EU Manufacturer
๐ซ๐ฎ Finland
Active
Biohit Oyj
SRN: FI-MF-000014642
ยท
Laippatie 1, 00880 Helsinki, Finland
Basic UDI-DIs
40
Total Devices
41
On Market
37
Off Market
4
Certificates
1
Valid
0
Expiring < 6mo
0
Countries
32
Basic Information
- Address
- Laippatie 1, 00880 Helsinki, Finland
- [email protected]
- Phone
- +358 9 773 861
- Website
- www.biohithealthcare.com
Regulatory Overview
Regulation
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Eu Ivdd
35
Eu Ivdr
3
Eu Mdd
2
Classification
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Eu Ivd General
35
Eu Ivd Class A
3
Eu Md Class 1
1
Eu Md Class 2a
1
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Expired / Withdrawn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-01-1140-725-20 | Eurofins Electric & Electronics Finland Oy | May 26, 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 | ||||
|---|---|---|---|---|
| Acetium 100 mg | EU MDD | Eu Md Class 2a | On Market | 1 |
| Acetium lozenge - quit smoking | EU MDD | Eu Md Class 1 | On Market | 0 |
| BIOHIT Active B12 (HoloTC) | EU IVDD | Eu Ivd General | On Market | 0 |
| BIOHIT Calprotectin | EU IVDD | Eu Ivd General | On Market | 0 |
| BIOHIT Celiac quick test | EU IVDD | Eu Ivd General | On Market | 0 |
| BIOHIT Celiac quick test | EU IVDD | Eu Ivd General | On Market | 0 |
| BIOHIT ColonView QT Control | EU IVDD | Eu Ivd General | On Market | 0 |
| BIOHIT ColonView quick test | EU IVDD | Eu Ivd General | On Market | 0 |
| BIOHIT Extraction tubes | EU IVDR | Eu Ivd Class A | On Market | 0 |
| BIOHIT FAEX Sample System | EU IVDR | Eu Ivd Class A | On Market | 0 |
| BIOHIT FAEX Sample System | EU IVDR | Eu Ivd Class A | On Market | 0 |
| BIOHIT Lactase Control | EU IVDD | Eu Ivd General | On Market | 0 |
| BIOHIT Total 25OH Vitamin D | EU IVDD | Eu Ivd General | On Market | 0 |
| BIOHIT ๐๐ฆ๐ญ๐ช๐ค๐ฐ๐ฃ๐ข๐ค๐ต๐ฆ๐ณ ๐ฑ๐บ๐ญ๐ฐ๐ณ๐ช Control | EU IVDD | Eu Ivd General | On Market | 0 |
| BIOHIT ๐๐ฆ๐ญ๐ช๐ค๐ฐ๐ฃ๐ข๐ค๐ต๐ฆ๐ณ ๐ฑ๐บ๐ญ๐ฐ๐ณ๐ช UFT300 | EU IVDD | Eu Ivd General | On Market | 0 |
| BIOHIT ๐๐ฆ๐ญ๐ช๐ค๐ฐ๐ฃ๐ข๐ค๐ต๐ฆ๐ณ ๐ฑ๐บ๐ญ๐ฐ๐ณ๐ช UFT300 | EU IVDD | Eu Ivd General | On Market | 0 |
| BIOHIT ๐๐ฆ๐ญ๐ช๐ค๐ฐ๐ฃ๐ข๐ค๐ต๐ฆ๐ณ ๐ฑ๐บ๐ญ๐ฐ๐ณ๐ช UFT300 | EU IVDD | Eu Ivd General | On Market | 0 |
| BIOHIT ๐๐ฆ๐ญ๐ช๐ค๐ฐ๐ฃ๐ข๐ค๐ต๐ฆ๐ณ ๐ฑ๐บ๐ญ๐ฐ๐ณ๐ช UFT300 | EU IVDD | Eu Ivd General | On Market | 0 |
| GP Reader | EU IVDD | Eu Ivd General | Off Market | 0 |
| GP Reader NT | EU IVDD | Eu Ivd General | Off Market | 0 |
| GP Reader NT | EU IVDR | Eu Ivd Class A | On Market | 0 |
| Gastrin-17 Advanced | EU IVDD | Eu Ivd General | On Market | 0 |
| GastroPanel Four-in-Oneแตแดน | EU IVDD | Eu Ivd General | On Market | 0 |
| GastroPanelยฎ Gastrin-17 | EU IVDD | Eu Ivd General | On Market | 0 |
| GastroPanelยฎ Pepsinogen I | EU IVDD | Eu Ivd General | On Market | 0 |
| GastroPanelยฎ Pepsinogen II | EU IVDD | Eu Ivd General | On Market | 0 |
| GastroPanelยฎ Stabilizer | EU IVDD | Eu Ivd General | On Market | 0 |
| GastroPanelยฎ Stabilizer | EU IVDD | Eu Ivd General | On Market | 0 |
| GastroPanelยฎ Unified | EU IVDD | Eu Ivd General | On Market | 0 |
| GastroPanelยฎ quick test | EU IVDD | Eu Ivd General | Off Market | 0 |
| GastroPanelยฎ quick test NT | EU IVDD | Eu Ivd General | On Market | 0 |
| GastroPanelยฎ quick test NT | EU IVDD | Eu Ivd General | On Market | 0 |
| GastroPanelยฎ ๐๐ฆ๐ญ๐ช๐ค๐ฐ๐ฃ๐ข๐ค๐ต๐ฆ๐ณ ๐ฑ๐บ๐ญ๐ฐ๐ณ๐ช | EU IVDD | Eu Ivd General | On Market | 0 |
| GastroSoft | EU IVDD | Eu Ivd General | On Market | 0 |
| Lactose Intolerance quick test | EU IVDD | Eu Ivd General | On Market | 0 |
| Lactose Intolerance quick test | EU IVDD | Eu Ivd General | On Market | 0 |
| Pepsinogen I | EU IVDD | Eu Ivd General | On Market | 0 |
| Pepsinogen II | EU IVDD | Eu Ivd General | On Market | 0 |
| Quick Test Reader | EU IVDD | Eu Ivd General | Off Market | 0 |
| ๐๐ฆ๐ญ๐ช๐ค๐ฐ๐ฃ๐ข๐ค๐ต๐ฆ๐ณ ๐ฑ๐บ๐ญ๐ฐ๐ณ๐ช IgG | EU IVDD | Eu Ivd General | On Market | 0 |
| ๐๐ฆ๐ญ๐ช๐ค๐ฐ๐ฃ๐ข๐ค๐ต๐ฆ๐ณ ๐ฑ๐บ๐ญ๐ฐ๐ณ๐ช quick test | EU IVDD | Eu Ivd General | On Market | 0 |