← Back to catalogue
Continuous Glucose Monitoring System
EUDAMEDClass IIb (EU MDR)
Ref X1Model X1, M8Ref M8
Identity
- Device Name
- Continuous Glucose Monitoring System EUDAMED
- Model / Reference
- X1, M8 EUDAMEDX1 EUDAMEDM8 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08885021260112 EUDAMED08885021260129 EUDAMED
- Basic UDI-DI
- 88850212601VJ EUDAMED
- EMDN Code
- Z1204011585 INVASIVE BLOOD SUGAR MONITORING SYSTEMS, SINGLE–USE SENSORS EUDAMED
Classification
- Device Class
- Class IIb 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
Continuous Glucose Monitoring System 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Syai Health Technology Pte. Ltd.
- EUDAMED SRN
- SG-MF-000041645
- Authorised Representative
- Luxus Lebenswelt GmbH DE-AR-000005110
Sources (2)
- EUDAMED 9cd76daa-29a7-454c-abca-1208013ae1c6 61 fields · synced Jul 8, 2026
- EUDAMED 5554e68d-4004-4966-93c7-1ece2c7a5e3b 61 fields · synced May 17, 2026