EU Manufacturer
๐ซ๐ฎ Finland
Active
Salofa Oy
SRN: FI-MF-000016823
ยท
Satamakatu 16, 24100 Salo, Finland
Basic UDI-DIs
31
Total Devices
31
On Market
30
Off Market
1
Certificates
1
Valid
0
Expiring < 6mo
0
Countries
14
Basic Information
- Address
- Satamakatu 16, 24100 Salo, Finland
- [email protected]
- Website
- www.salofa.com
Regulatory Overview
Regulation
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Eu Ivdd
22
Eu Mdd
9
Classification
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Eu Ivd General
22
Eu Md Class 2a
9
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Expired / Withdrawn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) | 248911-2017-CE-FIN-NA-PS | DNV Product Assurance AS | May 26, 2024 |
Market Presence
Devices from this manufacturer are available in 14 countries across Europe.
๐ฆ๐น Austria
๐จ๐ฟ Czechia
๐ฉ๐ช Germany
๐ฌ๐ท Greece
๐ช๐ธ Spain
๐ซ๐ฎ Finland
๐ซ๐ท France
๐ญ๐บ Hungary
๐ฎ๐น Italy
๐ณ๐ฑ Netherlands
๐ณ๐ด Norway
๐ต๐ฑ Poland
๐ท๐ด Romania
๐ธ๐ฎ Slovenia
Device Portfolio
| Name | ||||
|---|---|---|---|---|
| CT Filling Set 120 cm | EU MDD | Eu Md Class 2a | On Market | 1 |
| CT Patient Line 120 cm (300 psi) | EU MDD | Eu Md Class 2a | On Market | 1 |
| CT Patient Line 20 cm (300 psi) | EU MDD | Eu Md Class 2a | On Market | 1 |
| CT Patient Line 40 cm (300 psi) | EU MDD | Eu Md Class 2a | On Market | 1 |
| CT Patient Line 40 cm (300 psi), 2 valves | EU MDD | Eu Md Class 2a | On Market | 1 |
| CT Patient Line 40 cm (300 psi), 2 valves, RA | EU MDD | Eu Md Class 2a | On Market | 1 |
| CT Patient Line 75 cm (300 psi) | EU MDD | Eu Md Class 2a | On Market | 1 |
| CT Patient Line 75 cm (300 psi), 2 valves | EU MDD | Eu Md Class 2a | On Market | 1 |
| CT Patient Line 75 cm (300 psi), soft | EU MDD | Eu Md Class 2a | On Market | 1 |
| DRUGS OF ABUSE/TOXICOLOGY RT & POC - OTHER | EU IVDD | Eu Ivd General | On Market | 0 |
| DRUGS OF ABUSE/TOXICOLOGY RT & POC - OTHER | EU IVDD | Eu Ivd General | On Market | 0 |
| FECAL OCCULT BLOOD - RT & POC | EU IVDD | Eu Ivd General | On Market | 0 |
| FECAL OCCULT BLOOD - RT & POC | EU IVDD | Eu Ivd General | On Market | 0 |
| FECAL OCCULT BLOOD - RT & POC | EU IVDD | Eu Ivd General | On Market | 0 |
| FECAL OCCULT BLOOD - RT & POC | EU IVDD | Eu Ivd General | On Market | 0 |
| FECAL OCCULT BLOOD - RT & POC | EU IVDD | Eu Ivd General | On Market | 0 |
| FECAL OCCULT BLOOD - RT & POC | EU IVDD | Eu Ivd General | On Market | 0 |
| MULTIPLE DRUGS OF ABUSE/TOXICOLOGY RT & POC | EU IVDD | Eu Ivd General | On Market | 0 |
| MULTIPLE DRUGS OF ABUSE/TOXICOLOGY RT & POC | EU IVDD | Eu Ivd General | On Market | 0 |
| MULTIPLE DRUGS OF ABUSE/TOXICOLOGY RT & POC | EU IVDD | Eu Ivd General | On Market | 0 |
| MULTIPLE DRUGS OF ABUSE/TOXICOLOGY RT & POC | EU IVDD | Eu Ivd General | On Market | 0 |
| Reader-1-S | EU IVDD | Eu Ivd General | Off Market | 0 |
| STREP. A - RT & POC | EU IVDD | Eu Ivd General | On Market | 0 |
| VIROLOGY - RT & POC - OTHER | EU IVDD | Eu Ivd General | On Market | 0 |
| VIROLOGY - RT & POC - OTHER | EU IVDD | Eu Ivd General | On Market | 0 |
| VIROLOGY - RT & POC - OTHER | EU IVDD | Eu Ivd General | On Market | 0 |
| VIROLOGY - RT & POC - OTHER | EU IVDD | Eu Ivd General | On Market | 0 |
| VIROLOGY - RT & POC - OTHER | EU IVDD | Eu Ivd General | On Market | 0 |
| VIROLOGY - RT & POC - OTHER | EU IVDD | Eu Ivd General | On Market | 0 |
| VIROLOGY - RT & POC - OTHER | EU IVDD | Eu Ivd General | On Market | 0 |
| VIROLOGY - RT & POC - OTHER | EU IVDD | Eu Ivd General | On Market | 0 |