Transmiters of Continuous Glucose Monitoring Systems
by Zhejiang POCTech CO., Ltd. 4 variants
Ref ZKCTT01301Model CT-301DC
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 | Number697114120CT301DC2K 06971141200618 | Date5 Mar 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- Withdrawn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
- Transmiters of Continuous Glucose Monitoring Systems
- Model / Reference
- CT-301DC, ZKCTT01301
- Primary DI / UDI-DI
- 06971141200618
- Basic UDI-DI
- 697114120CT301DC2K
- EMDN Code
- Z1204011599 Blood sugar monitoring systems - other
- Device Class
- Class IIb
- EU market of registration
- Italy
Manufacturer details
- EUDAMED SRN
- CN-MF-000024556
- Authorised representative
- Prolinx GmbH DE-AR-000005129
Other devices from Zhejiang POCTech CO., Ltd.
Properties
Other properties (13)
- Sterile: No
- 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
- Measuring Function: No
- Incorporates Medicinal Product: No