EU Manufacturer
🇮🇹 Italy
Active
S.I.D.EM. S.p.A.
SRN: IT-MF-000029977
·
Via Bergamo 94, 20882 Bellusco (MB), Italy
Basic UDI-DIs
5
Total Devices
5
On Market
5
Off Market
0
Certificates
2
Valid
0
Expiring < 6mo
0
Countries
4
Basic Information
- Address
- Via Bergamo 94, 20882 Bellusco (MB), Italy
- [email protected]
- Phone
- +393518009161
- Website
- https://www.sidemspa.com/
Regulatory Overview
Regulation
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Eu Mdd
5
Classification
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Eu Md Class 1
3
Eu Md Class 2b
2
Device Types
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Certificate Health
Total
2
Valid
0
Expiring < 6mo
0
Expired / Withdrawn
2
Certificates by Expiry Year
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| Type | Number | Expiry Date | Status | |||
|---|---|---|---|---|---|---|
| MDD Annex V | G2M0765960009 | TÜV SÜD Product Service GmbH | May 26, 2024 | |||
| MDD Annex II (excluding section 4) | G10765960008 | TÜV SÜD Product Service GmbH | May 26, 2024 |
Market Presence
Devices from this manufacturer are available in 4 countries across Europe.
🇩🇪 Germany
🇩🇰 Denmark
🇮🇪 Ireland
🇮🇹 Italy
Device Portfolio
| Name | ||||
|---|---|---|---|---|
| DIAGNOSTIC REGISTRATION PAPERS | EU MDD | Eu Md Class 1 | On Market | 1 |
| DIAGNOSTIC REGISTRATION PAPERS | EU MDD | Eu Md Class 1 | On Market | 1 |
| DIAGNOSTIC REGISTRATION PAPERS | EU MDD | Eu Md Class 1 | On Market | 1 |
| TEE Care System | EU MDD | Eu Md Class 2b | On Market | 1 |
| TEE Care System | EU MDD | Eu Md Class 2b | On Market | 1 |