EU Manufacturer
🇫🇮 Finland
Active
CGI Suomi Oy
SRN: FI-MF-000012661
·
Karvaamokuja 2 D, 00380 Helsinki, Finland
Basic UDI-DIs
5
Total Devices
5
On Market
5
Off Market
0
Certificates
2
Valid
1
Expiring < 6mo
0
Countries
1
Basic Information
- Address
- Karvaamokuja 2 D, 00380 Helsinki, Finland
- [email protected]
- Phone
- +358 10302010
Regulatory Overview
Regulation
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Eu Mdd
4
Eu Mdr
1
Classification
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Eu Md Class 2b
3
Eu Md Class 1
2
Device Types
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Certificate Health
Total
2
Valid
1
Expiring < 6mo
0
Expired / Withdrawn
1
Certificates by Expiry Year
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| Type | Number | Expiry Date | Status | |||
|---|---|---|---|---|---|---|
| MDD Annex II (excluding section 4) | C-01-1156-735-20 | Eurofins Electric & Electronics Finland Oy | May 28, 2024 | |||
| MDR QMS | CR-03-1156-859-24 | Eurofins Electric & Electronics Finland Oy | MDR | Dec 2024 | Dec 09, 2029 | Issued |
Market Presence
Devices from this manufacturer are available in 1 country across Europe.
🇫🇮 Finland
Device Portfolio
| Name | ||||
|---|---|---|---|---|
| GENERAL MEDICINE THERAPEUTIC TREATMENT INSTRUMENTS - MEDICAL DEVICE SOFTWARE | EU MDR | Eu Md Class 2b | On Market | 0 |
| Kemokur | EU MDD | Eu Md Class 2b | On Market | 1 |
| Merlot Medi Physio | EU MDD | Eu Md Class 2b | On Market | 1 |
| OMNI360 Kertomus | EU MDD | Eu Md Class 1 | On Market | 0 |
| Pegasos | EU MDD | Eu Md Class 1 | On Market | 0 |