EU Manufacturer
🇫🇮 Finland
Active
Forsante Oy
SRN: FI-MF-000008137
·
Heikkiläntie 2, 00210 Helsinki, Finland
Basic UDI-DIs
3
Total Devices
3
On Market
3
Off Market
0
Certificates
1
Valid
0
Expiring < 6mo
0
Countries
5
Basic Information
- Address
- Heikkiläntie 2, 00210 Helsinki, Finland
- [email protected]
- Website
- www.forsante.com
Regulatory Overview
Regulation
Loading...
Eu Mdd
1
Eu Mdr
1
Eu Ivdd
1
Classification
Loading...
Eu Md Class 2b
2
Eu Ivd General
1
Device Types
Loading...
Certificate Health
Total
1
Valid
0
Expiring < 6mo
0
Expired / Withdrawn
1
Certificates by Expiry Year
Loading...
| Type | Number | Expiry Date | Status | |||
|---|---|---|---|---|---|---|
| MDD Annex II (excluding section 4) | FI21/07045P0 | SGS FIMKO OY | Sep 25, 2023 |
Market Presence
Devices from this manufacturer are available in 5 countries across Europe.
🇪🇪 Estonia
🇫🇮 Finland
🇳🇱 Netherlands
🇵🇱 Poland
🇸🇪 Sweden
Device Portfolio
| Name | ||||
|---|---|---|---|---|
| IRMA | EU MDR | Eu Md Class 2b | On Market | 0 |
| Prostate Cancer Advisor | EU IVDD | Eu Ivd General | On Market | 0 |
| Warfarin Advisor | EU MDD | Eu Md Class 2b | On Market | 1 |