EU Manufacturer
๐ซ๐ฎ Finland
Active
Bittium Biosignals Ltd
SRN: FI-MF-000013983
ยท
Pioneerinkatu 6, 70800 Kuopio, Finland
Basic UDI-DIs
16
Total Devices
22
On Market
22
Off Market
0
Certificates
1
Valid
0
Expiring < 6mo
0
Countries
32
Basic Information
- Address
- Pioneerinkatu 6, 70800 Kuopio, Finland
- [email protected]
- Website
- https://www.bittium.com/medical
Regulatory Overview
Regulation
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Eu Mdd
9
Eu Mdr
7
Classification
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Eu Md Class 2a
11
Eu Md Class 1
4
Eu Md Class 2b
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Expired / Withdrawn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 II Section 4 | C-01-1030-730-20 | 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 | ||||
|---|---|---|---|---|
| Bittium APV20 | EU MDR | Eu Md Class 2a | On Market | 0 |
| Bittium Physior | EU MDR | Eu Md Class 1 | On Market | 0 |
| Bittium Respiro | EU MDR | Eu Md Class 2a | On Market | 0 |
| Bittium Respiro Analyst | EU MDR | Eu Md Class 2a | On Market | 0 |
| BrainStatus EEG electrode | EU MDR | Eu Md Class 1 | On Market | 0 |
| ECG HOLTER RECORDERS | EU MDD | Eu Md Class 2a | On Market | 1 |
| ECG HOLTER RECORDERS | EU MDD | Eu Md Class 2a | On Market | 1 |
| ECG HOLTER RECORDERS | EU MDD | Eu Md Class 2a | On Market | 1 |
| ECG HOLTER RECORDERS | EU MDD | Eu Md Class 2a | On Market | 1 |
| ELECTROCARDIOGRAPHS - MEDICAL DEVICE SOFTWARE | EU MDD | Eu Md Class 2a | On Market | 1 |
| ELECTROENCEPHALOGRAPHS | EU MDD | Eu Md Class 2b | On Market | 1 |
| ELECTROENCEPHALOGRAPHS | EU MDD | Eu Md Class 2a | On Market | 1 |
| IEC 2-electrode 1-CH patient cable 125 mm | EU MDR | Eu Md Class 1 | On Market | 0 |
| MEASUREMENT DEVICES - OTHER | EU MDD | Eu Md Class 2a | On Market | 1 |
| MEDICAL DEVICE SOFTWARE - NOT INCLUDED IN OTHER CLASSES | EU MDD | Eu Md Class 2a | On Market | 1 |
| Mini UL | EU MDR | Eu Md Class 2a | On Market | 0 |
| MiniSnap Sensitive 1-CH ECG Electrode | EU MDR | Eu Md Class 1 | On Market | 0 |
| OmegaSnap 1-CH Adapter | EU MDR | Eu Md Class 1 | On Market | 0 |
| OmegaSnap 1-CH ECG Electrode | EU MDR | Eu Md Class 1 | On Market | 0 |
| OmegaSnap 2-CH ECG Electrode | EU MDR | Eu Md Class 1 | On Market | 0 |
| OmegaSnap 3-CH ECG Electrode | EU MDR | Eu Md Class 1 | On Market | 0 |
| OmegaSnap Multi-CH Adapter | EU MDR | Eu Md Class 1 | On Market | 0 |