Identity
- Trade Name
- Syai EUDAMED
- Device Name
- Continuous Glucose Monitoring System EUDAMED
- Model / Reference
- X1, M8 EUDAMEDSF12024 EUDAMEDST12024 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08885021260013 EUDAMED08885021260037 EUDAMED08885021260051 EUDAMED
- Basic UDI-DI
- 88850212601VJ EUDAMED
- EMDN Code
- Z1204011585 INVASIVE BLOOD SUGAR MONITORING SYSTEMS, SINGLE–USE SENSORS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Italy EUDAMEDGreece EUDAMEDSlovakia 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 Syai Health Technology Pte. 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 | 88850212601VJ | Class IIb | Active |
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Manufacturer
- Manufacturer
- Syai Health Technology Pte. Ltd.
- EUDAMED SRN
- SG-MF-000041645
- Authorised Representative
- Luxus Lebenswelt GmbH DE-AR-000005110
Sources (3)
- EUDAMED 1afdf20a-b491-4845-a28b-b6a582f9beca 61 fields · synced Jul 13, 2026
- EUDAMED ed7fc2fe-dcd7-42fc-a020-5c5351c3d55a 61 fields · synced May 17, 2026
- EUDAMED 624f187d-314b-45ce-9b45-b3b56f338304 61 fields · synced May 19, 2026