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Sol-Millennium CGM WEARABLE SENSOR
EUDAMEDClass IIb (EU MDR)
Ref ZKCTS01105Model CT-302
Identity
- Trade Name
- Sol-Millennium CGM WEARABLE SENSOR EUDAMED
- Device Name
- Sensors of Continuous Glucose Monitoring Systems EUDAMED
- Model / Reference
- CT-302 EUDAMEDZKCTS01105 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06971141200908 EUDAMED
- Basic UDI-DI
- 697114120CT30257 EUDAMED
- EMDN Code
- Z1204011585 INVASIVE BLOOD SUGAR MONITORING SYSTEMS, SINGLE–USE SENSORS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Germany 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
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Sol-Millennium CGM WEARABLE SENSOR by Zhejiang POCTech 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 | 697114120CT30257 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Zhejiang POCTech CO., Ltd.
- EUDAMED SRN
- CN-MF-000024556
- Authorised Representative
- Prolinx GmbH DE-AR-000005129
Sources (1)
- EUDAMED 7adf358f-3dba-4b22-94d3-8450127fd716 61 fields · synced Jul 30, 2026