DiaExpert
by MicroTech Medical (Hangzhou) Co., Ltd. 6 variants
Ref C046000Model GX-01F, GX-02F
Active
CE MDR
Valid until
Not listed
FDA recalls
Not applicable
Documents
None linked in EUDAMED
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number69585903Z120401GXE4Y 06958590309628 | Date3 Apr 2025 | StatusActive |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Continuous Glucose Monitoring System sensor
- Model / Reference
- GX-01F, GX-02F, C046000
- Primary DI / UDI-DI
- 06958590309628
- Basic UDI-DI
- 69585903Z120401GXE4Y
- EMDN Code
- Z1204011585 Invasive blood sugar monitoring systems, single–use sensors
- Device Class
- Class IIb
- EU market of registration
- Germany
Manufacturer details
- EUDAMED SRN
- CN-MF-000001157
- Authorised representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Other devices from Microtech Medical (Hangzhou) Co., Ltd.
See all devices from Microtech Medical (Hangzhou) Co., Ltd. →
Properties
Other properties (11)
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Incorporates Medicinal Product: No