EU Manufacturer
🇰🇷 South Korea
NEXTBIOMEDICAL CO., LTD.
SRN: KR-MF-000004808
·
6, Venture-ro 100beon-gil, Yeonsu-gu, 22013 Incheon, South Korea
Basic UDI-DIs
12
Total Devices
14
On Market
14
Off Market
0
Certificates
6
Valid
0
Expiring < 6mo
0
Countries
24
Basic Information
- Address
- 6, Venture-ro 100beon-gil, Yeonsu-gu, 22013 Incheon, South Korea
- [email protected]
- Phone
- +82 32 454 4800
- Website
- www.nextbiomedical.co.kr
Regulatory Overview
Regulation
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Eu Mdd
11
Eu Mdr
1
Classification
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Eu Md Class 3
9
Eu Md Class 1
1
Eu Md Class 2a
1
Eu Md Class 2b
1
Device Types
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Certificate Health
Total
6
Valid
0
Expiring < 6mo
0
Expired / Withdrawn
6
Certificates by Expiry Year
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| Type | Number | Expiry Date | Status | |||
|---|---|---|---|---|---|---|
| MDD Annex II (excluding section 4) | 2018-MDD/QS-032/C | 3EC International a.s. | Dec 04, 2023 | |||
| MDD Annex II Section 4 | 2018-MDD/DE-033/C | 3EC International a.s. | Dec 04, 2023 | |||
| MDD Annex II (excluding section 4) | 2018-MDD/QS-034C | 3EC International a.s. | Dec 04, 2023 | |||
| MDD Annex II (excluding section 4) | 2021-MDD/QS-052 | 3EC International a.s. | May 26, 2024 | |||
| MDD Annex II Section 4 | 2021-MDD/DE-053 | 3EC International a.s. | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | 2020-MDD/QS-037/A | 3EC International a.s. | May 26, 2024 |
Market Presence
Devices from this manufacturer are available in 24 countries across Europe.
🇦🇹 Austria
🇧🇪 Belgium
🇨🇿 Czechia
🇩🇪 Germany
🇩🇰 Denmark
🇪🇪 Estonia
🇬🇷 Greece
🇪🇸 Spain
🇫🇮 Finland
🇫🇷 France
🇭🇺 Hungary
🇮🇪 Ireland
🇮🇸 Iceland
🇮🇹 Italy
🇱🇹 Lithuania
🇱🇺 Luxembourg
🇱🇻 Latvia
🇳🇱 Netherlands
🇳🇴 Norway
🇵🇱 Poland
🇵🇹 Portugal
🇸🇪 Sweden
🇹🇷 Türkiye
🇬🇧 United Kingdom
Device Portfolio
| Name | ||||
|---|---|---|---|---|
| Nexpowder™ | EU MDD | Eu Md Class 3 | On Market | 2 |
| Nexpowder™ | EU MDD | Eu Md Class 3 | On Market | 2 |
| Nexpowder™ | EU MDD | Eu Md Class 3 | On Market | 1 |
| Nexpowder™ Catheter | EU MDD | Eu Md Class 2a | On Market | 1 |
| Nexpowder™ Hemostatic System for Endoscopy | EU MDR | Eu Md Class 2b | On Market | 0 |
| Nexpowder™ Hemostatic System for Endoscopy | EU MDR | Eu Md Class 2b | On Market | 0 |
| Nexpowder™ Hemostatic System for Endoscopy | EU MDR | Eu Md Class 2b | On Market | 0 |
| Nexsphere-F™ | EU MDD | Eu Md Class 3 | On Market | 2 |
| Nexsphere™ | EU MDD | Eu Md Class 3 | On Market | 1 |
| Nexsphere™ | EU MDD | Eu Md Class 3 | On Market | 1 |
| Nexsphere™ | EU MDD | Eu Md Class 3 | On Market | 1 |
| Nexsphere™ | EU MDD | Eu Md Class 3 | On Market | 1 |
| Nexsphere™ | EU MDD | Eu Md Class 3 | On Market | 1 |
| Spray Body | EU MDD | Eu Md Class 1 | On Market | 0 |