EU Manufacturer
🇫🇮 Finland
Active
Galena Pharma Oy
SRN: FI-MF-000000588
·
Sammonkatu 10, 70500 Kuopio, Finland
Basic UDI-DIs
53
Total Devices
62
On Market
60
Off Market
2
Certificates
2
Valid
0
Expiring < 6mo
0
Countries
2
Basic Information
- Address
- Sammonkatu 10, 70500 Kuopio, Finland
- [email protected]
- Website
- www.galena.fi
Regulatory Overview
Regulation
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Eu Mdd
48
Eu Mdr
5
Classification
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Eu Md Class 1
25
Eu Md Class 2a
18
Eu Md Class 2b
10
Certificate Health
Total
2
Valid
0
Expiring < 6mo
0
Expired / Withdrawn
2
Certificates by Expiry Year
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| Type | Number | Expiry Date | Status | |||
|---|---|---|---|---|---|---|
| MDD Annex II Section 4 | C-01-1162-775-21 | Eurofins Electric & Electronics Finland Oy | Mar 06, 2023 | |||
| MDD Annex II (excluding section 4) | C01-1162-775-21 | Eurofins Electric & Electronics Finland Oy | Mar 07, 2023 |
Market Presence
Devices from this manufacturer are available in 2 countries across Europe.
🇫🇮 Finland
🇸🇪 Sweden
Device Portfolio
| Name | ||||
|---|---|---|---|---|
| Apteekki Antiseptinen Haavanpuhdiste 100 ml | EU MDD | Eu Md Class 2a | On Market | 1 |
| Apteekki Antiseptinen Haavanpuhdiste 100 ml suihke | EU MDD | Eu Md Class 2a | On Market | 1 |
| Apteekki Antiseptinen Haavanpuhdiste 300 ml | EU MDD | Eu Md Class 2a | On Market | 1 |
| Apteekki Hoitava Nenäsumute Dekspantenoli 25 ml | EU MDD | Eu Md Class 1 | On Market | 0 |
| Apteq Fluzinc Hunaja 24 tabl. | EU MDD | Eu Md Class 1 | On Market | 0 |
| Apteq Fluzinc Hunaja 72 tabl. | EU MDD | Eu Md Class 1 | On Market | 0 |
| Apteq Fluzinc Mustaherukka 24 tabl. | EU MDD | Eu Md Class 1 | On Market | 0 |
| Apteq Fluzinc Mustaherukka 72 tabl. | EU MDD | Eu Md Class 1 | On Market | 0 |
| Apteq Fluzinc Salmiakki 24 tabl. | EU MDD | Eu Md Class 1 | On Market | 0 |
| Apteq Fluzinc Salmiakki 72 tabl. | EU MDD | Eu Md Class 1 | On Market | 0 |
| Apteq Fluzinc Salmiakki suihke 25 ml | EU MDD | Eu Md Class 1 | On Market | 0 |
| Apteq Mielikki 200 ml | EU MDD | Eu Md Class 1 | On Market | 0 |
| Ceraderm Betaglucan 150g | EU MDD | Eu Md Class 2a | On Market | 1 |
| Ceraderm Betaglucan 30g | EU MDD | Eu Md Class 2a | On Market | 1 |
| Ceraderm Intime 100ml | EU MDD | Eu Md Class 2b | On Market | 1 |
| Femisan Balance 7x5ml | EU MDD | Eu Md Class 2a | On Market | 1 |
| Femisan Balance emätingeeli 7x5ml | EU MDR | Eu Md Class 2b | On Market | 0 |
| Femisan Cream emätinvoide 50 g | EU MDR | Eu Md Class 2b | On Market | 0 |
| Galax peräruiske 12x5ml | EU MDR | Eu Md Class 2b | On Market | 0 |
| Galax peräruiske 2x5ml | EU MDR | Eu Md Class 2b | On Market | 0 |
| Galax peräruiske 4x5ml | EU MDR | Eu Md Class 2b | On Market | 0 |
| Kylmägeeli ratiopharm 150 ml | EU MDD | Eu Md Class 1 | On Market | 0 |
| Mobilat Ice Strong 150 ml | EU MDD | Eu Md Class 1 | On Market | 0 |
| Mobilat Ice Strong 75 ml roll on | EU MDD | Eu Md Class 1 | On Market | 0 |
| Mobilat Ice Strong 75 ml roll-on | EU MDD | Eu Md Class 1 | On Market | 0 |
| Otocur 25 ml | EU MDD | Eu Md Class 2a | On Market | 1 |
| Otocur 30ml | EU MDD | Eu Md Class 2a | On Market | 1 |
| Otocur korvasuihke 30 ml | EU MDR | Eu Md Class 2a | On Market | 0 |
| Otocur korvatipat 25 ml | EU MDR | Eu Md Class 2a | On Market | 0 |
| Quicklax mikrolavemang 12x5ml | EU MDR | Eu Md Class 2b | On Market | 0 |
| Quicklax mikrolavemang 4x5ml | EU MDR | Eu Md Class 2b | On Market | 0 |
| Refenum Ice 150 ml | EU MDD | Eu Md Class 1 | On Market | 0 |
| Refenum Ice 50 ml | EU MDD | Eu Md Class 1 | On Market | 0 |
| Simex 80 mg 100 tablettia | EU MDD | Eu Md Class 2a | On Market | 1 |
| Simex 80 mg 20 tablettia | EU MDD | Eu Md Class 2a | On Market | 1 |
| Smartlax peräruiske 12x5ml | EU MDD | Eu Md Class 1 | On Market | 0 |
| Smartlax peräruiske 4x5ml | EU MDR | Eu Md Class 2b | On Market | 0 |
| Smartlax peräruiske 4x5ml | EU MDD | Eu Md Class 1 | On Market | 0 |
| Smartlax peräruiske 50x5ml | EU MDR | Eu Md Class 2b | On Market | 0 |
| Smartlax peräruiske 50x5ml | EU MDD | Eu Md Class 1 | On Market | 0 |
| Synomax Lihasgeeli 100 ml | EU MDD | Eu Md Class 1 | Off Market | 0 |
| Synomax Nivelgeeli 100 ml | EU MDD | Eu Md Class 1 | Off Market | 0 |
| Wonderm Antisepti 100 ml | EU MDD | Eu Md Class 2a | On Market | 1 |
| Wonderm Antisepti 100 ml suihke | EU MDD | Eu Md Class 2a | On Market | 1 |
| Xyliderm 100ml | EU MDD | Eu Md Class 2a | On Market | 1 |
| Xyliderm 500ml | EU MDD | Eu Md Class 2a | On Market | 1 |
| YA A-vitamiini nenäsuihke 25 ml | EU MDD | Eu Md Class 1 | On Market | 0 |
| YA Dekspantenoli nenäsuihke 25ml | EU MDD | Eu Md Class 1 | On Market | 0 |
| YA Emätingeeli 7x5ml | EU MDD | Eu Md Class 2a | On Market | 1 |
| YA Haavapuhdiste 100 ml | EU MDD | Eu Md Class 2a | On Market | 1 |