | On Market | 1 |
| CORONAVIRUS [obsolete from 2025-01-01] | EU IVDD | Eu Ivd General | On Market | 0 |
| CORONAVIRUS [obsolete from 2025-01-01] | EU IVDD | Eu Ivd General | On Market | 0 |
| GeneTM Set | EU IVDD | Eu Ivd General | On Market | 0 |
| GeneTM Set | EU IVDD | Eu Ivd General | On Market | 0 |
| GeneTM Set | EU IVDD | Eu Ivd General | On Market | 0 |
| GeneTM Set | EU IVDD | Eu Ivd General | On Market | 0 |
| GeneTM Set | EU IVDD | Eu Ivd General | On Market | 0 |
| GeneTM Set | EU IVDD | Eu Ivd General | On Market | 0 |
| GeneTM Set | EU IVDD | Eu Ivd General | On Market | 0 |
| GeneTM Set | EU IVDD | Eu Ivd General | On Market | 0 |
| GeneTM Set | EU IVDD | Eu Ivd General | On Market | 0 |
| GeneTM Set | EU IVDD | Eu Ivd General | On Market | 0 |
| GeneTM Set | EU IVDD | Eu Ivd General | On Market | 0 |
| GeneTM Set | EU IVDD | Eu Ivd General | On Market | 0 |
| GeneTM Set | EU IVDD | Eu Ivd General | On Market | 0 |
| SELTM Set | EU IVDD | Eu Ivd General | On Market | 0 |
| SELTM Set | EU IVDD | Eu Ivd General | On Market | 0 |
| SG Brush | EU MDD | Eu Md Class 1 | On Market | 1 |
| SG Brush | EU MDD | Eu Md Class 1 | On Market | 1 |
| SG Brush | EU MDD | Eu Md Class 1 | On Market | 1 |
| SG Brush | EU MDD | Eu Md Class 1 | On Market | 1 |
| SG Brush | EU MDD | Eu Md Class 1 | On Market | 1 |
| SG Brush | EU MDD | Eu Md Class 1 | On Market | 1 |
| SG Brush | EU MDD | Eu Md Class 1 | On Market | 1 |
| SG Brush | EU MDD | Eu Md Class 1 | On Market | 1 |
| SG Brush | EU MDD | Eu Md Class 1 | On Market | 1 |
| SG Brush | EU MDD | Eu Md Class 1 | On Market | 1 |
| SG Brush | EU MDD | Eu Md Class 1 | On Market | 1 |
| SG Brush | EU MDD | Eu Md Class 1 | On Market | 1 |
| SG Brush | EU MDD | Eu Md Class 1 | On Market | 1 |
| SG Brush | EU MDD | Eu Md Class 1 | On Market | 1 |
| SG Brush | EU MDD | Eu Md Class 1 | On Market | 1 |
| SG Brush | EU MDD | Eu Md Class 1 | On Market | 1 |
| SG Brush | EU MDD | Eu Md Class 1 | On Market | 1 |