EU Manufacturer
🇨🇭 Switzerland
Active
SmartCardia SA
SRN: CH-MF-000030647
·
EPFL Innovation Park, Bâtiment C, 1015 LAUSANNE, Switzerland
Basic UDI-DIs
2
Total Devices
2
On Market
2
Off Market
0
Certificates
1
Valid
0
Expiring < 6mo
0
Countries
1
Basic Information
- Address
- EPFL Innovation Park, Bâtiment C, 1015 LAUSANNE, Switzerland
- [email protected]
- Website
- https://www.smartcardia.com/
Regulatory Overview
Regulation
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Eu Mdd
2
Classification
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Eu Md Class 2a
2
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Expired / Withdrawn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 (excluding section 4) | 1260C04200201 | HTCert (Health Technology Certification Ltd) | May 25, 2024 |
Market Presence
Devices from this manufacturer are available in 1 country across Europe.
🇳🇱 Netherlands
Device Portfolio
| Name | ||||
|---|---|---|---|---|
| ScaAI Patch | EU MDD | Eu Md Class 2a | On Market | 1 |
| ScaAI Patch Device | EU MDD | Eu Md Class 2a | On Market | 1 |