EU Manufacturer
🇰🇷 South Korea
Active
FCU Co., Ltd.
SRN: KR-MF-000015583
·
2F, 62-4, Techno 1-ro, 34014 Daejeon, 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
- 2F, 62-4, Techno 1-ro, 34014 Daejeon, South Korea
- [email protected]
- Phone
- +82 42 936 9078
- Website
- https://fcultrasound.com
Regulatory Overview
Regulation
Loading...
Eu Mdd
1
Classification
Loading...
Eu Md Class 2a
1
Device Types
Loading...
Certificate Health
Total
1
Valid
0
Expiring < 6mo
0
Expired / Withdrawn
1
Certificates by Expiry Year
Loading...
| Type | Number | Expiry Date | Status | |||
|---|---|---|---|---|---|---|
| MDD Annex II (excluding section 4) | 1434-MDD-365/2021 | POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A. | May 27, 2024 |
Market Presence
Devices from this manufacturer are available in 1 country across Europe.
🇩🇪 Germany
Device Portfolio
| Name | ||||
|---|---|---|---|---|
| Sonovation1L, SOFRA1L, SonoInfra1L, Dr.SAFE, ACUFRIEND, ACUGUIDE,ACUWARY, AcuViz Pocket, Sono Cloud 1, eZono1000, eZ1L | EU MDD | Eu Md Class 2a | On Market | 1 |