Identity
- Trade Name
- DiaExpert EUDAMED
- Device Name
- Continuous Glucose Monitoring System sensor EUDAMED
- Model / Reference
- GX-01F, GX-02F EUDAMEDC046020,C046021 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06958590312772 EUDAMED
- Basic UDI-DI
- 69585903Z120401GXE4Y EUDAMED
- Direct Marketing DI
- 06958590312772 EUDAMED
- EMDN Code
- Z1204011585 INVASIVE BLOOD SUGAR MONITORING SYSTEMS, SINGLE–USE SENSORS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Netherlands 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
DiaExpert by Microtech Medical (hangzhou) 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 | 69585903Z120401GXE4Y | Class IIb | Active |
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Manufacturer
- Manufacturer
- MicroTech Medical (Hangzhou) Co., Ltd.
- EUDAMED SRN
- CN-MF-000001157
- Authorised Representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Sources (2)
- EUDAMED 22d7f80c-6055-4e7f-a65b-b22d8b7c586c 61 fields · synced Jul 10, 2026
- EUDAMED 22d7f80c-6055-4e7f-a65b-b22d8b7c586c-1 61 fields · synced Jun 9, 2026