Identity
- Trade Name
- Sunrise sensor EUDAMED
- Device Name
- Sunrise sensor EUDAMED
- Model / Reference
- SUN100 EUDAMEDA200 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05430001896008 EUDAMED
- Basic UDI-DI
- 5430001896SunriseDxSenQU EUDAMED
- EMDN Code
- Z1399 NON-SPECIFIC CONSUMABLES FOR DIAGNOSTIC INSTRUMENTS - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Belgium EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Sunrise sensor by Sunrise SA — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 5430001896SunriseDxSenQU | Class I | Active |
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Manufacturer
- Manufacturer
- Sunrise SA
- EUDAMED SRN
- BE-MF-000000105
Sources (1)
- EUDAMED ddb00753-62e1-453a-8d17-9f2ca9adf0ca 61 fields · synced Jun 18, 2026