EU Manufacturer
🇩🇪 Germany
Active
SOMNOmedics AG
SRN: DE-MF-000006921
·
Am Sonnenstuhl 63, 97236 Randersacker, Germany
Basic UDI-DIs
1
Total Devices
1
On Market
1
Off Market
0
Certificates
1
Valid
0
Expiring < 6mo
0
Countries
3
Basic Information
- Address
- Am Sonnenstuhl 63, 97236 Randersacker, Germany
- [email protected]
- Website
- somnomedics.de
Regulatory Overview
Regulation
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Eu Mdd
1
Classification
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Eu Md Class 2a
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Expired / Withdrawn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 (excluding section 4) | 390353 MR2 | DQS Medizinprodukte GmbH | May 26, 2024 |
Market Presence
Devices from this manufacturer are available in 3 countries across Europe.
🇦🇹 Austria
🇩🇪 Germany
🇮🇹 Italy
Device Portfolio
| Name | ||||
|---|---|---|---|---|
| SOMNOtouch RESP | EU MDD | Eu Md Class 2a | On Market | 1 |