EU Manufacturer
🇰🇷 South Korea
Active
DxGen Corp.
SRN: KR-MF-000030876
·
Rm. 303-1, Rm. 510, 172 LS-ro, Gunpo-si,, 15807 Gyeonggi-do, South Korea
Basic UDI-DIs
2
Total Devices
2
On Market
2
Off Market
0
Certificates
1
Valid
0
Expiring < 6mo
0
Countries
0
Basic Information
- Address
- Rm. 303-1, Rm. 510, 172 LS-ro, Gunpo-si,, 15807 Gyeonggi-do, South Korea
- [email protected]
Regulatory Overview
Regulation
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Eu Ivdd
2
Classification
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Eu Ivd General
2
Device Types
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Certificate Health
Total
1
Valid
0
Expiring < 6mo
0
Expired / Withdrawn
0
Certificates by Expiry Year
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| Type | Number | Expiry Date | Status | |||
|---|---|---|---|---|---|---|
| IVDD Annex III Section 6 | 002533 0006 | TÜV SÜD Product Service GmbH | Mar 28, 2027 |
Device Portfolio
| Name | ||||
|---|---|---|---|---|
| AUTODXTM CRP Test | EU IVDD | Eu Ivd General | On Market | 1 |
| AUTODXTM U-Albumin Test | EU IVDD | Eu Ivd General | On Market | 1 |