EU Manufacturer
๐ฐ๐ท South Korea
Active
CU Medical Systems, Inc.
SRN: KR-MF-000018333
ยท
Gwacheon-daero 12-gil, Gwacheon-si, Gyeonggi-do, Republic of Korea 117, 13824 Gwacheon, South Korea
Basic UDI-DIs
18
Total Devices
18
On Market
18
Off Market
0
Certificates
1
Valid
0
Expiring < 6mo
0
Countries
5
Basic Information
- Address
- Gwacheon-daero 12-gil, Gwacheon-si, Gyeonggi-do, Republic of Korea 117, 13824 Gwacheon, South Korea
- [email protected]
Regulatory Overview
Regulation
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Eu Mdd
18
Classification
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Eu Md Class 2b
18
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Expired / Withdrawn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) | 9805-2017-CE-KOR-NA-PS Rev. 6.0 | DNV Product Assurance AS | May 27, 2024 |
Market Presence
Devices from this manufacturer are available in 5 countries across Europe.
๐ฉ๐ช Germany
๐ช๐ธ Spain
๐ซ๐ท France
๐ฎ๐น Italy
๐ณ๐ฑ Netherlands
Device Portfolio
| Name | ||||
|---|---|---|---|---|
| EXTERNAL CARDIOVERSION DEFIBRILLATOR ELECTRODE PADS | EU MDD | Eu Md Class 2b | On Market | 1 |
| EXTERNAL CARDIOVERSION DEFIBRILLATOR ELECTRODE PADS | EU MDD | Eu Md Class 2b | On Market | 1 |
| EXTERNAL CARDIOVERSION DEFIBRILLATOR ELECTRODE PADS | EU MDD | Eu Md Class 2b | On Market | 1 |
| EXTERNAL CARDIOVERSION DEFIBRILLATOR ELECTRODE PADS | EU MDD | Eu Md Class 2b | On Market | 1 |
| EXTERNAL CARDIOVERSION DEFIBRILLATOR ELECTRODE PADS | EU MDD | Eu Md Class 2b | On Market | 1 |
| EXTERNAL CARDIOVERSION DEFIBRILLATOR ELECTRODE PADS | EU MDD | Eu Md Class 2b | On Market | 1 |
| EXTERNAL CARDIOVERSION DEFIBRILLATOR ELECTRODE PADS | EU MDD | Eu Md Class 2b | On Market | 1 |
| EXTERNAL CARDIOVERSION DEFIBRILLATOR ELECTRODE PADS | EU MDD | Eu Md Class 2b | On Market | 1 |
| EXTERNAL CARDIOVERSION DEFIBRILLATOR ELECTRODE PADS | EU MDD | Eu Md Class 2b | On Market | 1 |
| LiFEGAIN | EU MDD | Eu Md Class 2b | On Market | 1 |
| i-PAD | EU MDD | Eu Md Class 2b | On Market | 1 |
| i-PAD | EU MDD | Eu Md Class 2b | On Market | 1 |
| i-PAD | EU MDD | Eu Md Class 2b | On Market | 1 |
| i-PAD | EU MDD | Eu Md Class 2b | On Market | 1 |
| i-PAD | EU MDD | Eu Md Class 2b | On Market | 1 |
| i-PAD | EU MDD | Eu Md Class 2b | On Market | 1 |
| i-PAD | EU MDD | Eu Md Class 2b | On Market | 1 |
| i-PAD | EU MDD | Eu Md Class 2b | On Market | 1 |