EU Manufacturer
🇸🇪 Sweden
Active
Nidacon International AB
SRN: SE-MF-000001933
·
Flöjelbergsgatan 16B, 43137 Mölndal, Sweden
Basic UDI-DIs
15
Total Devices
15
On Market
15
Off Market
0
Certificates
4
Valid
0
Expiring < 6mo
0
Countries
32
Basic Information
- Address
- Flöjelbergsgatan 16B, 43137 Mölndal, Sweden
- [email protected]
- Phone
- +46 31 7030630
- Website
- www.nidacon.com
Regulatory Overview
Regulation
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Eu Mdd
15
Classification
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Eu Md Class 3
14
Eu Md Class 2a
1
Device Types
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Certificate Health
Total
4
Valid
0
Expiring < 6mo
0
Expired / Withdrawn
4
Certificates by Expiry Year
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| Type | Number | Expiry Date | Status | |||
|---|---|---|---|---|---|---|
| MDD Annex II (excluding section 4) | 241568-2017-CE-NOR-NA-P | DNV Product Assurance AS | Nov 20, 2000 | |||
| MDD Annex II Section 4 | 241555-2017-CE-NOR-NA-PS | DNV Product Assurance AS | Feb 07, 2022 | |||
| MDD Annex II Section 4 | 241564-2017-CE-NOR-NA-PS | DNV Product Assurance AS | Feb 07, 2022 | |||
| MDD Annex II (excluding section 4) | 241568-2017-CE-NOR-NA-PS | DNV Product Assurance AS | Dec 17, 2022 |
Market Presence
Devices from this manufacturer are available in 32 countries across Europe.
🇦🇹 Austria
🇧🇪 Belgium
🇧🇬 Bulgaria
🇨🇾 Cyprus
🇨🇿 Czechia
🇩🇪 Germany
🇩🇰 Denmark
🇪🇪 Estonia
🇬🇷 Greece
🇪🇸 Spain
🇫🇮 Finland
🇫🇷 France
🇭🇷 Croatia
🇭🇺 Hungary
🇮🇪 Ireland
🇮🇸 Iceland
🇮🇹 Italy
🇱🇮 Liechtenstein
🇱🇹 Lithuania
🇱🇺 Luxembourg
🇱🇻 Latvia
🇲🇹 Malta
🇳🇱 Netherlands
🇳🇴 Norway
🇵🇱 Poland
🇵🇹 Portugal
🇷🇴 Romania
🇸🇪 Sweden
🇸🇮 Slovenia
🇸🇰 Slovakia
🇹🇷 Türkiye
🇬🇧 United Kingdom
Device Portfolio
| Name | ||||
|---|---|---|---|---|
| NidOil | EU MDD | Eu Md Class 3 | On Market | 1 |
| NidOil | EU MDD | Eu Md Class 3 | On Market | 1 |
| ProInsert | EU MDD | Eu Md Class 2a | On Market | 1 |
| PureSperm 100 | EU MDD | Eu Md Class 3 | On Market | 1 |
| PureSperm 100 | EU MDD | Eu Md Class 3 | On Market | 1 |
| PureSperm 100 | EU MDD | Eu Md Class 3 | On Market | 1 |
| PureSperm 40 | EU MDD | Eu Md Class 3 | On Market | 1 |
| PureSperm 40/80 | EU MDD | Eu Md Class 3 | On Market | 1 |
| PureSperm 80 | EU MDD | Eu Md Class 3 | On Market | 1 |
| PureSperm 90 | EU MDD | Eu Md Class 3 | On Market | 1 |
| PureSperm Buffer | EU MDD | Eu Md Class 3 | On Market | 1 |
| PureSperm Wash | EU MDD | Eu Md Class 3 | On Market | 1 |
| PureSperm Wash | EU MDD | Eu Md Class 3 | On Market | 1 |
| PureSperm Wash | EU MDD | Eu Md Class 3 | On Market | 1 |
| SpermCryoProtec | EU MDD | Eu Md Class 3 | On Market | 1 |