EU Manufacturer
๐ฐ๐ท South Korea
Active
Dalim Tissen Co., Ltd.
SRN: KR-MF-000020019
ยท
Yeonhui-ro, Mapo-gu 31 , 03982 Seoul, South Korea
Basic UDI-DIs
37
Total Devices
87
On Market
87
Off Market
0
Certificates
7
Valid
0
Expiring < 6mo
0
Countries
14
Basic Information
- Address
- Yeonhui-ro, Mapo-gu 31 , 03982 Seoul, South Korea
- [email protected]
- Phone
- +82 2 3142 0846
- Website
- www.dalimtissen.com
Regulatory Overview
Regulation
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Eu Mdd
35
Eu Mdr
2
Classification
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Eu Md Class 3
37
Device Types
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Certificate Health
Total
7
Valid
0
Expiring < 6mo
0
Expired / Withdrawn
0
Certificates by Expiry Year
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| Type | Number | Expiry Date | Status | |||
|---|---|---|---|---|---|---|
| MDD Annex II Section 4 | 2019-MDD/QS-088/A, 2019-MDD/DE-009/A | 3EC International a.s. | Dec 31, 2027 | |||
| MDD Annex II Section 4 | 2019-MDD/QS-006/A, 2019-MDD/DE-007/A | 3EC International a.s. | Dec 31, 2027 | |||
| MDD Annex II Section 4 | 2019-MDD/QS-006/A, 2019-MDD/DE-007/A | 3EC International a.s. | Dec 31, 2027 | |||
| MDD Annex II Section 4 | 1434-MDD-257/2020, 1434-MDD-258/2020 | POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A. | Dec 31, 2027 | |||
| MDD Annex II Section 4 | 1434-MDD-255/2020, 1434-MDD-256/2020 | POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A. | Dec 31, 2027 | |||
| MDR Technical Documentation | 2024-MDR/QS-055, 2024-MDR/TD-055 | 3EC International a.s. | โ | |||
| MDR Technical Documentation | 2024-MDR/QS-056, 2024-MDR/TD-056 | 3EC International a.s. | โ |
Market Presence
Devices from this manufacturer are available in 14 countries across Europe.
๐ง๐ช Belgium
๐ง๐ฌ Bulgaria
๐จ๐พ Cyprus
๐จ๐ฟ Czechia
๐ฉ๐ช Germany
๐ฌ๐ท Greece
๐ช๐ธ Spain
๐ซ๐ท France
๐ญ๐บ Hungary
๐ฎ๐น Italy
๐ฒ๐น Malta
๐ต๐ฑ Poland
๐ท๐ด Romania
๐น๐ท Tรผrkiye
Device Portfolio
| Name | ||||
|---|---|---|---|---|
| Diaderm Tape | EU MDR | Eu Md Class 3 | On Market | 1 |
| CollaStat | EU MDD | Eu Md Class 3 | On Market | 1 |
| CollaStat | EU MDD | Eu Md Class 3 | On Market | 1 |
| CollaStat | EU MDD | Eu Md Class 3 | On Market | 1 |
| CollaStat | EU MDD | Eu Md Class 3 | On Market | 1 |
| Collabarrier | EU MDD | Eu Md Class 3 | On Market | 1 |
| Collabarrier | EU MDD | Eu Md Class 3 | On Market | 1 |
| Collabarrier | EU MDD | Eu Md Class 3 | On Market | 1 |
| Collabarrier | EU MDD | Eu Md Class 3 | On Market | 1 |
| Collabarrier | EU MDD | Eu Md Class 3 | On Market | 1 |
| Collabarrier | EU MDD | Eu Md Class 3 | On Market | 1 |
| Collabarrier | EU MDD | Eu Md Class 3 | On Market | 1 |
| Collabarrier | EU MDD | Eu Md Class 3 | On Market | 1 |
| Collabarrier | EU MDD | Eu Md Class 3 | On Market | 1 |
| Collabarrier | EU MDD | Eu Md Class 3 | On Market | 1 |
| Collabarrier | EU MDD | Eu Md Class 3 | On Market | 1 |
| Collabarrier | EU MDD | Eu Md Class 3 | On Market | 1 |
| Diaderm M | EU MDR | Eu Md Class 3 | On Market | 1 |
| Diaderm M | EU MDR | Eu Md Class 3 | On Market | 1 |
| Diaderm M | EU MDR | Eu Md Class 3 | On Market | 1 |
| Diaderm M | EU MDR | Eu Md Class 3 | On Market | 1 |
| Diaderm M | EU MDR | Eu Md Class 3 | On Market | 1 |
| Diaderm M | EU MDR | Eu Md Class 3 | On Market | 1 |
| Diaderm M | EU MDR | Eu Md Class 3 | On Market | 1 |
| Diaderm M | EU MDR | Eu Md Class 3 | On Market | 1 |
| Diaderm M | EU MDR | Eu Md Class 3 | On Market | 1 |
| Diaderm M | EU MDD | Eu Md Class 3 | On Market | 1 |
| Diaderm M | EU MDR | Eu Md Class 3 | On Market | 1 |
| Diaderm Plug | EU MDR | Eu Md Class 3 | On Market | 1 |
| Diaderm Plug | EU MDR | Eu Md Class 3 | On Market | 1 |
| Diaderm Tape | EU MDR | Eu Md Class 3 | On Market | 1 |
| Diaderm Tape | EU MDR | Eu Md Class 3 | On Market | 1 |
| Diaderm Tape | EU MDR | Eu Md Class 3 | On Market | 1 |
| Diaderm Tape | EU MDR | Eu Md Class 3 | On Market | 1 |
| Diaderm Tape | EU MDR | Eu Md Class 3 | On Market | 1 |
| Diaderm Tape | EU MDR | Eu Md Class 3 | On Market | 1 |
| Diaderm Tape | EU MDR | Eu Md Class 3 | On Market | 1 |
| Diaderm Tape | EU MDR | Eu Md Class 3 | On Market | 1 |
| Diaderm Tape | EU MDR | Eu Md Class 3 | On Market | 1 |
| Diaderm Tape | EU MDD | Eu Md Class 3 | On Market | 1 |
| Rapi-Gide | EU MDR | Eu Md Class 3 | On Market | 1 |
| Rapi-Gide | EU MDR | Eu Md Class 3 | On Market | 1 |
| Rapi-Gide | EU MDR | Eu Md Class 3 | On Market | 1 |
| Rapi-Gide | EU MDR | Eu Md Class 3 | On Market | 1 |
| Rapi-Gide | EU MDR | Eu Md Class 3 | On Market | 1 |
| Rapi-Gide | EU MDR | Eu Md Class 3 | On Market | 1 |
| Rapi-Gide | EU MDD | Eu Md Class 3 | On Market | 1 |
| Rapi-Gide | EU MDD | Eu Md Class 3 | On Market | 1 |
| Rapi-Gide | EU MDD | Eu Md Class 3 | On Market | 1 |
| Rapi-Gide | EU MDD | Eu Md Class 3 | On Market | 1 |