EU Manufacturer
๐ธ๐ช Sweden
Active
Nidacon International AB
SRN: SE-MF-000001933
ยท
Flรถjelbergsgatan 16B, 43137 Mรถlndal, Sweden
Basic UDI-DIs
15
Total Devices
15
On Market
15
Off Market
0
Certificates
4
Valid
0
Expiring < 6mo
0
Countries
32
Watch Nidacon International AB for changes
We'll email you when it registers new devices, or a certificate is issued or withdrawn.
Basic Information
- Address
- Flรถjelbergsgatan 16B, 43137 Mรถlndal, 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Expired / Withdrawn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.
๐ฆ๐น Austria
๐ง๐ช Belgium
๐ง๐ฌ Bulgaria
๐จ๐พ Cyprus
๐จ๐ฟ Czechia
๐ฉ๐ช Germany
๐ฉ๐ฐ Denmark
๐ช๐ช Estonia
๐ฌ๐ท Greece
๐ช๐ธ Spain
๐ซ๐ฎ Finland
๐ซ๐ท France
๐ญ๐ท Croatia
๐ญ๐บ Hungary
๐ฎ๐ช Ireland
๐ฎ๐ธ Iceland
๐ฎ๐น Italy
๐ฑ๐ฎ Liechtenstein
๐ฑ๐น Lithuania
๐ฑ๐บ Luxembourg
๐ฑ๐ป Latvia
๐ฒ๐น Malta
๐ณ๐ฑ Netherlands
๐ณ๐ด Norway
๐ต๐ฑ Poland
๐ต๐น Portugal
๐ท๐ด Romania
๐ธ๐ช Sweden
๐ธ๐ฎ Slovenia
๐ธ๐ฐ Slovakia
๐น๐ท Tรผrkiye
๐ฌ๐ง 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 |