EU Manufacturer
๐ซ๐ฎ Finland
Active
Berner Oy
SRN: FI-MF-000007402
ยท
Hitsaajankatu 20-24, 00810 Helsinki, Finland
Basic UDI-DIs
22
Total Devices
121
On Market
115
Off Market
6
Certificates
1
Valid
0
Expiring < 6mo
0
Countries
32
Basic Information
- Address
- Hitsaajankatu 20-24, 00810 Helsinki, Finland
- [email protected]
- Website
- www.berner.fi
Regulatory Overview
Regulation
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Eu Mdd
16
Eu Mdr
6
Classification
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Eu Md Class 2a
16
Eu Md Class 1
6
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Expired / Withdrawn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 V | C-01-1127-672-19 | Eurofins Electric & Electronics Finland Oy | Mar 17, 2024 |
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 | ||||
|---|---|---|---|---|
| A12t Dilutus 80% 10 L | EU MDD | Eu Md Class 2a | On Market | 1 |
| A12t Dilutus 80% 100 ml | EU MDD | Eu Md Class 2a | On Market | 1 |
| A12t Dilutus 80% 1L | EU MDD | Eu Md Class 2a | On Market | 1 |
| A12t Dilutus 80% 3 L | EU MDD | Eu Md Class 2a | Off Market | 1 |
| A12t Dilutus 80% 5 L | EU MDD | Eu Md Class 2a | On Market | 1 |
| A12t Dilutus 80% 500 ml | EU MDD | Eu Md Class 2a | On Market | 1 |
| A12t Dilutus 80% Keltainen 1 L | EU MDR | Eu Md Class 1 | On Market | 0 |
| A12t Dilutus 80% Keltainen 500 ml | EU MDR | Eu Md Class 1 | On Market | 0 |
| A12t Dilutus 80% Punainen 500 ml | EU MDR | Eu Md Class 1 | On Market | 0 |
| A12t Dilutus 80% wipe | EU MDD | Eu Md Class 2a | On Market | 1 |
| Bea Pro Nitrile Gloves L | EU MDR | Eu Md Class 1 | On Market | 0 |
| Bea Pro Nitrile Gloves M | EU MDR | Eu Md Class 1 | On Market | 0 |
| Bea Pro Nitrile Gloves S | EU MDR | Eu Md Class 1 | On Market | 0 |
| Bea Pro Nitrile Gloves XL | EU MDR | Eu Md Class 1 | On Market | 0 |
| Bea Pro Nitrile Gloves XS | EU MDR | Eu Md Class 1 | On Market | 0 |
| Bea Pro Vinyylikรคsine L | EU MDR | Eu Md Class 1 | On Market | 0 |
| Bea Pro Vinyylikรคsine M | EU MDR | Eu Md Class 1 | On Market | 0 |
| Bea Pro Vinyylikรคsine S | EU MDR | Eu Md Class 1 | On Market | 0 |
| Bea Pro Vinyylikรคsine XL | EU MDR | Eu Md Class 1 | On Market | 0 |
| Bea Pro Vinyylikรคsine XS | EU MDR | Eu Md Class 1 | On Market | 0 |
| Dermosil Cooling Gel | EU MDR | Eu Md Class 1 | On Market | 0 |
| Desinfektol H 100 ml | EU MDD | Eu Md Class 2a | On Market | 1 |
| Desinfektol H 500 ml | EU MDD | Eu Md Class 2a | On Market | 1 |
| Desinfektol P 100 ml | EU MDD | Eu Md Class 2a | On Market | 1 |
| Desinfektol P 5 L | EU MDD | Eu Md Class 2a | On Market | 1 |
| Desinfektol P 500 ml flip-top | EU MDD | Eu Md Class 2a | On Market | 1 |
| Desinfektol P 500 ml pump | EU MDD | Eu Md Class 2a | On Market | 1 |
| Desiol 5 L | EU MDD | Eu Md Class 2a | On Market | 1 |
| Desiol 500 ml | EU MDD | Eu Md Class 2a | On Market | 1 |
| Fingerbutton | EU MDR | Eu Md Class 1 | On Market | 0 |
| Fingerdual | EU MDR | Eu Md Class 1 | On Market | 0 |
| Five action switch | EU MDR | Eu Md Class 1 | On Market | 0 |
| OL Antistaatti | EU MDD | Eu Md Class 2a | On Market | 1 |
| Orbis Bio-Based Barrier envelopes, size 0 | EU MDR | Eu Md Class 1 | On Market | 0 |
| Orbis Bio-Based Barrier envelopes, size 1 | EU MDR | Eu Md Class 1 | On Market | 0 |
| Orbis Bio-Based Barrier envelopes, size 2 | EU MDR | Eu Md Class 1 | On Market | 0 |
| Orbis Bio-Based Barrier envelopes, size 3 | EU MDR | Eu Md Class 1 | On Market | 0 |
| Orbis Disposable protection covers for cephalostat | EU MDR | Eu Md Class 1 | On Market | 0 |
| Orbis Hygienic protective covers for OPG bite blocks | EU MDR | Eu Md Class 1 | On Market | 0 |
| PSKT1 - Aurora 1 | EU MDR | Eu Md Class 1 | Off Market | 0 |
| PSKT2 - Aurora 2 | EU MDR | Eu Md Class 1 | Off Market | 0 |
| Pikobutton 30 20cm BLACK | EU MDR | Eu Md Class 1 | On Market | 0 |
| Pikobutton 30 20cm BLUE | EU MDR | Eu Md Class 1 | On Market | 0 |
| Pikobutton 30 20cm GOLD | EU MDR | Eu Md Class 1 | On Market | 0 |
| Pikobutton 30 20cm GREEN | EU MDR | Eu Md Class 1 | On Market | 0 |
| Pikobutton 30 20cm ORANGE | EU MDR | Eu Md Class 1 | On Market | 0 |
| Pikobutton 30 20cm RED | EU MDR | Eu Md Class 1 | On Market | 0 |
| Pikobutton 30 20cm SILVER | EU MDR | Eu Md Class 1 | On Market | 0 |
| Pikobutton 30 20cm WHITE | EU MDR | Eu Md Class 1 | On Market | 0 |
| Pikobutton 30 20cm YELLOW | EU MDR | Eu Md Class 1 | On Market | 0 |