EU Manufacturer
๐ฐ๐ท South Korea
Active
Wellysis Corp.
SRN: KR-MF-000027374
ยท
8F, 425 Teheran-ro, Gangnam-gu, Seoul, 06159 Seoul, South Korea
Basic UDI-DIs
1
Total Devices
1
On Market
1
Off Market
0
Certificates
1
Valid
0
Expiring < 6mo
0
Countries
5
Basic Information
- Address
- 8F, 425 Teheran-ro, Gangnam-gu, Seoul, 06159 Seoul, South Korea
- [email protected]
Regulatory Overview
Regulation
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Eu Mdd
1
Classification
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Eu Md Class 2a
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Expired / Withdrawn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) | 0068/QCO-DM/165-2020 | MTIC InterCert S.r.l. | May 27, 2024 |
Market Presence
Devices from this manufacturer are available in 5 countries across Europe.
๐จ๐พ Cyprus
๐ฌ๐ท Greece
๐ช๐ธ Spain
๐ซ๐ท France
๐ฎ๐น Italy
Device Portfolio
| Name | ||||
|---|---|---|---|---|
| GENERAL PURPOSE ELECTROCARDIOGRAPHS | EU MDD | Eu Md Class 2a | On Market | 1 |