EU Manufacturer
🇩🇪 Germany
Active
Roche Diagnostics GmbH
SRN: DE-MF-000006260
·
Sandhofer Str. 116 , 68305 Mannheim , Germany
Basic UDI-DIs
2
Total Devices
2
On Market
2
Off Market
0
Certificates
1
Valid
0
Expiring < 6mo
0
Countries
5
Basic Information
- Address
- Sandhofer Str. 116 , 68305 Mannheim , Germany
- [email protected]
- Website
- www.roche.com
Regulatory Overview
Regulation
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Eu Ivdd
2
Classification
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Eu Ivd Self Testing
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Expired / Withdrawn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 | |||
|---|---|---|---|---|---|---|
| IVDD Annex IV (excluding sections 4, 6) | V1 010283 0604 | TÜV SÜD Product Service GmbH | May 26, 2025 |
Market Presence
Devices from this manufacturer are available in 5 countries across Europe.
🇩🇪 Germany
🇩🇰 Denmark
🇫🇮 Finland
🇳🇴 Norway
🇸🇪 Sweden
Device Portfolio
| Name | ||||
|---|---|---|---|---|
| CoaguChek INRange | EU IVDD | Eu Ivd Self Testing | On Market | 1 |
| CoaguChek XS System | EU IVDD | Eu Ivd Self Testing | On Market | 1 |