EU Manufacturer
๐ฐ๐ท South Korea
Active
The Standard. Co., Ltd.
SRN: KR-MF-000011647
ยท
Gunpocheomdansaneop 2-ro 120, 15880 Gunpo, South Korea
Basic UDI-DIs
4
Total Devices
4
On Market
4
Off Market
0
Certificates
2
Valid
0
Expiring < 6mo
0
Countries
6
Basic Information
- Address
- Gunpocheomdansaneop 2-ro 120, 15880 Gunpo, South Korea
- [email protected]
- Phone
- +82 2 838 5533
- Website
- https://www.thestandard.co.kr
Regulatory Overview
Regulation
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Eu Mdd
4
Classification
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Eu Md Class 2b
4
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Expired / Withdrawn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) | 81826199 | SGS Belgium NV | May 23, 2024 | |||
| MDD Annex II (excluding section 4) | KR19/81826199 | SGS Belgium NV | May 24, 2024 |
Market Presence
Devices from this manufacturer are available in 6 countries across Europe.
๐ฉ๐ช Germany
๐ช๐ธ Spain
๐ซ๐ฎ Finland
๐ซ๐ท France
๐ฎ๐น Italy
๐ณ๐ฑ Netherlands
Device Portfolio
| Name | ||||
|---|---|---|---|---|
| ASCENDO submucosal lifting agent | EU MDD | Eu Md Class 2b | On Market | 1 |
| Black Eye Endoscopic Marker Ink | EU MDD | Eu Md Class 2b | On Market | 1 |
| Blue Eye Submucosal Injection Agent | EU MDD | Eu Md Class 2b | On Market | 1 |
| Endoscopic Marker | EU MDD | Eu Md Class 2b | On Market | 1 |