Identity
- Trade Name
- Syai EUDAMED
- Device Name
- Continuous Glucose Monitoring System EUDAMED
- Model / Reference
- X1 EUDAMEDST12024 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975130610211 EUDAMED
- Basic UDI-DI
- 69751306101UG EUDAMED
- EMDN Code
- Z1204011585 INVASIVE BLOOD SUGAR MONITORING SYSTEMS, SINGLE–USE SENSORS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Slovenia EUDAMED
Clinical & Handling
Sterile
Yes
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
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Syai by Beijing Synapsor Artificial Intelligence Co., Ltd. — Class IIb — 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 | 69751306101UG | Class IIb | Active |
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Manufacturer
- Manufacturer
- Beijing Synapsor Artificial Intelligence Co., Ltd.
- EUDAMED SRN
- CN-MF-000022964
- Authorised Representative
- Luxus Lebenswelt GmbH DE-AR-000005110
Sources (1)
- EUDAMED 82d14230-1d8a-4710-b1cd-5281eb918ac1 61 fields · synced Jun 18, 2026