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Sunrise sensor
EUDAMEDFDA 510(k)Class I (EU MDR)
Ref A202Model SUN100
by Sunrise SA
Identity
- Trade Name
- Sunrise sensor EUDAMED
- Device Name
- Sunrise sensor EUDAMED
- Model / Reference
- SUN100 EUDAMEDA202 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05430001896138 EUDAMED
- Basic UDI-DI
- 5430001896SunriseDxSenQU EUDAMED
- EMDN Code
- Z1399 NON-SPECIFIC CONSUMABLES FOR DIAGNOSTIC INSTRUMENTS - OTHER EUDAMED
Classification
- Device Class
- Class I 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 — FDA_510K, MDR — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K250874 | Class I | Active |
| FDA 510(k) | United States | FDA_510K | K222262 | Class I | Active |
| EUDAMED | European Union | CE/MDR | 5430001896SunriseDxSenQU | Class I | Active |
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Manufacturer
- Manufacturer
- Sunrise SA
- EUDAMED SRN
- BE-MF-000000105
Sources (2)
- EUDAMED 931a6d36-182f-4704-b3f0-49af63815eb6 61 fields · synced Jun 18, 2026
- FDA 510(k) K250874 1 fields · synced May 18, 2026