EU Manufacturer
🇰🇷 South Korea
Active
BrainU Co.,Ltd.
SRN: KR-MF-000033438
·
Bundang-gu, Yatap-ro 105beon-gil 7, 13506 Seongnam-si, Gyeonggi-do, South Korea
Basic UDI-DIs
1
Total Devices
1
On Market
1
Off Market
0
Certificates
1
Valid
0
Expiring < 6mo
0
Countries
1
Basic Information
- Address
- Bundang-gu, Yatap-ro 105beon-gil 7, 13506 Seongnam-si, Gyeonggi-do, South Korea
- [email protected]
- Phone
- +82-31-707-1788
- Website
- www.brainu.co.kr
Regulatory Overview
Regulation
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Eu Mdd
1
Classification
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Eu Md Class 2b
1
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Expired / Withdrawn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 | |||
|---|---|---|---|---|---|---|
| MDD Annex II (excluding section 4) | 2021-MDD/QS-008 | 3EC International a.s. | May 26, 2024 |
Market Presence
Devices from this manufacturer are available in 1 country across Europe.
🇬🇷 Greece
Device Portfolio
| Name | ||||
|---|---|---|---|---|
| CAI Monitoring System | EU MDD | Eu Md Class 2b | On Market | 1 |